Clinical Trials
Keep every site on protocol and every participant in follow-up, with data that stands up to regulatory review, online or offline.
The Challenge
Trial teams manage participants, protocols, and data across many sites, where small gaps carry real risk.
Informed consent and privacy
Participant consent must be captured and kept secure.
Audit trails for regulators
Every entry needs a traceable, reviewable record.
Retaining participants over time
Follow-up visits stretch across months or years.
CommCare for Clinical Trials
Consent and enroll participants correctly, from the very first visit
- Eligibility logic enforced in the form, so ineligible participants never enroll
- Digital signatures time-stamped for the audit record
- Randomization assigned automatically at enrollment, no manual step to get wrong
- Participant IDs generated fully offline at remote sites
Keep every site on protocol, whoever collects the data
- Locked protocol versions keep every site on the approved forms
- Range validation catches errors at entry, not months later at data cleaning
- Multiple entries per participant per visit, still one clean record
- Surveyor-led, SMS, and online collection flow into the same dataset
- Immutable audit trail with reason-for-change, ready for regulators
Catch enrollment gaps and data issues while you can still fix them
- Enrollment visible per site and in aggregate, so lagging sites surface early
- Overdue-visit alerts help teams keep participants through years of follow-up
- Field-level data queries raised and resolved in one place, not over email
- Data flows on to 21 CFR-compliant electronic data capture systems, IQVIA-compatible
Get from last visit to publication without months of data cleaning
- Investigator dashboards keep every site and the full study in view
- De-identified exports go straight to analysis and publication
- Power BI, Excel, and SQL connections built in, no re-entry
- Full audit trail exports ready for regulatory review
Want to see how this would work for your next trial?
Talk to our teamClinical trial programs, powered by CommCare
Sickle cell newborn screening across 7 African countries
Used by Novartis and the American Society of Hematology's Consortium on Newborn Screening in Africa (CONSA) to document and coordinate diagnosis of babies with sickle cell disease, with case data integrating directly into IQVIA via API.
Read the story
Pharmacokinetic Trial, Nairobi, Kenya
CommCare supported a PK trial with KEMRI requiring multiple data entries per patient per day, integrated directly into a 21 CFR-compliant EDC system.
Read the case study →
Azithromycin MDA Trial, 1,150 Villages, Mali
Data collection covering 35,000 infants across 1,150 Malian villages, enabling real-time mortality and antibiotic resistance analysis.
Read the case study →
MAHAY Cluster-Randomized Trial, Madagascar
A cluster-randomized trial in rural Madagascar tested whether adding early-childhood-development stimulation to nutrition programs improves child outcomes, captured on CommCare.
Read the case study →One clinical-trials engine, built for every sector.
Use the power of CommCare to configure for any kind of clinical trial, in any sector.
Randomized and observational studies, in any domain.
From infectious-disease screening to maternal cohorts to agricultural RCTs, the same platform powers trials across every sector CommCare serves. Pick a sector to see how it tunes.
- GxP-aligned data capture with audit trails
- eConsent and protocol-driven visit logic
- Investigator dashboards across sites
Clinical Trials FAQs
Compliance & Integrations
Can CommCare integrate with 21 CFR-compliant EDC systems?
Yes. CommCare integrates with validated EDC systems via API, with data auto-forwarded and de-identified at transfer, validated in production on a pharmacokinetic trial with KEMRI in Nairobi. Dimagi can document the integration architecture for your validation requirements.
What security certifications does CommCare hold?
CommCare (CommCare HQ) is SOC 2 Type II certified, the only Global Good platform to hold this certification. It is also HIPAA-eligible, with Business Associate Agreements (BAAs) for studies handling protected health information, and data residency options for jurisdiction-specific requirements.
What data export and integration options are available?
CommCare exports to CSV, Excel, Power BI, and SQL databases, plus OData feeds and third-party APIs for IQVIA, Medidata, REDCap, and other research data systems. The full audit trail is exportable separately for regulatory submissions.
Trial Operations
Can CommCare work at sites with no or limited internet?
Yes. CommCare is built offline-first: data is captured on the device and syncs when connectivity is available. That suits remote field sites, community clinics, and decentralized trial models, and is a key reason research institutions choose CommCare over web-based EDC tools in low- and middle-income countries.
Does CommCare support randomization?
Yes. Randomization logic can be built into the eligibility and enrollment form, assigning participants to trial arms automatically at consent. The randomization event and arm assignment are recorded in the audit trail.
How does CommCare handle protocol amendments mid-study?
CommCare supports versioned form deployments: when a protocol is amended, you deploy the new form version to the relevant sites. Data collected under the prior version is preserved, and the form version used for each submission is logged in the audit trail.