Our services include:

  • STUDY DESIGN, INCL. LITERATURE RESEARCH
  • STUDY PREPARATION
  • RISK-BASED PLANNING AND MONITORING OF PROCESSES IN ALL PROJECT PHASES
  • PREPARATION OF THE STUDY PROTOCOLS (CPSP, APSP)
  • SELECTION OF APPROPRIATE STUDY SITES
  • PREPARATION OF ALL ESSENTIAL DOCUMENTS, E.G. INVESTIGATOR CONTRACTS, PATIENT INFORMATION AND CONSENT FORMS, CASE REPORT FORMS (CRF),
  • COMPILATION OF DOCUMENTATION, APPLICATION AND SUBMISSION TO THE RELEVANT NATIONAL AND INTERNATIONAL AUTHORITIES AND ETHICS COMMITTEES
  • CROSS-FUNCTIONAL COORDINATION OF THE STUDY TEAMS
  • ORGANISATION OF THE SCIENTIFIC ADVICE WITH THE AUTHORITIES OR NOTIFIED BODY
  • 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

Study Monitoring

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

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 / CFR Readiness Consultation

We check for you the classification of your products and perform an IVDR gap analysis of the technical documentation for products with an IVDD CE-mark. For existing data and identified gaps, we develop for you strategies and solutions, so that your products are also fir for the new IVDR. Furthermore, we support you with the market access in the U.S. and the fulfillment of the FDA-requirements (according to CFR) via provision of the necessary steps and development of the best solutions.