Nonclinical study design, placement, and monitoring are key activities conducted both before and after a lead candidate has been selected. Prior to lead selections, the nonclinical approach is key to ensuring that the information generated is robust, compliant, and will ultimately enable compound selection. Once a lead candidate has been selected, these activities ensure the study will successfully support the client’s unique clinical plan. Nonclinical studies need to be designed to ensure they meet regulatory requirements, are placed at high-quality clinical research organizations (CROs), and appropriately monitored.
A CRO’s protocol templates may not adequately address a Sponsor’s unique needs. As such, it is important that individuals with knowledge of the product’s distinctive characteristics be involved in study development to assure that testing is relevant to the overall development plan. It is important to be proactive and begin with the endpoint of the clinical plan in mind. Our consultants can assist with all of these activities while maintaining communication with the client throughout the process and ensuring cost efficiency.
Our Specific Study Design, Placement, and Monitoring Services Include:
- Provide customized study synopses for drugs, biologics, and medical devices that incorporate features that address relevant regulatory requirements and Agency feedback for bidding by CROs
- Review protocols provided by CROs to assure that the design incorporates features to address the client’s needs as well as applicable regulatory requirements
- Place studies at the appropriate CROs based on our knowledge of site qualifications and CRO-specific cost and timelines
- Monitor the conduct of the study (may include technical meetings with the scientific staff, review of study procedures to ensure Good Laboratory Practices [GLP] compliance and scientific integrity)
ProPharma Group Can Assist With Your Study Design, Placement, and Monitoring Needs
Study design, placement, and monitoring is a critical component of nonclinical drug development. Ensuring that it is done correctly the first time is essential to your development program’s success. Are you interested in minimizing the risk of noncompliance? We can help confirm that your studies have been designed according to all regulatory requirements, assist in selecting a high-quality CRO that meets your specific needs, and ensure that they are appropriately monitored throughout the process.