Clinical Development

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

- Dr. Andrea Niese Head of Medical & Preclinical

Clinical Development

The clinical development team is an international group of experienced professionals trained in clinical medicine and research, (molecular) biology, and pharmaceutical sciences. Their extensive scientific experience in industry and academia will bring your clinical development projects to success. The team offers hands-on support with in-depth consultancy and medical writing:

  • Clinical development planning
  • Consultation with regulatory authorities for scientific advice
  • Briefing documentation for scientific advice procedures
  • 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
  • Dossier preparation (CTD)
  • Product Information texts
  • Handling of assessment reports
  • Pediatric investigational plans
  • Orphan drug designations
  • Protocol assistance for orphan drugs
  • Systematic literature searches
  • Clinical evaluation of medical devices
  • Scientific justification for reclassification of products (Rx- and OTC-Switch)
  • Biowaiver justification
  • Risk management plans
  • 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

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