By study stage & trial size
Teams need an EDC or trial stack that fits early-stage protocol complexity without enterprise overhead.
EDC for Phase 1 Clinical Trials
Electronic data capture built for Phase 1 trials: protocol flexibility, safety reporting, and 21 CFR Part 11–compliant…
Learn moreEDC for Phase 1a Clinical Trials
EDC for Phase 1a trials: first-in-human safety, dose escalation, and PK/PD in one platform with 21 CFR Part…
Learn moreEDC for Phase 1b Clinical Trials
Electronic data capture for Phase 1b trials: patient cohorts, efficacy signals, and safety in one platform with 21 CFR…
Learn moreEDC for First-in-Human (FIH) Studies
Electronic data capture for first-in-human studies: safety, consent, and PK in one platform with 21 CFR Part…
Learn moreEDC for Phase 2 Clinical Trials
EDC for Phase 2 trials: efficacy, safety, and multi-site support in one platform with 21 CFR Part 11–compliant…
Learn moreEDC for Early-Stage Clinical Trials
Electronic data capture for early-stage trials: Phase 1–2 flexibility, safety and efficacy, and 21 CFR Part…
Learn moreBy study type & modality
Buyer is researching the right software stack for a specific study design or modality.
EDC for Observational Studies
EDC for observational studies: prospective and retrospective data capture, eConsent, ePRO, and 21 CFR Part…
Learn moreEDC for Real-World Evidence (RWE) Studies
EDC for real-world evidence studies: RWD collection, eConsent, ePRO, and 21 CFR Part 11–compliant controls for…
Learn moreEDC for Real-World Data (RWD) Studies
EDC for real-world data studies: RWD collection, eConsent, ePRO, and 21 CFR Part 11–compliant controls for analysis…
Learn moreEDC for Registry Studies
EDC for registry studies: long-term data capture, eConsent, ePRO, and 21 CFR Part 11–compliant controls in one platform.
Learn moreePRO for Patient-Reported Outcome Studies
ePRO for patient-reported outcome studies: PRO and eCOA in one platform with EDC, 21 CFR Part 11–compliant controls,…
Learn moreEDC for Quality of Life Studies
EDC for quality of life studies: QoL and PRO capture, eConsent, ePRO, and 21 CFR Part 11–compliant controls in one…
Learn moreComparisons & evaluation
Buyer is actively comparing vendors or looking for a lighter/faster option.
Medidata Alternatives
Compare Medidata alternatives for EDC and clinical trial software: lighter, faster options with eConsent, ePRO, and 21…
Learn moreMedidata Rave Alternatives
Compare Medidata Rave alternatives: EDC and clinical trial software with eConsent, ePRO, and 21 CFR Part 11–compliant…
Learn moreVeeva EDC Alternatives
Compare Veeva EDC alternatives: EDC and clinical trial software with eConsent, ePRO, and 21 CFR Part 11–compliant…
Learn moreCastor EDC Alternatives
Compare Castor EDC alternatives: EDC and clinical trial software with eConsent, ePRO, and 21 CFR Part 11–compliant…
Learn moreOpenClinica Alternatives
Compare OpenClinica alternatives: EDC and clinical trial software with eConsent, ePRO, and 21 CFR Part 11–compliant…
Learn moreREDCap Alternatives
Compare REDCap alternatives: EDC and clinical trial software with eConsent, ePRO, and 21 CFR Part 11–compliant…
Learn moreBy feature
Buyer has identified a needed capability and wants to shortlist tools that include it.
EDC with Built-in ePRO
EDC with built-in ePRO: one platform for data capture, eConsent, and patient-reported outcomes with 21 CFR Part…
Learn moreEDC with eConsent
EDC with eConsent: one platform for data capture and electronic informed consent with 21 CFR Part 11–compliant controls.
Learn moreEDC with Randomization
EDC with randomization: allocation, eConsent, and data capture in one platform with 21 CFR Part 11–compliant controls.
Learn moreEDC with Patient Enrollment Tools
EDC with patient enrollment tools: screening, consent, and data capture in one platform with 21 CFR Part 11–compliant…
Learn moreEDC with Study Builder
EDC with study builder: configure visits, forms, and logic in one platform with 21 CFR Part 11–compliant controls.
Learn moreEDC with Drag-and-Drop CRF Builder
EDC with drag-and-drop CRF builder: build case report forms without code, with 21 CFR Part 11–compliant controls.
Learn moreCost, speed & operations
Buyer is frustrated by cost, complexity, or implementation time and is seeking a lighter way to launch.
Affordable EDC for Clinical Trials
Affordable EDC for clinical trials: eConsent, ePRO, and 21 CFR Part 11–compliant controls without enterprise pricing.…
Learn moreLow-Cost Clinical Trial Software
Low-cost clinical trial software: EDC with eConsent, ePRO, and 21 CFR Part 11–compliant controls. See how it works.
Learn moreFastest Way to Launch a Clinical Trial
Fastest way to launch a clinical trial: EDC with eConsent, ePRO, and 21 CFR Part 11–compliant controls. Rapid build…
Learn moreClinical Trial Platform for Small Studies
Clinical trial platform for small studies: EDC with eConsent, ePRO, and 21 CFR Part 11–compliant controls. See how it…
Learn moreClinical Trial Software for <100 Patients
Clinical trial software for under 100 patients: EDC with eConsent, ePRO, and 21 CFR Part 11–compliant controls. See…
Learn moreClinical Trial Software for Small Teams
Clinical trial software for small teams: EDC with eConsent, ePRO, and 21 CFR Part 11–compliant controls. See how it…
Learn moreProcurement & education
Buyer is building a shortlist, requirements list, or internal case for selecting software.
How to Choose an EDC System
How to choose an EDC system: selection criteria, checklist, and common mistakes. EDC with eConsent, ePRO, and 21 CFR…
Learn moreEDC Vendor Comparison Guide
EDC vendor comparison guide: selection criteria, checklist, and how to compare EDC systems. 21 CFR Part 11–compliant…
Learn moreEDC Procurement Checklist
EDC procurement checklist: selection criteria for buying EDC with eConsent, ePRO, and 21 CFR Part 11–compliant…
Learn moreClinical Trial Software Selection Guide
Clinical trial software selection guide: criteria, checklist, and common mistakes. EDC with eConsent, ePRO, and 21 CFR…
Learn moreEDC for Clinical Trial Sponsors
EDC for clinical trial sponsors: selection criteria and fit for sponsor-led studies. EDC with eConsent, ePRO, and 21…
Learn moreEDC for Clinical Trial Investigators
EDC for clinical trial investigators: selection criteria and fit for investigator-led studies. EDC with eConsent,…
Learn moreePRO & patient diaries
Teams need a simple way to collect patient-reported data digitally and keep participants compliant.
ePRO Software for Clinical Trials
ePRO software for clinical trials: collect patient-reported data digitally with 21 CFR Part 11–compliant controls.…
Learn morePatient Diary Software for Clinical Trials
Patient diary software for clinical trials: digital diaries and symptom tracking with 21 CFR Part 11–compliant…
Learn moreDigital Patient Diary for Clinical Studies
Digital patient diary for clinical studies: collect patient-reported data with 21 CFR Part 11–compliant controls.…
Learn morePatient Symptom Tracking for Clinical Trials
Patient symptom tracking for clinical trials: digital symptom and event tracking with 21 CFR Part 11–compliant…
Learn moreePRO for Phase 1 Clinical Trials
ePRO for Phase 1 clinical trials: patient-reported outcomes with 21 CFR Part 11–compliant controls. Integrated with…
Learn moreePRO for Small Clinical Trials
ePRO for small clinical trials: patient-reported outcomes with 21 CFR Part 11–compliant controls. Integrated with EDC…
Learn moreeConsent
Buyers need a compliant and simpler way to handle participant consent, especially remotely or across sites.
eConsent Software for Clinical Trials
eConsent software for clinical trials: electronic informed consent with 21 CFR Part 11–compliant controls. Integrated…
Learn moreRemote Patient Consent for Clinical Trials
Remote patient consent for clinical trials: electronic consent with 21 CFR Part 11–compliant controls. End-to-end…
Learn moreDigital Informed Consent Software
Digital informed consent software: electronic consent with version control, e-signature, and 21 CFR Part 11–compliant…
Learn moreeConsent for Decentralized Clinical Trials
eConsent for decentralized clinical trials: electronic consent with 21 CFR Part 11–compliant controls. End-to-end…
Learn moreeConsent for Academic Clinical Research
eConsent for academic clinical research: electronic consent with 21 CFR Part 11–compliant controls. Lean teams, budget…
Learn moreeConsent for Multi-Site Clinical Trials
eConsent for multi-site clinical trials: electronic consent with 21 CFR Part 11–compliant controls. One platform…
Learn moreEnrollment & screening
Teams want to reduce manual screening and make enrollment easier for sites and patients.
Clinical Trial Patient Enrollment Software
Clinical trial patient enrollment software: screening, consent, and enrollment in one platform with 21 CFR Part…
Learn morePatient Recruitment Software for Clinical Trials
Patient recruitment software for clinical trials: screening, consent, and enrollment in one platform with 21 CFR Part…
Learn moreOnline Patient Screening for Clinical Trials
Online patient screening for clinical trials: eligibility screening and enrollment in one platform with 21 CFR Part…
Learn moreClinical Trial Pre-Screening Tools
Clinical trial pre-screening tools: eligibility and pre-screening in one platform with 21 CFR Part 11–compliant…
Learn morePatient Eligibility Screening Software
Patient eligibility screening software: eligibility checks and enrollment in one platform with 21 CFR Part…
Learn moreClinical Trial Enrollment Platforms
Clinical trial enrollment platforms: screening, consent, and enrollment in one platform with 21 CFR Part 11–compliant…
Learn moreDecentralized & remote trials
Buyer wants one stack that supports remote participation, data capture, and consent.
Decentralized Clinical Trial Software
Decentralized clinical trial software: one stack for remote participation, consent, and data capture. 21 CFR Part…
Learn moreSoftware for Remote Clinical Trials
Software for remote clinical trials: one stack for remote participation, consent, and data capture. 21 CFR Part…
Learn moreVirtual Clinical Trial Platforms
Virtual clinical trial platforms: one stack for remote participation, consent, and data capture. 21 CFR Part…
Learn moreRemote Patient Monitoring for Clinical Trials
Remote patient monitoring for clinical trials: consent, ePRO, and data capture in one platform. 21 CFR Part…
Learn moreDigital Clinical Trial Platforms
Digital clinical trial platforms: one stack for consent, data capture, and ePRO. 21 CFR Part 11–compliant controls.
Learn moreHybrid Clinical Trial Software
Hybrid clinical trial software: one stack for site and remote participation, consent, and data capture. 21 CFR Part…
Learn moreRandomization
Buyer needs fast, reliable treatment assignment without building a custom process.
Clinical Trial Randomization Software
Clinical trial randomization software: treatment assignment with 21 CFR Part 11–compliant controls. Common methods,…
Learn moreBlock Randomization Software
Block randomization software: block-based treatment assignment with 21 CFR Part 11–compliant controls. Integrated with…
Learn moreRandomization Tools for Clinical Trials
Randomization tools for clinical trials: treatment assignment with 21 CFR Part 11–compliant controls. Common methods,…
Learn moreRandomization Software for Small Studies
Randomization software for small studies: treatment assignment with 21 CFR Part 11–compliant controls. Integrated with…
Learn moreRandomization Without CRO
Randomization without CRO: treatment assignment with 21 CFR Part 11–compliant controls. Integrated with EDC and…
Learn moreStudy setup & build
Teams want to get from protocol to live study quickly without heavy configuration cycles.
Clinical Trial Study Builder Software
Clinical trial study builder software: get from protocol to live study quickly. 21 CFR Part 11–compliant controls.
Learn moreProtocol-to-Study Setup Software
Protocol-to-study setup software: get from protocol to live study quickly. 21 CFR Part 11–compliant controls.
Learn moreClinical Trial Study Design Tools
Clinical trial study design tools: configure visits, forms, and logic. 21 CFR Part 11–compliant controls.
Learn moreSoftware to Build Case Report Forms (CRFs)
Software to build case report forms (CRFs): configure CRFs without code. 21 CFR Part 11–compliant controls.
Learn moreCRF Builder for Clinical Trials
CRF builder for clinical trials: build case report forms without code. 21 CFR Part 11–compliant controls.
Learn moreClinical Trial Workflow Software
Clinical trial workflow software: get from protocol to live study quickly. 21 CFR Part 11–compliant controls.
Learn moreInvestigator & site operations
Sites and coordinators need software that reduces administrative burden and keeps study tasks in one place.
Clinical Trial Software for Investigators
Clinical trial software for investigators: reduce administrative burden and keep study tasks in one place. 21 CFR Part…
Learn moreSoftware for Research Coordinators
Software for research coordinators: reduce administrative burden and keep study tasks in one place. 21 CFR Part…
Learn moreClinical Trial Software for Study Sites
Clinical trial software for study sites: reduce administrative burden and keep study tasks in one place. 21 CFR Part…
Learn moreInvestigator Portal for Clinical Trials
Investigator portal for clinical trials: one place for enrollment, consent, and data capture. 21 CFR Part 11–compliant…
Learn moreSoftware for Clinical Research Teams
Software for clinical research teams: one place for enrollment, consent, and data capture. 21 CFR Part 11–compliant…
Learn moreWhite-Label EDC for Small & Virtual CROs
Give your sponsors a modern EDC, eConsent and ePRO stack without buying enterprise licenses or building your own.…
Learn moreFor academic & research
Academic and investigator-led teams need simpler tools, often with smaller budgets and lean operations.
Clinical Trial Software for Universities
Clinical trial software for universities: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Lean teams,…
Learn moreResearch Data Capture for Academic Studies
Research data capture for academic studies: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Lean teams,…
Learn moreClinical Research Software for Universities
Clinical research software for universities: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Lean teams,…
Learn moreSoftware for Investigator-Initiated Trials
Software for investigator-initiated trials: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Lean teams,…
Learn moreDigital Tools for Academic Clinical Research
Digital tools for academic clinical research: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Lean teams,…
Learn moreClinical Trial Software for Research Institutes
Clinical trial software for research institutes: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Lean…
Learn moreFor early-stage biotech
Small sponsor teams need an affordable, fast stack without enterprise implementation cycles.
Clinical Trial Platform for Early-Stage Biotech
Clinical trial platform for early-stage biotech: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Speed,…
Learn moreSoftware for Small Biotech Clinical Trials
Software for small biotech clinical trials: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Speed,…
Learn moreAffordable Clinical Trial Software for Biotech
Affordable clinical trial software for biotech: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Speed,…
Learn moreClinical Trial Platforms for Seed-Stage Biotech
Clinical trial platforms for seed-stage biotech: EDC, eConsent, ePRO with 21 CFR Part 11–compliant controls. Speed,…
Learn moreClinical Trial Software for Biotech Founders
Run your first study without a CRO or a technical team. Build it yourself, test it free, and see exactly what your…
Learn moreClinical Trial Software for Medtech Startups
Clinical trial software for medtech startups: run a first-in-human or feasibility device study with no enterprise…
Learn moreProblem to solution
Searcher has an operational problem and is looking for a practical way to solve it, often before naming a vendor category.
How to Run a Clinical Trial Without a CRO
How to run a clinical trial without a CRO: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21 CFR…
Learn moreTools for Running a Clinical Trial Internally
Tools for running a clinical trial internally: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21…
Learn moreSoftware to Manage a Clinical Trial
Software to manage a clinical trial: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21 CFR Part…
Learn moreTools to Launch a Clinical Trial Fast
Tools to launch a clinical trial fast: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21 CFR Part…
Learn moreSoftware for Small Clinical Research Teams
Software for small clinical research teams: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21 CFR…
Learn moreHow to Run a Clinical Trial with a Small Team
How to run a clinical trial with a small team: steps, common blockers, and tool options. EDC, eConsent, ePRO with 21…
Learn moreTools & resources
Searcher is mapping the software stack needed to launch or run a study.
Clinical Trial Tools for Startups
Clinical trial tools for startups: overview, tool categories, and what teams need. EDC, eConsent, ePRO with 21 CFR…
Learn moreDigital Tools for Clinical Research
Digital tools for clinical research: overview, tool categories, and what teams need. EDC, eConsent, ePRO with 21 CFR…
Learn moreSoftware Stack for Running a Clinical Trial
Software stack for running a clinical trial: overview, tool categories, and what teams need. EDC, eConsent, ePRO with…
Learn moreTools Needed to Run a Clinical Trial
Tools needed to run a clinical trial: overview, tool categories, and what teams need. EDC, eConsent, ePRO with 21 CFR…
Learn moreCompliance & Regulatory
Regulatory or QA staff need to verify a vendor against Part 11 requirements before sign-off.
21 CFR Part 11 Compliance Checklist for Clinical Trials
A working checklist for 21 CFR Part 11: electronic records, audit trails and electronic signatures, with the specific…
Learn moreALCOA+ Data Integrity Checklist for Clinical Trials
ALCOA+ means data that is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete, Consistent,…
Learn moreGDPR-Compliant Clinical Trial Software
GDPR needs EU hosting, encryption and role-based access, not a vendor badge. See the exact controls Capture provides…
Learn moreHIPAA-Compliant Clinical Trial Software
HIPAA needs encrypted PHI, role-based access and an audit trail, not a vendor badge. See the exact safeguards Capture…
Learn moreClinical Trial Diversity Action Plan Guide
FDORA requires a Diversity Action Plan for many pivotal trials. See what it covers and the EDC features that support…
Learn moreComputer System Validation (CSV) for Clinical Trial Software
Computer system validation is the sponsor's job, not just the vendor's. See what CSV requires and the documentation…
Learn moreCompliance & Regulatory
Study teams have heard about E6(R3) and need a plain-language summary of what changed and what to do.
ICH E6(R3) Guide for Clinical Trial Teams
What changed in ICH E6(R3): risk-based quality management, more flexible trial designs, and what small trial teams…
Learn moreFDA Expedited IND Pilot Program Guide
FDA's Expedited IND Pilot pairs sponsors with a Qualified Research Institution for rolling IND review. Applications…
Learn moreFDA Operation Trialblazer Guide
HHS's Operation Trialblazer aims to cut US clinical trial timelines roughly in half. See what it actually changes and…
Learn moreBayesian Clinical Trial Design Guide
FDA's January 2026 draft guidance sets out how it expects Bayesian trial designs to be built. See what changed and…
Learn moreBy feature
Buyer needs to confirm exactly how audit trail logging works before choosing a system.
Audit Trail Software for Clinical Trials
A clinical trial audit trail logs every data change: who, when, old value, new value and why. Here is how Capture’s…
Learn moreElectronic Signatures for Clinical Trials
How electronic signatures work in Capture: participant signature, email OTP verification, and password-authenticated…
Learn moreEducation
Team has decided to leave REDCap and needs a concrete migration path.
How to Migrate from REDCap
A practical migration path from REDCap: export your data dictionary, let AI draft your new forms from it, and merge…
Learn moreHow to Switch EDC Vendors Mid-Study
Switching EDC vendors during a trial: when it is worth it, the risks, a step-by-step migration plan, what to keep from…
Learn moreCost, speed & operations
Vendor-managed EDC change control turns a small protocol amendment into a weeks-long, billed process.
Compliance & Regulatory
EU sponsors need a plain-language explanation of EU CTR and where their software already fits.
EU CTR & CTIS Guide for Clinical Trial Teams
The EU Clinical Trials Regulation now covers every EU trial through CTIS. Here is what changed and where Capture…
Learn moreFDA Digital Health Technologies (DHT) Guidance for Trials
FDA digital health technologies guidance explained: DHT selection, verification and validation, the durable data…
Learn moreEU AI Act and Clinical Trial Software
EU AI Act and clinical trials: risk classes, the revised 2027 and 2028 high-risk dates after the AI omnibus, and what…
Learn moreUK MHRA Clinical Trial Regulations: What Changes for Data Systems
MHRA clinical trials regulations in force from 28 April 2026: combined review, notifiable trials, modifications,…
Learn moreEMA Guideline on Computerised Systems: What EDC Buyers Need
The EMA computerised systems and electronic data guideline for clinical trials explained: ALCOA++, audit trail review,…
Learn moreICH E6(R3) Annex 2 Guide
ICH E6(R3) Annex 2 explained: GCP for decentralised elements, pragmatic designs and real-world data, with ICH, EU and…
Learn moreFree Tools & Calculators
Teams planning a trial need a fast, working sample size estimate before they get a biostatistician involved.
Clinical Trial Sample Size Calculator
Free two-proportion sample size calculator for clinical trials. Set your response rates, alpha and power, and get a…
Learn moreRandomization List Generator for Clinical Trials
Free block randomization list generator. Pick your arms, block size and sample size, and get a reproducible allocation…
Learn moreClinical Trial Timeline Calculator
Free clinical trial timeline calculator: estimate first participant in, last participant in, database lock and topline…
Learn moreClinical Trial Cost-per-Patient Calculator
Free clinical trial cost per patient calculator: turn a budget into cost per enrolled, randomized and evaluable…
Learn moreDropout-Adjusted Sample Size Calculator
Free sample size calculator with dropout and attrition: enter evaluable N and expected dropout to get the number to…
Learn moreSurvival Analysis Sample Size Calculator (Log-Rank)
Free log-rank sample size calculator for time-to-event trials: enter hazard ratio, alpha and power to get required…
Learn moreBuying guides
Buyers cannot find real EDC pricing anywhere and need a reference point before talking to vendors.
Alternatives / Best-of
Buyers researching "best EDC software" get vendor marketing pages instead of a neutral fit comparison.
Best EDC Software (2026 Roundup)
An honest, per-vendor roundup of EDC software in 2026: REDCap, Castor, Medrio, Viedoc, Medidata, Veeva and…
Learn moreFree EDC Software (Honest List)
What is actually free in EDC software in 2026: REDCap, OpenClinica Community Edition and Capture’s free sandbox, and…
Learn moreInvestigator & site operations
Independent sites juggle a different sponsor-provided system for every protocol instead of owning one stack of their own.
Compliance features
Sponsors and sites need to be ready for an FDA or EMA inspection at any time, not scramble to reconstruct records when one is announced.
Randomization
Capture randomizes the subject, proposes the right kits, records the dispensing under an e-signature and keeps every role correctly blinded. No separate IRT vendor, no integration to maintain.
RTSM Software for Clinical Trials
Randomize, dispense and track investigational product in the same system as your EDC, with enrolment caps, blinded…
Learn moreIMP Inventory and Drug Accountability Software
Track every investigational product kit from depot to destruction: shipments, receipt, quarantine, dispensing, returns…
Learn moreBlinded and Unblinded Role Management in EDC
Blinded and unblinded roles in EDC: who needs the treatment arm, who must never see it, and how Capture withholds it…
Learn moreCompliance & Regulatory
Electronic signatures that re-check the signer, an audit trail nobody can edit, server-set timestamps and sessions that end after inactivity. The controls Part 11 asks for are part of how Capture stores data, not a setting to switch on.
21 CFR Part 11 Compliant EDC
The Part 11 controls built into Capture: re-authenticated e-signatures, a tamper-evident audit trail, server…
Learn moreRole-Based Access Control for Clinical Trials
Role-based access control in clinical trial software: study roles, site separation, identity separated from data,…
Learn moreAnnex 11 Compliant EDC
Looking for an Annex 11 compliant EDC? See which Annex 11 expectations an EDC can cover, which stay with the sponsor,…
Learn moreEDC Audit Trail Export for Inspectors
EDC audit trail export for inspection: field-level, append-only, hash-chained records you can export and explain to an…
Learn moreGAMP 5 Validation for EDC Systems
GAMP 5 EDC validation explained: software categories, risk-based testing, and what the sponsor validates versus what…
Learn moreRemote Identity Verification for eConsent
Remote identity verification for eConsent: the options from email OTP to ID scan, what regulators expect, and exactly…
Learn moreSafety
Capture enforces the regulatory minimum dataset on every AE, routes serious events to the right people and collects investigator sign-off under an e-signature. Safety data sits in the same record as the rest of the study.
Adverse Event Reporting Software for Clinical Trials
Record AEs, SAEs and AESIs with the minimum dataset enforced, investigator sign-off, safety alerts routed to the right…
Learn moreAE Causality Assessment Workflow
Adverse event causality assessment explained: WHO-UMC and Naranjo categories, who decides, and how Capture records the…
Learn moreData Management & Monitoring
See what is missing, query what is wrong, freeze and lock what is clean, and export analysis-ready data with a dictionary. Every step is recorded, including each export.
Clinical Data Management Software
Review, query, freeze and lock clinical data in one place, then export analysis-ready CSV or Excel with codes, labels,…
Learn moreEdit Checks Software for Clinical Trials
Clinical trial edit checks explained: range, required, custom and date checks, soft versus hard checks, writing an…
Learn moreDatabase Lock Software for Clinical Trials
Database lock software for clinical trials: freezing and locking data by field or in bulk, unlocking with reasons,…
Learn moreMedication Adherence and Pill Count Capture
Medication adherence tracking in clinical trials: the pill-count formula, 80 to 120% ranges, diaries vs smart caps and…
Learn moreCDISC SDTM Export Software
CDISC SDTM export software that turns your eCRFs into SDTM datasets as SAS XPT files with Define-XML. How SDTM differs…
Learn moreExport EDC Data to R, SAS, SPSS and Stata
Export EDC data to R, SAS, SPSS or Stata: wide CSV or Excel with a data dictionary, raw and decoded files, SDTM XPT,…
Learn moreData Management & Monitoring
Mark which fields need source data verification, change it as risk changes, and let monitors spend their visits where it counts. Every configuration change is versioned with a reason.
Risk-Based Monitoring and SDV Software
Target source data verification at the fields that matter. Set SDV per field, version every change, track site risk…
Learn moreProtocol Deviation Tracking Software
ICH E6(R3) expects deviation tracking tied to your risk assessment. See how Capture's edit checks, queries and audit…
Learn moreReal-Time Clinical Trial Dashboard Software
Real-time clinical trial dashboard software: enrolment, diary compliance, safety and site risk in one view, filtered…
Learn moreePRO & patient diaries
Patients, caregivers, clinicians and performance tests all report into the same study record. Each assessment knows who completes it and on what device, and it all runs in the browser.
eCOA Software for Clinical Trials
Collect every clinical outcome assessment electronically: PRO, ObsRO, ClinRO and PerfO, on participant phones, home…
Learn moreePRO Compliance Reminders by SMS and Email
Improve ePRO and diary compliance with reminders by email and SMS: a three-step reminder ladder, quiet hours in each…
Learn moreData Management & Monitoring
Each site's laboratory carries its own reference ranges by sex and age. Values outside range are flagged at entry, alert values notify the right people, and a clinically significant result can become an AE in one step.
Study setup & build
Build the study from your protocol, hand ethics the documents they need, activate each site against a checklist and launch only when everything is ready. All in the same system your sites will use.
By study type & modality
Oncology trials live or die on safety data quality and dosing accuracy. Capture gives you AE and SAE forms, BSA-based dose calculations, and randomization for blinded arms, all in one audit trail, so a small oncology team can run the same rigor as a large one.
EDC for Oncology Clinical Trials
EDC for oncology trials: dose-escalation cohorts, AE/SAE and AESI forms, BSA-based dosing calculations, and…
Learn moreEDC for Cardiology Clinical Trials
EDC for cardiology trials: ECG and vitals templates, QTc/QTcF and MAP calculated automatically, and edit checks that…
Learn moreEDC for Rare Disease Clinical Trials
Rare disease trials need small-N flexibility, registry support and caregiver-reported outcomes. See how Capture's EDC…
Learn moreEDC for Psychiatry Clinical Trials
EDC for psychiatry trials: clinician rating scales, rater attribution, prospective suicidality assessment, participant…
Learn moreEDC for Alzheimer's and Dementia Clinical Trials
EDC for Alzheimer's trials: cognitive and functional scales, study partner reports, consent with legally authorised…
Learn moreEDC for Diabetes Clinical Trials
EDC for diabetes trials: HbA1c units and lab ranges, CGM time-in-range metrics, hypoglycaemia event logs by level,…
Learn moreInvestigator & site operations
Running clinical operations across several sites usually means chasing enrollment numbers, open queries and SDV status through separate spreadsheets and emails. Capture puts all three in one dashboard, filtered by site, with role-based access so each person sees exactly what their role needs.
Procurement & education
Many IRB submission delays trace back to the data management section: no blank CRF for reviewers to see, no documented consent workflow, no clear answer on data security or who can access participant data. This checklist covers what an IRB or ethics committee typically asks for on the data capture side, and where Capture already has the answer.
IRB Submission Checklist for Clinical Trials
What most IRBs ask for on the data capture side before approving a study: a data management plan, a documented consent…
Learn moreHow to Design a Clinical Research Questionnaire
How to design a research questionnaire for a clinical study: when to use a validated instrument, writing items, recall…
Learn moreHow to Run a Pilot Study
How to run a pilot study: feasibility objectives, progression criteria, sample size rules of thumb, the CONSORT…
Learn moreHow to Migrate from OpenClinica to a Cloud EDC
A practical path from OpenClinica to a cloud EDC: export data and form definitions, let AI draft forms, rebuild logic,…
Learn moreHow to Migrate from Castor EDC to Capture
Moving from Castor EDC to Capture: export data and definitions, let AI draft forms, rebuild logic, test free and merge…
Learn moreHow to Move from Excel Spreadsheets to an EDC Mid-Study
Move clinical trial data from Excel to an EDC, even mid-study: draft forms from your sheet with AI, cut over on one…
Learn moreDecentralized & remote trials
Decentralized and hybrid trials move some or all data collection outside the clinic: eConsent instead of a paper signature at a desk, ePRO diaries instead of a site-only visit, and coordination across more than one location. This guide covers the stack a DCT actually needs and where each piece fits.
Procurement & education
An EDC captures the clinical data a study collects, subject by subject, field by field. An eTMF (electronic Trial Master File) stores the regulatory and administrative documents that prove a trial was run correctly: signed protocols, IRB approvals, monitoring visit reports, delegation logs. Capture includes both: an EDC, eConsent and ePRO platform with a built-in eTMF. This page explains where each one fits.
EDC vs eTMF: What is the Difference
An EDC captures participant data; an eTMF stores regulatory documents. Capture includes both in one platform. Here is…
Learn moreEDC vs CTMS: What is the Difference
An EDC captures clinical data; a CTMS manages the operational side of a trial. Capture includes both in one platform.…
Learn moreeTMF vs a Shared Drive
eTMF vs shared drive for trial documents: what a shared drive cannot evidence, when it can be enough, and when a…
Learn moreRegulatory guides
On February 18, 2026, FDA announced that one adequate, well-controlled trial plus confirmatory evidence is now the default bar for marketing authorization, instead of two trials. A companion Plausible Mechanism framework goes further for rare disease programs. Here is what sponsors need to plan for, and what it means for your data.
Locations
UK trials sit under their own regulator, data protection law and research ethics system. Capture supports UK sponsors, clinical trials units and NIHR-funded academic teams with the audit trail, signature and access controls MHRA inspectors expect.
Clinical Trial Software in the UK
Clinical trial software for UK studies: MHRA and combined review, UK GDPR, data integrity expectations, NIHR-funded…
Learn moreClinical Trial Software in Ireland
Clinical trial software for studies in Ireland: HPRA and the EU CTR, national research ethics committees, Ireland's…
Learn moreClinical Trial Software in Latvia
Clinical trial software for Latvian and Baltic studies: EU CTR and the State Agency of Medicines, GDPR, EU hosting in…
Learn moreClinical Trial Software in Singapore
Clinical trial software for studies in Singapore: HSA authorisation routes, ethics review, the PDPA and cross-border…
Learn moreClinical Trial Software in South Korea
Clinical trial software for South Korean studies: MFDS approval, institutional review boards, the Personal Information…
Learn moreClinical Trial Software in Brazil
Clinical trial software for studies in Brazil: ANVISA, the CEP/CONEP ethics system and Plataforma Brasil, the LGPD,…
Learn moreComparisons & evaluation
Both are established enterprise platforms used by large sponsors and CROs. The right choice depends less on feature lists than on your existing systems, your team's experience and how your studies change. Here is a neutral way to compare them, and when a lighter option fits better.
Medidata Rave vs Veeva Vault EDC
Medidata Rave vs Veeva Vault EDC: a neutral framework for comparing the two enterprise EDC platforms, the questions to…
Learn moreREDCap vs Castor
REDCap vs Castor EDC compared neutrally: institution-hosted and consortium-licensed versus commercial cloud, support,…
Learn moreREDCap vs Qualtrics
REDCap vs Qualtrics compared neutrally: a research data capture tool versus a survey and experience platform, hosting…
Learn moreOracle Clinical One vs Medidata Rave
Oracle Clinical One vs Medidata Rave: a neutral evaluation framework, the written questions to ask both vendors, and a…
Learn moreREDCap vs Excel
REDCap vs Excel: if your choice is a research database or a spreadsheet, here is what each does well, where each…
Learn moreCastor EDC vs Medidata Rave
Castor EDC vs Medidata Rave compared neutrally: build model, modules, cost structure, what to test, and when a lean…
Learn moreData Management & Monitoring
Data managers design the forms, write the checks, chase the queries and sign off the lock. Capture gives you the tools for each step in one system, without waiting on a vendor for every change.
Software for Clinical Data Managers
Clinical trial software for data managers: AI-drafted forms, edit checks with auto-queries, query management, SDV…
Learn moreEDC for Biostatisticians and SAS Programmers
What biostatisticians and SAS or R programmers need from an EDC: coded exports with data dictionaries, raw and decoded…
Learn moreClinical Trial Software for Clinical Data Scientists
Clinical trial software for clinical data scientists: traceable source data, derived variables, SDTM and CSV exports,…
Learn moreCompliance & Regulatory
Quality assurance needs evidence: who did what, when, why, and whether they were allowed to. Capture records it by design, with an append-only audit trail, re-authenticated signatures and role-based access you can review and export.
Clinical Trial Software for Quality Assurance
What QA teams need from clinical trial software: audit trails they can review, electronic signature controls, access…
Learn moreClinical Trial Software for Regulatory Affairs
What regulatory affairs teams need from trial software: blank eCRFs for submissions, controlled amendments, safety…
Learn moreEnrollment & screening
Put a QR code on a poster, a clinic room wall or an information leaflet, and let people reach your study in seconds. Capture creates site-specific or study-specific codes that open in the phone browser, with no app to install.
Comparisons & evaluation
REDCap is available at no licence cost to non-profit consortium members, which is why it is everywhere in academia. A licence is not a study, though. Here is the worksheet that adds up hosting, staff time, validation and support so the comparison with a hosted EDC is fair.
Academic Research
Build your forms and questionnaires, collect consent, enter data and export a clean dataset for your analysis, with a record of every change your examiners can trust. Start in the free sandbox: no credit card.
Data Collection Tool for Thesis Research
A data collection tool for thesis research with clinical-grade controls: forms, questionnaires, consent and an audit…
Learn moreEDC for Medical Student Research Projects
Data collection for medical student research projects: structured forms, consent and an audit trail that outlives the…
Learn moreePRO & patient diaries
EMA only works if people answer close to the moment. Capture sends short phone-browser surveys on a schedule, reminds participants by email or SMS, closes entries with completion windows and shows you who is falling behind, with no app to install.
Nutrition & Wellness
Start from the claim you want to make, not from the software. Capture helps you turn a claim into pre-specified endpoints, collect them with diaries and site forms, and keep the record that shows how the evidence was produced.
Academic Research
Students learn data management by doing it: building eCRFs, writing edit checks, answering queries, signing consent and reading the audit trail in an actual EDC. The sandbox has nearly every feature and no credit card, and it uses demo data only.
Data Management & Monitoring
A live study should never run on a form nobody approved. Capture moves every form from draft to approved, locks approved forms for live use and shows only approved forms in the casebook, so a mid-study change is a deliberate, reviewable step.
Procurement & education
Your portfolio companies are small teams with no IT department, a tight runway and a first trial that still has to stand up to a regulator. Capture gives each of them EDC, ePRO and eConsent with Part 11-compliant controls, a free sandbox to learn in, and no enterprise contract to start.
Use Case
A PEMF study is a device study with a long list of small events: sessions at home, settings, sham or active allocation, symptom diaries and adverse events. Capture holds all of it in one audited system, with ePRO, eConsent and randomisation, and you build it free in the sandbox.
EDC for PEMF / Magnetic Field Therapy Trials
EDC for PEMF and magnetic field therapy trials: session logs, sham-controlled arms, device adherence, adverse events…
Learn moreEarly Feasibility and Pivotal Device Study EDC
Device pivotal study EDC for medtech sponsors: deficiency and AE capture, procedure data, and form changes from early…
Learn moreOura Ring Clinical Trial Integration
Oura Ring clinical trial integration in Capture: study teams enable the device, participants connect their own Oura…
Learn moreUse Case
Neuromodulation studies mix a precise device protocol with clinician-rated and patient-reported scales. Capture records stimulation parameters per session, keeps sham allocation blinded, collects ratings and diaries, and logs side effects, with a free sandbox to build it first.
Use Case
Biological age studies live or die on sample handling, assay batches and repeat measures. Capture links each sample to a participant and a visit, stores lab and clock results with units and ranges, adds wearable and questionnaire data, and keeps an audit trail on every value.
Use Case
Studies of existing drugs in ageing populations have unusual dosing patterns, long safety follow-up and a mix of biomarker and function endpoints. Capture handles dosing diaries, safety labs, adverse events, randomisation and wearables in one audited system you can build free in the sandbox.
Use Case
A supplement study with a blood metabolite endpoint, daily intake and wellbeing outcomes needs more than a survey tool. Capture ties product lot, intake diary, blood results and safety checks to each participant, with a free sandbox to build and test it first.
Therapeutic Area
Sarcopenia studies measure muscle strength, mass and physical performance repeatedly, in older participants, often with exercise or nutrition interventions. Capture holds the timed tests, DXA results, questionnaires, falls and adverse events in one audited study, built free in the sandbox with no CRO set-up.
Comparisons & evaluation
Part 11 compliance is not a label a piece of software carries into your study. It is the result of the software, how it is hosted and configured, and the validation your organisation documents. Here is the checklist of what you must establish for REDCap, or for any tool, before regulated data goes in.
Is REDCap 21 CFR Part 11 Compliant?
Is REDCap 21 CFR Part 11 compliant? Compliance is shared between software and your institution. What sponsors must…
Learn moreREDCap for Industry-Sponsored Trials
Can you use REDCap for commercial or industry-sponsored trials? Licence terms to read, validation questions and…
Learn moreIs Qualtrics 21 CFR Part 11 Compliant?
Is Qualtrics 21 CFR Part 11 compliant? We found no public Part 11 statement. Here is what Part 11 requires, what to…
Learn moreCan You Use Airtable for a Clinical Trial?
Airtable for a clinical trial: fine for logistics, risky for regulated records. Revision history limits, permissions,…
Learn moreCan You Use Google Sheets for Clinical Trial Data?
Can you use Google Sheets for clinical trial data? Sharing, edit history and BAA scope explained, plus what you would…
Learn moreIs Excel Acceptable for Clinical Trial Data?
Is Excel compliant for clinical trial data? Part 11 certifies no tool. File control, macros, change-tracking limits…
Learn moreComparisons & evaluation
REDCap is a widely used research data capture tool; an EDC built for clinical trials is organised around sites, monitoring, queries and sign-off. Most studies do not need the second. Here are the triggers that tell you when yours does.
Procurement & education
A first trial is a sequence of decisions, not one big project. This roadmap walks a founding team from a signed-off idea to a locked database, and shows which parts you can run with a small team and a self-serve platform.
Running Your First Clinical Trial: A Startup Roadmap
How to run a clinical trial as a startup: a stage-by-stage roadmap from protocol to database lock, with the data tools…
Learn morePatient Recruitment Playbook for Small Trials
How to recruit patients for a clinical trial with a small team: feasibility, channels, pre-screening, consent and…
Learn moreClinicalTrials.gov Registration Step-by-Step
ClinicalTrials.gov registration how to: who must register, when, the PRS steps and how to keep the record aligned with…
Learn moreHow to Write a Clinical Trial Protocol
How to write a clinical trial protocol: structure, the SPIRIT 2025 checklist and how to make it buildable as eCRFs.…
Learn moreHow to Choose a CRO (and When You Do Not Need One)
How to choose a CRO: scope, selection criteria, questions to ask, contract traps and when to keep data capture…
Learn moreHow to Run a Clinical Trial on a Small Budget
How to run a clinical trial on a small budget: cut scope, consolidate tools, use risk-based monitoring and avoid…
Learn moreEducation
Longevity studies mix biomarkers, functional tests, wearable data and questionnaires over long follow-up. This guide walks through the decisions in the order you will meet them, and shows where the data capture work sits.
How to Run a Longevity Clinical Trial
How to run a longevity clinical trial: pick endpoints, plan the visit schedule, add wearable and patient-reported…
Learn moreHow to Set Up a Clinical Trial Database in a Day
How to set up a clinical trial database in a day: an hour-by-hour plan from protocol to tested forms, roles and…
Learn moreHow to Run a Clinical Trial from Scratch
How to run a clinical trial from scratch: a 12-step checklist from research question and protocol to ethics, consent,…
Learn moreePRO Compliance: Getting Patients to Complete Diaries
ePRO compliance rates explained: how to define and measure diary completion, what drives missed entries, and how to…
Learn moreInvestigator-Initiated Trial Start-Up Checklist
Investigator-initiated trial checklist for sponsor-investigators: regulatory, ethics, registration, safety, data and…
Learn moreParticipant Retention Strategies in Clinical Trials
Participant retention in clinical trials: why people drop out, which burden-reduction and contact strategies to plan,…
Learn moreEducation
EDC stands for electronic data capture: the system where a trial's data is entered, checked and stored. This guide explains what it does, the words you will hear, and the questions to ask before you pick one.
What Is EDC in Clinical Trials? A Plain-English Guide
What is EDC in clinical trials? A plain-English guide to electronic data capture: what it replaces, how data flows,…
Learn moreWhat Is eConsent? A Plain-English Guide
What is eConsent? Learn how electronic informed consent works in clinical trials, what the regulators say, benefits…
Learn moreWhat Is ePRO? A Plain-English Guide
What is ePRO? A plain-English guide to electronic patient-reported outcomes: instruments, how data is collected,…
Learn moreCDMS vs EDC: What Is the Difference?
CDMS vs EDC: how the clinical data management system differs from electronic data capture, where they overlap and…
Learn moreCompliance & Regulatory
Most interventional trials process health data from patients at a scale that makes a data protection impact assessment the default, not the exception. This template follows the minimum content in Article 35(7) of the GDPR and adds the trial-specific questions supervisory authorities and ethics committees ask about.
Free Tools & Calculators
Convert 20 common laboratory analytes between conventional units (mg/dL, g/dL, µg/dL) and SI units (mmol/L, µmol/L, g/L), including the non-linear HbA1c equation. Every factor is shown with its source.
Lab Value Unit Converter (SI and Conventional)
Free lab unit converter, SI to conventional and back: glucose, creatinine, lipids, bilirubin, haemoglobin, vitamin D,…
Learn moreCTCAE Grade Lookup (v5.0 and v6.0)
Free CTCAE v5 grading lookup: search 34 common adverse event terms and see Grade 1 to 5 criteria, side by side with…
Learn moreSAE / SUSAR Reporting Deadline Calculator (7 / 15 Day)
Free SAE reporting deadline calculator: enter the awareness dates to get the 24-hour, FDA 7- and 15-day, EU CTR and…
Learn moreeGFR Calculator (CKD-EPI 2021) for Eligibility Screening
Free eGFR calculator using the 2021 race-free CKD-EPI creatinine equation: mg/dL or µmol/L, GFR category G1 to G5, and…
Learn moreEligibility Criteria Checker for Clinical Trials
Eligibility criteria checker for clinical trials: turn inclusion and exclusion criteria into a checkable eCRF, with…
Learn moreCohen’s Kappa Calculator (Inter-Rater Agreement)
Cohen’s kappa calculator with the formula, a worked 2x2 example (kappa 0.70), 95% CI, weighted kappa, and when to use…
Learn moreBy study type & modality
When a nurse visits the participant instead of the participant visiting the clinic, the data still has to land on the same forms, with the same checks, under the same audit trail. Capture lets a visiting nurse enter the visit in a browser, as a named site user, against the visit the protocol defines.
For academic & research
A prospective cohort lives or dies on repeat contact: the same people, measured the same way, wave after wave. Capture schedules each wave with a window, sends the questionnaires by link, lets staff enter clinic measures, and records every change.
eConsent
When a participant cannot give consent themselves, someone with legal authority signs for them. Capture supports a Legally Authorized Representative (LAR) signature in the same eConsent workflow, with email one-time code verification, investigator countersignature and an exportable signed PDF.
Legally Authorized Representative Consent Software
Legally authorized representative consent in eConsent: record who signed for the participant, add a witness if needed,…
Learn moreImpartial Witness Signature in eConsent
Impartial witness eConsent: when ICH-GCP, the FDA and the EU CTR need a witness, and how Capture adds an optional…
Learn moreSafety
A SUSAR is a serious adverse reaction that is also unexpected. Getting there takes three judgements and a clock. Capture captures the SAE with the minimum dataset, raises an alert, records causality and sign-off, and keeps the timeline, so the sponsor’s safety team can decide and submit in time.
Study setup & build
UAT is where the people who will use the study database check that it does what the protocol and data management plan say. Capture gives you a free sandbox with nearly every feature, no credit card, so you can build the study, run your scripts and sign off.
Audience pages
Your product is software, but the evidence still has to look like a clinical trial. Capture gives a lean DTx team an audited EDC, ePRO in the phone browser and eConsent in one system, so the pivotal study does not need a five-vendor stack or an enterprise sales cycle.
Clinical Validation Software for Digital Therapeutics
Clinical validation software for digital therapeutics: capture trial-grade data, ePRO and eConsent in one audited…
Learn moreOutcomes Tracking Software for Longevity Clinics
Outcomes tracking software for longevity clinics: structured baseline and follow-up data, PROs, wearable sync and…
Learn morePilot EDC for Pharma Clinical Operations
Pilot EDC software for pharma: run one study outside your enterprise EDC contract, test in a free sandbox, then expand…
Learn moreClinical Trial Software for SMOs and Site Networks
SMO clinical trial software for site networks: site coordinator portal, QR enrollment, site-level numbering, by-site…
Learn moreFree Tools & Calculators
Tick the outcomes the event had, then enter severity, causality and expectedness. The tree returns whether the event is serious, which criteria it meets, and whether it is a SUSAR candidate, with a summary you can paste into the AE form.
Free Tools & Calculators
Pick the type of deviation and answer four impact questions: rights, safety, key data and analysis population. The tool suggests important (major) or non-important (minor), flags repeated or intentional patterns, and gives you a log entry to paste.
Free Tools & Calculators
Fill in the title, design, population, objectives, endpoints, criteria, statistics and safety fields and get a clean synopsis under standard headings, with empty sections marked. Copy it into your protocol, ethics submission or funder form.
Clinical Trial Protocol Synopsis Generator
Free protocol synopsis generator: fill in title, design, endpoints and criteria and get a structured, copyable…
Learn moreSPIRIT Protocol Checklist
Interactive SPIRIT 2013 checklist: mark each of the 33 items addressed, partial or not yet, track progress and copy or…
Learn moreUse Case
A cycle study is a longitudinal diary: bleeding days, symptoms, ovulation test results and, often, a wearable temperature signal, tracked across several cycles per participant. Capture runs the daily phone diary, the clinic visits and the consent in one study. Build and test it free, no credit card.
Menstrual Cycle and Fertility Tracking Study Software
Run a menstrual cycle tracking research study: daily phone diaries, cycle-day logic, ovulation test results, wearable…
Learn moreClinical Trial Software for Women's Health Research
Clinical trial software for women's health research: cycle, pregnancy, postpartum and menopause studies with phone…
Learn moreUse Case
A microbiome study is only as interpretable as its metadata. Antibiotics, diet, stool form, symptoms and exact sample timing all change the sequencing result. Capture records them next to the clinical outcome in one study with one audit trail. Test it free, no credit card.
Use Case
Going paperless does not mean buying an enterprise eClinical suite. For most sites the first win is the participant-facing paper: consent, case report forms and diaries. Capture covers those in one system with one audit trail, and you can rehearse the switch in the free sandbox before any participant is affected.
Sites Going Paperless: eRegulatory and eSource Lite
How a paperless clinical research site works: direct data entry, eConsent, ePRO and an audit trail replace paper CRFs.…
Learn moreRegenerative Medicine and Cell Therapy Site Studies
Regenerative medicine clinical study software: record product preparation, injection details, follow-up outcomes and…
Learn moreeSource Software for Clinical Sites
eSource software for sites: enter observations straight into the eCRF or ePRO, no paper source, with per-field SDV and…
Learn moreSwitching CROs or Bringing a Trial In-House: Data Migration
Clinical trial data migration when switching CRO or going in-house: what to demand, how to cut over, what to archive,…
Learn moreCross-Site Data Harmonization for Multi-Site Trials
Multi-site clinical trial data harmonization at entry: locked approved forms, edit checks, calculated fields,…
Learn moreUse Case
Your visit runs on video; the data still has to be captured, signed and audited. Capture handles remote consent, phone questionnaires and clinician-entered forms in one study. It is not a video platform, and says so.
Comparisons & evaluation
REDCap handles many multi-site projects well. The strain shows when sites sit in different institutions, countries and regulatory expectations, and one host has to govern all of them. Here is how to judge that, and what to look at instead.
REDCap Alternatives for Multi-Site Trials
REDCap alternatives for multi-site trials: when one institution-hosted instance strains across sites. DAGs vs site…
Learn moreREDCap Hosting and Validation Burden
REDCap validation burden: who validates, how release cadence drives re-validation, external modules, hosting duties,…
Learn moreFeatures
Consent that a participant signs but did not understand is not informed. This guide covers how to write, present and check consent for people with low literacy or accessibility needs, what IRBs expect, and, plainly, which parts Capture eConsent supports and which it does not.
Education
NIH expects a short Data Management and Sharing Plan with most applications that generate scientific data. This guide walks through the six elements, gives a worked outline for a demo clinical study, and flags what reviewers and program officers tend to look for.
NIH Data Management and Sharing Plan: Template and Guide
Write an NIH Data Management and Sharing Plan element by element, with a worked outline for a clinical study, a…
Learn moreClinical Data Cleaning: A Practical Guide
Clinical data cleaning explained step by step: edit checks, manual review, queries, reconciliation and database lock…
Learn moreBest CTMS for Small Clinical Studies: How to Choose
Choosing a CTMS for a small clinical study: when you need one, the options from spreadsheet to full suite, a selection…
Learn moreClinical Data Management Process: Setup to Database Lock
The clinical data management process step by step: data management plan, CRF design, database build, UAT, cleaning,…
Learn moreClinical Trial Lifecycle: From Idea to Close-Out
The clinical trial lifecycle from concept to close-out: design, approvals, start-up, conduct, data cleaning, lock,…
Learn moreDatabase Lock Checklist for Clinical Trials
A working database lock checklist for clinical trials: pre-lock data, queries, reconciliation and sign-off steps with…
Learn moreEducation
Validation is the sponsor's responsibility even when the vendor supplies the software. This checklist follows the lifecycle in the order a small team actually does the work: assess, plan, configure, test, release, and keep it controlled.
Education
Completion guidelines tell site staff exactly how to fill in each form so two coordinators enter the same facts the same way. This guide gives you a structure to copy, field-level wording for a demo study, and a rollout plan that gets the document read.
Education
The database is only one of the things a trial has to keep. FDA, ICH GCP, the EU Clinical Trials Regulation and national rules each set their own clock, and the longest one usually wins. This guide lays the clocks side by side and ends with an archive package you can build before the last visit.
Clinical Trial Data Archiving and Retention Requirements
Clinical trial data retention requirements: FDA, ICH GCP, EU CTR 25-year archiving and UK rules compared, plus a…
Learn moreEConsent Regulations Guide (FDA, EMA, HHS)
eConsent regulations explained: FDA Parts 50 and 11 and the eIC Q&A, HHS Common Rule, EU CTR and EMA, with a…
Learn moreEU CTIS Submission Guide: Clinical Trials Information System
CTIS, the EU Clinical Trials Information System, explained: who uses it, what Part I and Part II contain, the trial…
Learn moreRisk-Based Quality Management in Clinical Trials (ICH E6(R3))
Risk-based quality management in clinical trials under ICH E6(R3): critical-to-quality factors, risk assessment,…
Learn moreSAE Reporting Timelines by Region (FDA, EMA, MHRA)
SAE reporting timelines compared across FDA, EU CTR and UK MHRA: who reports to whom, the 24-hour, 7-day and 15-day…
Learn moreHow to Get IRB Approval: Step-by-Step
How to get IRB approval for a research study: choose the review level, prepare the package, respond to stipulations,…
Learn moreEducation
Most failed EDC implementations are not caused by software. They come from a build started on a draft protocol, a paper CRF copied screen for screen, edit checks nobody tested and sites trained the day before enrolment. Here are twelve mistakes, what they look like and the fix.
Common EDC Implementation Mistakes
EDC implementation mistakes that cause late queries, change orders and failed go-lives, with the signs, the cost and a…
Learn moreEDC Go-Live Checklist
EDC go-live checklist: build, access, site readiness, consent, safety and cut-over checks, plus go/no-go criteria and…
Learn moreEducation
A questionnaire tells you what a vendor says. An audit tests whether it is true. This checklist covers scope, the documents to request, questions by area, red flags and how to grade findings, for a sponsor, QA lead or small team auditing an EDC supplier.
EDC Vendor Audit Checklist
EDC vendor audit checklist for sponsors: scope, documents to request, questions by area, red flags and how to grade…
Learn moreEDC User Requirements Specification (URS) Template
A free EDC user requirements specification template: ready-to-adapt requirement IDs, priorities and test links for…
Learn moreEducation
A sponsor-investigator initiates a study and personally conducts it. That makes you responsible for the duties of a sponsor and of an investigator at once. This guide explains the role, the duties under FDA rules, who should and should not take it on, and the steps to get set up. General information, not legal advice.
How to Become a Sponsor-Investigator
Sponsor-investigator responsibilities explained: the dual role under FDA rules, what you must file, monitor and keep,…
Learn moreHow to Set Up a Trial Master File (TMF)
How to set up a trial master file: choose a structure, assign ownership, file as you go, run quality checks and…
Learn moreEducation
Blinding keeps knowledge of the assigned treatment from the people who could be biased by it. Doing it well means deciding who to mask, making treatments look alike, separating unblinded staff, planning emergency unblinding and checking afterwards. This guide covers each, including the data-system side that often leaks.
Education
A statistical analysis plan (SAP) turns the protocol's one-page statistics section into instructions someone else could follow without asking you. This guide walks through what goes in, in what order, how to handle estimands, populations and missing data, and the point at which the plan must be locked.
How to Write a Statistical Analysis Plan
How to write a statistical analysis plan for a clinical trial: section-by-section outline, estimands, populations,…
Learn moreHow to Randomize Participants (With and Without Software)
How to randomize patients without software: permuted blocks, sealed envelopes and who holds the list. Learn the risks…
Learn moreEducation
The three labels describe where trial activities happen, not how good the science is. This page compares them activity by activity, shows what each one asks of your data system, and ends with a short method for choosing a model for your own protocol.
Decentralized vs Hybrid vs Traditional Trials
Decentralized vs hybrid vs traditional trials compared: what happens where, who it suits, risks and software needs,…
Learn moreeConsent vs Paper Consent
eConsent vs paper consent compared on workflow, errors, evidence, remote use and cost. See where each wins and how to…
Learn moreCompliance & Regulatory
The EHDS Regulation sets new EU rules for how health data is accessed by patients and reused for research. Most of it applies in stages up to 2031. This guide explains the structure, the dates to watch and how to prepare your trial data now. Not legal advice.
European Health Data Space (EHDS) for Clinical Researchers
The European Health Data Space explained for clinical research: primary and secondary use, health data access bodies,…
Learn moreHealth Canada Clinical Trial Application (CTA) Guide
How a Health Canada clinical trial application works: what a CTA contains, the 30-day default review, the No Objection…
Learn moreICH E20 Adaptive Designs Guide
ICH E20 on adaptive designs explained: draft status, what adaptive trials are, the principles regulators care about…
Learn more21 CFR Part 312 (IND Regulations) Explained
21 CFR Part 312 explained: the IND regulation subparts, sponsor and investigator duties, 312.32 safety reporting…
Learn moreEducation
eCOA (electronic clinical outcome assessment) is the umbrella for every outcome measure collected electronically: reported by the patient, a clinician, an observer, or built from a task the patient performs. ePRO is the first of those, the part the patient reports directly. Most trials that say they need eCOA mean ePRO plus some site-rated scales.
eCOA vs ePRO: What Is the Difference?
eCOA vs ePRO: ePRO is one part of eCOA. See the four outcome assessment types, a side-by-side table and how to decide…
Learn moreEDC vs EHR for Research Data
EDC vs EHR: an EHR records patient care; an EDC captures protocol-defined trial data with edit checks and audit trail.…
Learn moreEDC vs eSource
EDC vs eSource: EDC is the system that holds trial data; eSource describes data first recorded electronically. See the…
Learn moreePRO vs Paper Diaries
ePRO vs paper diaries in clinical trials: how timing, missing data, cost and burden compare, with a decision guide and…
Learn moreSurvey Tools vs EDC
Survey tools vs EDC: five controls a survey tool lacks for clinical trial data (audit trail, edit checks, queries,…
Learn moreIRT vs RTSM
IRT vs RTSM explained: how IRT, IWRS, IVRS and RTSM relate, randomization vs supply management, and when EDC with…
Learn moreCompliance & Regulatory
Capture is ISO 27001 certified. This page explains what that certificate does and does not tell you about an EDC, and the controls to check in the product itself before you shortlist.
ISO 27001 Clinical Trial Software
ISO 27001 clinical trial software: Capture is ISO 27001 certified. What the certificate covers, what it does not, and…
Learn moreMulti-Factor Authentication in EDC
EDC multi factor authentication: staff turn on two-factor sign-in with any authenticator app. What it covers, what…
Learn moreLocations
A small team with a first-in-human study to open does not need a six-month EDC procurement. Capture is a self-serve EDC hosted in Frankfurt that you can build and test free before the first dose.