Compliance & 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 moreICH 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 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 moreEU 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 more21 CFR Part 11 Compliant EDC
The Part 11 controls built into Capture: re-authenticated e-signatures, a tamper-evident audit trail, server…
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 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 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FDA's January 2026 draft guidance sets out how it expects Bayesian trial designs to be built.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 moreFDA Inspection Checklist for Clinical Trial Data
FDA BIMO inspection checklist for clinical trial data: what inspectors review at sites and sponsors, audit trails,…
Learn moreHIPAA vs GDPR for Clinical Trial Data
HIPAA vs GDPR for clinical research: who each applies to, legal bases, de-identification versus pseudonymisation,…
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 moreClinical 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 moreISO 14155 Clinical Investigation Software
What ISO 14155 means for data systems in medical device clinical investigations: data management expectations, adverse…
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