Mission Statement
To promote Quality Clinical Research at Temple University's Health Science Campus consistent with its high standards for being a leading teaching and research Institution in the Greater Philadelphia Region. The Office of Clinical Trials seeks to expand the scope and enhance the efficiency of industry sponsored clinical trial activities at Temple University.
Performance Standards Include:
Initiating and Facilitating interaction with industry to identify Clinical Research Opportunities that match the strengths of Temple's clinical investigators with the pharmaceutical industry's multi-disciplinary theraputic areas.
Promoting Interdisciplinary Research and collaboration among researchers and resources at Temple University to expand Temple Univerisity's comprehensive research program
Facilitating Investigators in developing and maintaining an infrastructure to enhance administrative and technical support that satisfies the demands of the pharmaceutical industry for conducting quality product development clinical research.
Maintaining an efficient administrative unit capable of effectively negotiating and executing clinical trial agreements and budgets with best practice benchmarks.
Promoting compliance with established federal regulations, FDA guidelines and policies and IRB requirements through workshops, presentations and one-on-one tutorials.
Sponsor Value Added Services :
Primary Point of Contact for Industry Representatives seeking Qualified Investigators and identifying other resources at Temple University
Collaborate with Industry in the Development and Start-Up of Investigator Initiated Clinic Research Opportunities
Streamline the Contractual and Budget processes to assist with the timely study start up while providing the support for the Institutional and Regulatory requirements and compliance with current regulatory standards
Temple offers experienced Certified Clinical Research Professionals to support Clinical Trial Conduct
Promote ongoing clinical trials to enhance subject/patient recruitment
Good Clinical Practice Quality Improvement Training for Investigators and Research Personnel
Investigator Value Added Services :
Central Source for all Clinical Trial Agreement Negotiation and Execution
Central Source for all Clinical Trial Budget Development and Negotiation
Facilitate Sponsor/Investigator pre-study communications and site visits
Complete Pre-Study protocol evaluation and site feasibility assessments
Guidance and Facilitation for the Institutional Review Board Process
Ensuring timely completion of Regulatory Requirements for study and assisting with site preparation
Assist with the development of recruitment and enrollment strategies
Recommend certified clinical research professionals to support clinical trial activities
Conduct seminars and provide one-on-one training for clinical research staff