Protocol and Regulatory Consulting

As part of ResearchPoint’s standard offering, we complement the research and development function of pharmaceutical, biotechnology, and medical device companies by providing a number of consulting and regulatory services.  We recognize that regulatory input is a critical area for product development and we assist our clients with both regulatory strategy as well as guidance on regulatory document preparation.  Specifically, ResearchPoint offers:

• Complete protocol development
• Statistical services (sample size estimation, randomization, and Data and Safety Monitoring Boards)
• Case Report Form and Completion Guidelines design
• Literature review
• Medical writing
• Regulatory guidance

Having developed or consulted on protocol development across a broad range of therapeutic areas,
We only have an A-team.