Proper management of regulatory affairs can dramatically shorten the time it takes to bring safe and effective products to market. The PCCTC coordinates the intricate details of regulatory document management throughout a project’s lifecycle, serving as a single point of contact for industry partners and investigators.
Centralized management of regulatory affairs means improved communications and abbreviated timelines.
- The PCCTC specializes in multi-site start-up, coordinating the necessary requirements for sites to open trials and receive investigational products.
- Rapid regulatory expertise, guidance, and executable action plans ensure submissions and activities throughout the lifecycle of a clinical trial meet evolving regulatory requirements.
- Efficient, customized packages of regulatory documents facilitate site start-up activities.
- The PCCTC operates a finely tuned centralized regulatory management plan that facilitates seamless collaboration between investigators, research sites, industry partners and regulatory agencies.