OpenClinica
8.1#1 in research administration softwareFrom $750 a monthAndroidiOSWebAPI
VisitOpenClinica vs SimplerQMS
SimplerQMS
6.7#5 in life sciences softwareFrom $17,500 a yearFree planWebAPI
VisitWhat both publish
| Fact | OpenClinica | SimplerQMS |
|---|---|---|
| Compliance | The company states its platform is ICH GCP E6 (R2), 21 CFR Part 11, HIPAA, and GDPR compliant, and SOC 2 Type II and ISO 27001 certified. | The company says SimplerQMS A/S is ISO 13485:2016 and ISO/IEC 27001:2022 certified, and that its software complies with FDA 21 CFR Part 11. |
| Headquarters | Needham, Massachusetts, USA | Copenhagen, Denmark |
| Intended users | The company says it focuses on small to midsize sponsors, CROs, and academic research teams. | The product is intended for life science organizations, including medical device, pharmaceutical and biotech, laboratory, and CRO/CMO companies. |
OpenClinica plans
- Launch$750 a month
- Core$3,000 a month
- Advanced$3,750 a month
- Enterprise & AcademicPriced on request
SimplerQMS plans
- Viewer licenseFree
- Starter$17,500 a year
- Team & EnterprisePriced on request
Pick OpenClinica if…
OpenClinica is aimed at small to midsize sponsors, CROs, and academic research teams. Its mix of EDC and related clinical-study modules may suit teams needing study data capture and connected workflows.
Pick SimplerQMS if…
SimplerQMS suits life science organizations, including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO companies. Its modules cover quality processes such as document control, audits, CAPA, and supplier management.