RESEARCH OPERATIONS

PRN Research Team consists of a group of qualified and experienced clinical research managers and clinical research coordinators. Clinical research operations are carried out under the scrutinized guidance of the Chief Scientific Officer, who is a physician and an experienced clinical investigator. During the last 3 years, the following departments have successfully and cost-effectively managed more than 35 clinical trials:

• Project Management: Deals with harmonization of all matters related to clinical site management and clinical research coordinators.



• Quality Assurance: Routine in-house monitoring of quality assurance of all active clinical sites by stringent criteria according to the GCP-ICH guidelines.



• Regulatory Affairs: It undertakes the storage and timely submission of appropriate regulatory documents to the sponsor and IRB.



• New Studies Development: It is involved with the evaluation, selection and subsequent implementation of newly contracted clinical trials.



• Financial Management: Deals with fiscal management of all clinical trials undertaken by PRN.



• Clinical Research Coordinators (CRCs): Under the supervision and guidance of the Project Manager, a cadre of qualified and trained CRCs participate in an efficient management of assigned clinical sites according to the GCP-ICH guidelines.

MAIN RESEARCH OFFERINGS

• Comprehensive and multi-site clinical trial project management



• Identification and selection of qualified clinical site and investigator



• Timely and accurate recruitment of study volunteers



• High quality data acquisition, storage and transmittals to the sponsor & IRB



• Centralized IRB documentation and contract negotiation