Our services include:

  • STUDY DESIGN, INCL. LITERATURE RESEARCH• STUDY PREPARATION
    RISK-BASED PLANNING AND MONITORING OF PROCESSES IN ALL PROJECT PHASES
  • PREPARATION OF PERFORMANCE STUDY PLAN
  • SELECTION OF APPROPRIATE STUDY SITES
  • PREPARATION OF INVESTIGATOR CONTRACTS, CASE REPORT FORMS (CRFS), PATIENT INFORMATION AND CONSENT FORMS
  • COMPILATION OF DOCUMENTATION, APPLICATION AND SUBMISSION TO THE RELEVANT NATIONAL AND INTERNATIONAL AUTHORITIES AND ETHICS COMMITTEES
  • CROSS-FUNCTIONAL COORDINATION OF THE STUDY TEAM
  • ORGANISATION OF SCIENTIFIC ADVICE
  • PREPARATION OF THE STUDY REPORT

Study Management

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

Biostatistics

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.