Yale Pharmaceutical Research Institute has performed a multitude of comprehensive clinical trial services in both the public and private sectors. YalePharma seeks challenges that go beyond routine safety and efficacy trials, and the Institute focuses its research efforts on complex pharmaceutical projects that require unique solutions.

YalePharma' multidisciplinary staff of researchers are experienced in all phases of drug discovery, development, and outcomes assessment and have fully served the pharmaceutical industry. Our staff capabilities are enhanced by our access to national networks of physicians through our affiliation with the Permanente Medical Research Institute , in addition to our medical association with two of YalePharma' International network.

YalePharma worked closely with government and industry professionals to develop clinical trial data collection and validation procedures that now serve as a model for ongoing government trials.

Clinical Trial Capabilities

For pharmaceutical industry clients, YalePharma can:

• Consult on study design
• Develop statistically sound and operationally feasible study protocols
• Design comprehensive case report forms
• Recruit sites and investigators
• Develop informed consent forms and other materials for human subjects review
• Assist in obtaining IRB approval
• Prepare clinical trial operations manuals
• Develop study procedure training for site personnel
• Implement interactive telephone randomization systems
• Develop data collection and data management procedures, including innovative computerized data collection and transmission technologies
• Conduct interim and final statistical analyses.

Through ongoing relationships with external companies and institutions, YalePharma can provide:

• Completion of all regulatory forms and assessment of regulatory compliance in clinical trial procedures
• Pharmacy support, including training of site staff, shipping and dispensing of drugs, and drug inventories
• Clinical monitoring of study site documentation
• Timely reports of adverse events.