preclinical development

ClinDatrix offers preclinical development services to help emerging biomedical companies navigate the challenging product development pathway. The Preclinical Development Consortium (PDC) is a network of industry-experienced experts, led by Dr. Ned Whittemore, who offer expertise in the major technical functions involved in biomedical product development.

The ClinDatrix PDC business model is to be our clients’ virtual preclinical development department. Working with drug and medical device innovators, the PDC provides strategic preclinical program assessment, planning and management.

We will assemble the team of experts each client needs to advance their compounds or devices to a regulatory filing; conduct due diligence on a potential acquisition or licensing opportunity; investigate the patent or freedom to operate landscapes; or to achieve other similar preclinical goals. Among our specific services are:

  • Technology assessment
  • Preclinical toxicology assessment, study design and management
  • CMC/manufacturing guidance
  • Manufacturing assessment and strategy, including vendor selection, cost-of-goods estimating and formulation development
  • Clinical planning
  • Clinical trial strategy and protocol development
  • Pre-market label development
  • Integrated regulatory affairs strategy
  • FDA or other regulatory agency communications
  • Regulatory writing