In one of the densest biotech clusters in the world, a seed or Series A team with a first-in-human study and five employees does not need an enterprise EDC contract. Capture is a self-serve EDC, ePRO and eConsent platform you can build and test free, then pay for once participants are enrolled.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Boston and Cambridge, Massachusetts
Key points for Boston and Cambridge biotech
The cluster
The Boston-Cambridge area is home to a large concentration of biotech companies, university labs and teaching hospitals within a few miles. Many companies there are venture-backed, run to a milestone and move a lead asset from IND to first-in-human fast. They tend to run the first study at one to a handful of academic or Phase 1 sites, often with a CRO for monitoring, and need a data system that the clinical lead can configure over a few days.
That is a different buyer from a large pharma sponsor. The needs are specific: forms for demographics, vitals, ECG, labs, adverse events and concomitant medications ready quickly, dose escalation and cohort tracking, safety review in near real time, a clean audit trail for the IND, and a cost that does not require a multi-year commitment. The more specific guides are EDC for first-in-human studies, EDC for Phase 1 clinical trials and clinical trial software for early-phase trials.
Upload protocol
PDF, DOCX or DOC
Describe it
Plain-language summary
Phase 1 template
8 visits, ready to edit
Fast start
Upload the protocol and the AI study builder drafts the visit schedule and forms for your review. Nothing is saved without a human check. Use the template library for the standard safety forms, add edit checks and calculated fields such as QTcF and eGFR, and run the whole study with sample data before the site initiation visit.
Question form
CRF or ePRO
Lab table
Analytes, units, ranges
1. Systolic blood pressure
Required · Number · mmHg · 0 dp
2. Diastolic blood pressure
Required · Number · mmHg · 0 dp
3. Pulse rate
Required · Number · beats/min
4. Body temperature
Required · Number · °C · 1 dp
5. Position during measurement
Required · Sitting, Supine, Standing
The free sandbox has every feature, with no credit card and no time limit. Show your CRO the real thing.
Regulatory
For an IND study, the sponsor is responsible for ensuring that electronic systems used for trial records are fit for purpose. Capture provides the building blocks: a field-level audit trail with timestamp, user identity, old value, new value and reason for change that cannot be modified in the UI; electronic signatures with re-authentication; role-based access with blinding where needed; and a draft-to-approved form lifecycle that locks forms for live use. The checklist for those controls is in the 21 CFR Part 11 compliance checklist, and the questions an inspector tends to ask are in the FDA inspection checklist.
On the IRB side, the blank eCRF PDF export (cover page, form index, visit-by-form matrix and every approved form printed empty) is a handy attachment for the submission, and consent documents export as signed PDFs with embedded signature data. Most academic medical centres in the area have their own requirements for reliance on a central IRB, so plan that conversation early. For the HIPAA side, read HIPAA compliant clinical trial software; Capture describes its infrastructure as HIPAA-ready.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Fit
| Need | Typical enterprise path | With Capture |
|---|---|---|
| Getting started | Sales cycle, contract, vendor-built study | Sign up, build yourself, test free |
| Time to a tested study | Vendor-built, often weeks | Faster, with AI drafting and templates |
| Commitment | Multi-year contract is common | Free sandbox; pay once you go live |
| Add ePRO, eConsent | Often separate vendors | Same platform, same audit trail |
| CRO involvement | Often required for build | Optional; your CRO can work in the same study |
Illustrative of common patterns, not a statement about any named vendor.
Before you start
Central or single IRB versus site IRBs, and the reliance agreements each site needs.
Visits, forms and edit checks, reviewed and approved by the clinical lead.
How cohort and dose decisions will be documented in forms and roles, agreed with your medical monitor.
Audit trail, signatures and access control documented in your validation file.
CSV, Excel, or SDTM as SAS XPT with Define-XML for your statisticians.
Roles set up so monitors see what they need and nothing else.
Yes. It is built for Phase 1 through Phase 3 studies, with safety forms, edit checks, audit trail and e-signatures. See the first-in-human guide for the detail.
Capture provides Part 11-aligned controls: a field-level audit trail, electronic signatures, role-based access and a locked form lifecycle. Compliance is a shared responsibility with your own validated use, so keep your validation file.
In the USA (N. Virginia), with AES-256 encryption at rest and TLS in transit. Capture also hosts in the EU (Frankfurt) for studies with European sites.
Not to use Capture. The platform is self-serve. You can still add a CRO, and monitors can work in the same study with their own roles.
Yes. CSV and Excel exports with an automatic data dictionary, and CDISC SDTM datasets as SAS XPT files with Define-XML.
Yes. The sandbox has every feature with no credit card and no time limit. You pay once you go live with real participants.
Keep exploring
EDC for first-in-human studies
Dose escalation and safety.
EDC for Phase 1 clinical trials
Early-phase detail.
Clinical trial software for small biotech
Lean team fit.
Clinical trial software without a CRO
Self-serve set-up.
21 CFR Part 11 checklist
The controls in detail.
HIPAA compliant trial software
US privacy.
Build it, test it and show your CRO, all free. Pay once you go live.