Clinical Development

WE DEVELOP TAILOR-MADE SOLUTIONS FOR YOUR DEVELOPMENT PROJECTS THROUGHOUT THE CLINICAL STAGES OF ITS LIFE CYCLE.

- Dr. Andrea Niese Head of Medical & Pre-clinical, Physician

Clinical Development

The clinical development team is an international group of experienced professionals trained in clinical medicine and research, biology, and pharmaceutical sciences. Their extensive scientific and hands-on experience in industry and academia will bring your clinical development projects to success and offer practical support with:

  • Clinical development planning
  • Dossier preparation (CTD)
  • Consultation with regulatory authorities for scientific advice
  • Briefing documentation for scientific advice procedures
  • Protocol assistance for orphan drugs
  • Product Information texts
  • Risk management plans
  • Handling of assessment reports
  • Pediatric investigational plans
  • Orphan drug designations
  • Clinical trial planning, management, and evaluation and interpretation of results
  • Compilation, maintenance, and storage of clinical trial masterfiles
  • Investigator´s brochures
  • Investigational medicinal product dossiers
  • Systematic literature searches
  • Scientific justification for reclassification of products (Rx- and OTC-Switch)
  • Biowaiver justification
  • PSURs
  • DSURs
  • Feasibility assessments and gap analysis for project assessments
  • Due diligence for in-Licensing candidates
  • Identification of qualified service partners, key opinion leaders and scientific experts
  • Clinical evaluation of medical devices
  • Medical Writing

Have a question concerning Clinical development? Contact Dr. Andrea Niese.