Clinical & CRO Services for Medical Devices and IVDs

End-to-end clinical evidence generation to support regulatory approvals and ongoing compliance under EU MDR, IVDR, US FDA, CDSCO, and global frameworks.

Bioexcel provides specialized

  • Clinical research (CRO).
  • Services exclusively for medical device.
  • In Vitro Diagnostic (IVD) manufacturers.

We support the complete clinical evidence lifecycle-from pre-market clinical investigations to post-market clinical follow-up (PMCF) and real-world evidence generation.

Our clinical activities are regulator-driven and inspection-focused, ensuring that all studies, reports, and datasets are suitable for Notified Body review, regulatory submissions, and audits.

WHAT WE SUPPORT

  • EU MDR & IVDR clinical evidence requirements
  • ISO 14155 and GCP-aligned clinical investigations
  • IVD performance and clinical performance studies
  • PMCF and post-market evidence strategies
  • Audit-ready clinical documentation

Clinical Investigations

Clinical Investigations (EU MDR / ISO 14155)

Planning and execution of clinical investigations including

  • CIP development
  • Ethics and regulatory submissions
  • Site management
  • Monitoring
  • Clinical study reporting

Clinical Evaluation Reports (CER)

Clinical Evaluation Reports (CER)

Preparation of MDR-aligned CERs integrating

  • Clinical data
  • Literature
  • PMS and PMCF evidence to demonstrate safety
  • Performance
  • Risk–benefit compliance

IVD Performance Evaluation

IVD Performance Evaluation (IVDR)

Support for scientific

  • Validity
  • Analytical Performance
  • Clinical Performance Studies
  • Including Performance Evaluation Plans
  • Reports (PER) under IVDR.

PMCF & PMS

PMCF & Post-Market Clinical Evidence

Design and execution of PMCF

  • Plans and Studies
  • Surveys and Registries
  • Real-World evidence collection
  • Integration into CER and PSUR

Biostatistics & Data Management

Support for scientific

  • Sample size calculations
  • Statistical Analysis Plans
  • Clinical Data Analysis
  • Regulatory-ready statistical reports supporting clinical and PMCF studies.

Medical Writing

Medical & Regulatory Writing

  • Clinical protocols
  • Investigator Brochures
  • Clinical Study Reports
  • Safety documentation aligned with global regulatory expectations.

DIGITAL ENABLEMENT (IMPORTANT FOR XCELTRIALS)

Digital Enablement of Clinical Studies

Clinical investigations, PMCF activities, and real-world evidence collection can be digitally managed using Xceltrials™, Bioexcel’s clinical trials and evidence management platform.

Xceltrials™ enables:

  • Structured clinical data capture
  • PMCF and RWE management
  • Audit-ready documentation and traceability

WHY BIOEXCEL FOR CLINICAL & CRO

  • Focused exclusively on Medical Devices & IVDs
  • MDR, IVDR, ISO 14155 and GCP-aligned processes
  • Regulator- and Notified Body-driven approach
  • Integration of services with digital compliance platforms

Plan Your Clinical Evidence Strategy with Confidence

Whether you are preparing for :

  • CE marking
  • IVDR compliance
  • Post-market obligations
  • Bioexcel helps you generate the right clinical evidence-the right way