Our services include:

  • Study Management
  • Biostatistics
  • Study Monitoring
  • Data Management
  • Regulatory Support
  • IVDR Readiness Consultation

Study Management

Our experienced study managers design, plan and coordinate according to your requirements to ensure the success of analytical and clinical performance studies


Expert biostatistics consultation including statistical analysis planning, case number calculation, data analysis, and reporting.

Study Monitoring

Our team of Clinical Research Associates manages study sites and documentation for full compliance (monitoring plan, TMF, SAV, SIV, SDV, COV).

Data Management

Complete data management including data management plan, eCRF set-up and management, and database management.

Regulatory Support

We take care of study related submissions to ethics committees/institutional review boards and national competent authorities, as well as technical meetings, e.g., with notified bodies (EU), BfArM/PEI (Germany), FDA (Pre-Sub).

IVDR Readiness Consultation

Classification of products and IVDR gap analysis of technical documentation. Project management coordinating development partners and the liaison with regulatory authorities.