Enhance Your Drug Development Capacity with Clin Pharm Study Execution & Operational Support

Typically, pharmaceutical companies engage a contract research organization (CRO) to design, conduct, and analyze their clinical pharmacology studies. On the surface, selecting and managing a CRO for this part of clinical drug development is straightforward provided the sponsor company has the necessary experience and bandwidth. However, oftentimes sponsors run into numerous challenges with this process:

Navigating a confusing bid process: How do you compare CROs and select the best one to suit your program’s needs and deliver on their proposals?
Managing study startup and conduct: How do you ensure that your clinical pharmacology studies are designed and conducted appropriately? For example, are the drugs prepared, handled, and administered properly in studies using radiolabeled compounds? Are study assessments feasible? Do you have resources that can immediately address any issues that arise at study sites?
Ensuring proper data management and analysis: How do you know that the right data is collected and that it is analysis-ready?
Time line control: Most large CROs have extended time lines for database lock and delivery of tables, listings, and figures (TLFs) and draft clinical study reports. How do you mitigate this against the planned new drug application (NDA) time lines?
Cohesive Clinical Pharmacology Program: How do you maintain cross-functional collaboration with several different studies ongoing, often in parallel? Are you able to place these studies’ results in the context of your larger clinical development plan?
In short, a suboptimal clinical pharmacology program wastes time and money, and it impedes your ability to make critical decisions on future clinical studies.

Certara’s global team has the expertise you need. In this webinar, Darrell Nix and Jo Ann Malatesta explained how Certara partners with sponsors and CROs to provide flexible solutions that fit your drug program’s needs.