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ClinFocus

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ClinFocus

ClinFocus is a data-first CRO specializing in clinical data management, biostatistics, and AI-enabled analytics for clinical trials, Early Access Programs, and Real-World Evidence studies. As a Medidata-accredited partner, we prioritize data integrity, speed, and regulatory compliance from protocol design through database lock.

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Locations

  • APAC
  • Europe
  • North America
  • South America
Overview Accreditations / Enablement

Therapeutic Areas

  • Bone / Osteoporosis
  • Cardiovascular
  • CNS
  • Dermatology
  • Devices and Diagnostics
  • Diabetes
  • Gastroenterology
  • Genetic Diseases
  • Neurology
  • Oncology
  • Respiratory
  • Rheumatology
  • Sleep
  • Vaccines

ClinFocus is a biometrics-focused, data-first Contract Research Organization built to support modern clinical development with precision, speed, and regulatory rigor. We specialize in Clinical Data Management, Biostatistics, Statistical Programming, and AI-enabled data analytics across interventional clinical trials, Early Access Programs (EAP), registries, and Real-World Evidence (RWE) studies.

Our philosophy is simple: better data drives better decisions. From protocol review and CRF design to database build, validation, and database lock, we structure every engagement around data quality, traceability, and inspection readiness. As a Medidata-accredited partner, our teams have deep expertise in Medidata Rave EDC, RTSM/IRT integrations, data integrations, reconciliation workflows, and global study deployments.

ClinFocus combines strong GCP and ICH E6(R3) compliance foundations with advanced analytics capabilities. We leverage AI-driven data review, risk-based quality oversight, and automated consistency checks to accelerate study timelines while maintaining audit-ready documentation standards.

Our approach reduces query cycles, improves site performance visibility, and enhances sponsor decision-making. We support biotech, pharmaceutical, and emerging sponsors seeking scalable biometrics leadership without the overhead of traditional full-service CRO structures.

Whether supporting oncology trials, hybrid RWD designs, or global multi-site studies, ClinFocus delivers structured governance, transparent reporting, and measurable performance metrics. At ClinFocus, data is not an output of the trial. It is the foundation of the trial.

Accreditations / Enablement

Partners are trained on the functionality of the Coder application, process optimization, and scope of Coder services. This Accreditation teaches Partners to integrate the medical coding solution with EDC studies and administer Coder segments. Coder Accreditation is dependent on the successful completion of the Rave EDC accreditation.
Partners are trained on the functionality of the electronic data capture (EDC) and clinical data management (CDM) system, process optimization exercises and scope of Medidata Rave services. This Accreditation teaches the staff to perform end user training, user and site administration, study build, reporting, outputs and amendment manager.
Partners are trained on the functionality of the targeted source document verification (TSDV) application, process optimization, and scope of TSDV services. This Accreditation teaches Partners to implement TSDV in line with regulatory compliance and data quality strategies. TSDV Accreditation is dependent on the successful completion of the Rave EDC Accreditation.