What we do

Clinical services

  • Planning and Managing Clinical Trials (Phase I-IV)
  • Preparation of Clinical Trial Synopses and Protocols
  • Contract preparation, evaluation of proposals from CROs and laboratories
  • Review of Case Report Forms
  • Evaluation and conclusion on clinical trial results
  • Preparation of Clinical Trial Reports, Posters and Publications
  • Preparation of clinical development plans, Investigator’s Brochure and other project related documents
  • Assisting in preparing clinical trial applications in Europe (CTAs) and US (INDs)
  • Assisting in preparing the Common Technical Document (CTD) and the Clinical Overview of the CTD
  • Assisting in Q&As on RA filings
  • Preparation for GCP audits and inspections
  • Surveillance of relevant regulations and guidelines with special focus on GCP

Trial Supply Management

  • Clinical Trial Supply Management and Co-ordination (Phase I – IV), including preparation of master labels, directions for use, creation of packaging designs, shipments, returns and destruction
  • Purchase of comparators
  • Preparation, update and follow-up on trial supply budgets
  • Management of resources and capacity including needed outsourcing activities in relation to co-ordination, labeling, packaging and distribution of trial supplies
  • Mapping of competencies and streamlining of work processes
  • Setting up specifications and procedures and understanding customer needs in order to work proactively with clinical trial supply
  • Participate in GMP audits and inspections
  • Surveillance of relevant regulations and guidelines with special focus on GMP, Annex 13 and the interface to GCP

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