Purpose-built clinical trial management systems are designed for the most complex end of clinical research: multi-site pharmaceutical trials with regulatory submission requirements, complex randomization protocols, and enterprise IT integration. They’re built for buyers that aren’t smaller academic research teams, hospital research departments, or independent investigators running focused studies.The result is a market gap that most smaller research teams navigate with spreadsheets, shared drives, and REDCap. These solutions work up to a point, but they create friction at the edges: HIPAA compliance, multi-user access control, integration with clinical workflows, and reporting that doesn’t require manual data assembly.
What Smaller Studies Actually Need
A research team running a 200-participant observational study doesn’t need the full infrastructure of a Phase III clinical trial management system. What they actually need is:
A secure, multi-user database for participant records
Digital enrollment and consent forms that feed records directly
Visit and assessment tracking linked to participant records
Role-based access so research assistants, coordinators, and PIs see appropriate data
HIPAA-compliant hosting with a signed BAA for studies involving health information
Reporting that pulls from the database for interim analyses and IRB reports
This is a database problem, not a clinical trial platform problem.
How Knack Health Fits Research Teams
Knack Health lets you build a research database configured to your study protocol. Participant enrollment records contain the consent and eligibility fields your IRB requires. Visit records are linked to participants and contain the assessment fields for each visit type. Adverse event records are linked to participants and visits. PIs and data managers have access to the full dataset. Research assistants see only the participants they’re assigned to.See Knack Health for healthcare research. →HIPAA plans start at $625 per month, flat-rate. No per-user fees, so adding research assistants, coordinators, or data managers doesn’t change your cost.
The REDCap Comparison
REDCap is the dominant tool for this use case in academic research settings. It’s free for institutions with a REDCap license, which covers most university-affiliated researchers. For research teams outside that institutional context — or those who need more flexible data modeling and external participant access — Knack Health is worth considering.
Build your study database on Knack HealthKnack Health gives research teams a HIPAA-compliant database configured to their protocol — participant records, digital consent, visit tracking, outcome measures, and IRB reporting. No per-user fees. No custom development.Talk to us. →
Does Knack Health meet 21 CFR Part 11 requirements for FDA-regulated studies?
21 CFR Part 11 applies to electronic records and signatures in FDA-regulated studies and requires specific audit trail, electronic signature, and system validation capabilities. For FDA-regulated studies, confirm Part 11 compliance with the Knack Health team before selecting the platform. For observational studies and IRB-approved research not subject to FDA oversight, Part 11 typically doesn’t apply.Contact Knack Health about research use cases. →
How do we handle informed consent documentation?
Digital consent can be collected through a form in Knack Health, with the participant’s acknowledgment and submission date recorded as part of their record. For studies requiring wet signatures, scanned consent forms can be attached to the participant record.
What happens to our data if we need to migrate?
Data stored in Knack Health is exportable in standard formats including CSV. For research data with long-term retention requirements, confirm the export format with your compliance officer before starting data collection.
Can we give participants a portal to access their own data?
Yes. A participant-facing portal can be built in Knack Health with role-based access showing each participant their own record, upcoming visit schedule, and any participant-appropriate information from their study data.
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