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Clinical Development

 

Moving a small or large molecule from bench to bedside is a lengthy and resource intensive process that also comes with great risk. Products would never reach market without the expertise of clinical development professionals to address nonclinical and clinical strategy, medical / regulatory writing, and commercialization.

Just in time engagement

Why BioPoint?

BioPoint increases the value of your development projects by helping create optimal development plans while reporting practical assessments of data and regulatory requirements. Our interdisciplinary network of clinical development experts is available to support our clients at every phase of product development.

BioPoints justintime engagement model presents our Life Science customers with the flexibility to help them quickly address the critical staff augmentation and strategic consulting required to increase the value of their development programs.

We can provide a highimpact subject matter expert or a wellrounded team, working onsite or remotely, to help deliver tailored solutions.

Clinical Development Consulting Services

  • Clinical Development Strategy
  • Clinical Development Plans
  • Preparing Dossiers & Submissions
  • Understanding Current Standards of Care
  • Mapping Competitive Landscape Medical
  • Support for Agency Interactions
  • Developing Protocols
  • Developing Target Product Profiles
  • Regulatory Support GCP Compliance
  • Developing Clinical SOP’s
  • Medical Affairs (Pre and Post-Launch)
  • Pharmacovigilance Consultancy Medical Monitoring
  • Clinical Data Cleaning, Analysis, and Review
  • Clinical Development MD ad hoc Consulting
  • Clinical Research Scientist ad hoc Consulting