A good request for proposal gets comparable answers from vendors and exposes the differences that matter. Here is a structure for an EDC RFP, the requirements to include, the questions that reveal the most, and how to score the answers.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Background and study overview
Scope and modules
EDC, ePRO, eConsent, randomisation
Functional requirements
Compliance and validation
Security and hosting
Support and training
Pricing and commercial terms
Evaluation and timeline
The short version
Template
| Section | Content |
|---|---|
| Background | Organisation, therapeutic areas, typical study size and phases, countries |
| Scope | Modules needed: EDC, ePRO, eConsent, randomisation, supply, safety, integrations |
| Functional requirements | Form building, edit checks, queries, SDV, schedules, exports, reporting |
| Compliance and validation | Part 11 and Annex 11 controls, audit trail, e-signatures, validation documentation |
| Security and hosting | Hosting regions, encryption, access control, backups, incident response |
| Support and training | Support hours and response times, training, documentation |
| Commercial | Pricing model, example study quote, contract length, exit terms |
| Evaluation | Timeline, scoring criteria, demo and sandbox expectations |
Questions
Generic requirements ("Does the system have an audit trail?") get generic yeses. Specific questions get useful answers: "Show the audit trail entry when a site corrects a value after a query, including the reason." "Who builds and amends forms, and how long does a typical amendment take?" "What does a participant see when they open a diary on their own phone?" "What does it cost to add a site mid-study?"
Ask about exit as well as entry: in what formats can all data, audit trails and signed documents be exported at the end, and at what cost? See clinical trial data ownership and portability and the vendor security questionnaire.
Paper answers only go so far. Ask shortlisted vendors for sandbox access and have your data manager build one of your real forms with edit checks, a site coordinator enter data, and a monitor raise a query. The results are often more decisive than the written responses.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Scoring
| Area | Weight | How to score |
|---|---|---|
| Functional fit | 30% | Requirements met, weighted by importance; sandbox test results |
| Compliance and validation | 20% | Controls demonstrated; documentation provided |
| Usability | 15% | Hands-on testing by data manager, coordinator and monitor |
| Security and hosting | 10% | Security questionnaire, hosting regions |
| Support | 10% | Response times, training, references |
| Total cost | 15% | Example study quote including change orders |
Adjust weights to your priorities and agree them before responses arrive.
Capture
Capture's free sandbox has every feature with sample data and no time limit, so your team can test it against your RFP requirements before any sales conversation. Upload a protocol, build a form, break an edit check, sign a test consent and export the data.
Upload protocol
PDF, DOCX or DOC
Describe it
Plain-language summary
Phase 1 template
8 visits, ready to edit
No credit card, no sales call required.
Before sending
Example study with size, countries and modules.
With a fixed response format.
Specific "show me" questions, not yes or no.
Total cost for a defined study.
Export formats and costs at end of contract.
Weights set before responses arrive.
Supported, configurable, roadmap or not supported, with space for explanation and evidence.
Yes, from customers with similar study types and sizes.
Background, scope, functional requirements, compliance and validation, security and hosting, support, commercial terms and evaluation criteria.
Usually three to six. Shortlist two or three for demos and hands-on testing.
Ask for total cost for a defined example study, including set-up, licences, per-site and per-participant fees and change orders.
Yes. Sandbox testing by your own team is often more revealing than written answers.
Ask how all data, audit trails and signed documents can be exported at the end of the contract, and at what cost.
Yes. The free sandbox has every feature, with no credit card and no time limit.