Below is a list of some frequently asked questions about PRC Clinical, our Services and Experience. If you have a question or would like more detail, please contact us.
We have the answer.
PRC is a full service CRO that specializes in clinical trial management and monitoring of early phase studies and offers a full complement of CRO services including EDC, data management, central lab services, and payment administration services.
Yes, Nearly all of PRC’s services offer the flexibility of stand-alone functionality that can be packaged and tailored to your study’s specific needs and requirements.
No. PRC has study expertise and experience working in a variety of therapeutic areas. We have supported all phase studies and many rare and orphan status indications including neurology, muscle-skeletal, pulmonology, cardiology, gastroenterology and delivery.
PRC has a core monitoring group of regional CRAs based throughout North America. Our seasoned monitoring teams offer expertise in a range of therapeutic areas.
Yes. Our clinical trial management teams are led by project managers with previous monitoring experience and engage clinical staff with an in depth understanding of GCP/ICH, regulatory processes, study start up and design, and clinical data management.
The PRC trial management team has successfully managed many clinical trials of all phases, small (n = 12) and large (n > 700) patient populations, and studies with over 50+ sites in a wide range of therapeutic areas.
Yes, we have an excellent biostatistics team that will assist with and provide feedback on study design.
Yes, PRC has access to a comprehensive site database as well as proprietary investigator profiles. Feasibility is generally conducted as part of our start up activity to ensure site selection.
PRC does not directly handle drug processes; however, through our established network of preferred vendors, PRC can manage drug supply and packaging.
Yes, PRC has experience negotiating mutually acceptable terms with investigative sites and has an excellent system of handling reimbursement and cost management.
Our monitors have on average more than 10 years industry experience. Additionally, PRC provides and requires our staff to attend and maintain GCP/ICH and other industry educational and regulatory trainings.
Yes. PRC maintains a complete set of Standard Operating Procedures and training records available for Sponsor inspection.
We work with all types of research sites from comprehensive phase-I units to practice/research clinic to large university settings. PRC maximizes efficiency in the startup process because we are familiar with many of the recommended Investigators.
PRC has exclusive access to thousands of potential sites and the ability to screen for feasibility, enrollment capability, competing trials, and regulatory agency interactions.
Yes, PRC can support Regulatory Agency (US) IND submissions including Pre-IND meetings and consultation.
Yes, PRC manages Investigator Meetings of all sizes and assures a smooth meeting with comprehensive staff and site training.