Clinical and Product Development

Move forward. Efficiently and effectively.

inVentiv Health Clinical offers the regulatory, medical, and pharmaceutical expertise our clients to efficiently advance a product from R&D to early phase clinical studies. Our experts can assist you with top-level strategic planning and evaluations that can maximize the chances for a successful new product development program.

In Phase I-IIa, inVentiv Health Clinical provides valuable guidance for small biotechnology and pharmaceutical companies with new molecular entities or generic Active Pharmaceutical Ingredients (APIs), including performing due diligence, selecting the best API candidate, and determining the optimal formulation for the intended route of administration.

In addition to identification of development candidates emerging from discovery, we can review products and portfolios to support sponsors’ licensing in/out strategies. To bridge the gap from bench to clinic, we’ll prepare non-clinical plans to support clinical trials, including non-clinical plans for inclusion of women of childbearing potential and children. We’ll help you consider options such as an exploratory IND with tailored toxicology programs, or evaluate the impact of adverse findings in non-clinical safety studies.

Our expert support services can also help clients navigate the challenging 505(b)(2) NDA regulatory pathway.

Other clinical and product development consulting services include:

  • Regulatory risk assessment
  • International regulatory consultation
  • Global safety and pharmacovigilance
  • Biostatistics
  • Risk assessment for therapeutic protein immunogenicity
  • Proof-of-principle and adaptive trial design
  • Objective advice on advertising and promotion
  • Management of the clinical supply and associated stability studies
  • Product acquisition analyses
  • Clinical development plans
  • Special protocol assessments (SPA)