Our consultancy & services include the following areas:

Diagnostic Clinical Trial Management

  • Clinical and medical affairs expertise, especially in oncology (preclinical, clinical phase I-III)
  • Assessment of the clinical validity and patient’s benefit of biomarkers
  • Intended use statements, clinical utility, medical risk assessment, clinical development plan of IVD
  • Setup and performance of clinical exploratory and validation studies (retrospective/prospective)

Life Cycle Management of IVD devices

  • Establishment of SOPs and technical documentation including Performance Evaluation Plan, Scientific Validity Report, Performance Evaluation Report, and literature search and appraisal
  • Application and CE registration/IVDR submission
  • IVDR readiness for self-declared legacy products
  • Post market surveillance, vigilance and post market clinical registry trials, Post Market Performance/ Clinical Follow-up (PMPF, PMCF)

Clinical Trial Liaison

  • Support successful execution of clinical trials through close interaction with study sites to increase awareness and visibility in Europe
  • Develop, maintain and manage relationships with key opinion leaders and national coordinators
  • Ensure appropriate understanding of the study protocol and the drug’s mechanism of action by all involved study personnel
  • Identify barriers of enrollment and develop strategies recommendation of solutions to overcome these barriers site and country-specific

Medical affairs

  • Provide support and response to medical questions within clinical trials
  • Consultancy for the establishment of clinical development plans
  • Create scientific training modules and materials
  • Writing of briefing packages to regulatory authorities such as FDA and EMA

Project management of oncology trials Phase 1-3

  • Consultancy for feasibility studies
  • Writing of study protocols and related documents
  • Operational project management

For more information please see our brochures:

Therawis Pharma has established a European-wide network with oncology specialists. We have a proven track record for improving patient enrolment through interaction with study sites and key opinion leaders (KOL) in the following countries: