Decentralized Clinical Trial Recruitment, Patient Matching & HIPAA Audit Vault
Advanced patient recruitment and data management platform for clinical trials, enhancing recruitment velocity, trial scalability, and regulatory compliance.
- Venture
- A Clinical Research Organization (CRO) & Life Sciences Network
- Industry
- Clinical Trials & Healthcare Operations
- Geography
- United States
What was in the way
A clinical research organization faced high drop-off and slow patient enrollment for multi-center clinical trials due to complex inclusion/exclusion criteria and legacy paper screening.
- 01Clinical trial recruitment delays cost sponsors millions per month in delayed drug launch timelines.
- 02Manual review of patient electronic health records for complex protocol eligibility was slow and prone to errors.
- 03Stringent FDA 21 CFR Part 11 and HIPAA compliance required tamper-evident digital audit logs for all patient interactions.
The architecture, and why
Developed a compliant patient recruitment and clinical trial management platform featuring automated protocol eligibility prescreening, digital e-consent, and immutable audit logs.
- Algorithmic clinical trial matching engine evaluating patient lab biomarkers and medical history against trial protocols.
- FDA 21 CFR Part 11 compliant digital informed consent (e-Consent) module with biometric signature capture.
- Real-time investigator site portal tracking patient enrollment pipelines across participating hospital centers.
- Encrypted patient communication pipeline providing automated appointment coordination and visit reminders.
What is running in production
What changed, measured
Ventures are described by industry and geography rather than by name, so publishing never waits on a client's sign-off. Named detail replaces a descriptor whenever an approval arrives. The numbers above are unchanged either way — our delivery record is independently verifiable on Upwork.
Whether it's co-founding a venture from a blank repo, embedding a senior pod, or automating the back office — bring us the architecture problem and we'll tell you honestly whether we're the right team for it.
- You talk to a senior architect, not an account manager
- 24-hour response on any scoped request
- Mutual NDA and IP assignment as standard