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The Clinical Trials Office (CTO) respects the necessity to maintain rigorous patient safety standards, while still recognizing the importance of bringing medical innovation to patients as quickly as possible. The CTO therefore provides a diverse menu of services to sponsors and investigators to ensure efficient time to market for cutting-edge treatments. At the CTO, our sponsors can be assured that the reputation and academic prestige of our institution and affiliated sites enhances the credibility and publicity of trial results.

To fulfill a mission of supporting the collaboration of investigators and their pharmaceutical sponsors, and to enable them to provide innovative, safe, and effective treatments with maximum efficiency, the CTO relies upon an experienced team of University / Hospital administrative personnel with in-depth experiences in Pharmaceutical Industry, Hospital, and University environments.

Click here to see a partial list of past and present sponsors with whom our institution has collaborated.


Comprehensive Services

CTO services include advice for all aspects of the proposal process, including evaluation of scientific merit and FDA submission preparedness. The CTO ensures efficiency of study start-up through centralized processing and review of all aspects of proposal needs, including identification of investigators and therapeutic area thought leaders, assistance with regulatory documents, and budgetary review. To streamline the contracting process, for example, the CTO has enacted several departmental initiatives, including online proposal submission processes and pre-approval of standardized contract language.

The CTO also provides clinical, legal, and financial study management, including aggressive patient recruiting techniques, regulatory document maintenance, pharmaceutical and device management, and budgetary oversight.


Experience and Expertise

The CTO staff has unique expertise that can only be gained through years of in-depth industry experience and a thorough understanding of investigator and sponsor needs. The following list is just a short review of the expertise the CTO staff brings to the clinical trials process:
  • NDA, ANDA and sNDA preparations
  • Pharmaceutical Organizational Reengineering
  • International Clinical Research administration
  • ICH conference participation
  • Phase 3, 3B and 4 investigations for prescription pharmaceuticals
  • Submission of materials for non prescription pharmaceuticals, cosmetics and nutritionals
  • Due diligence for potential licensing of prescription medications
  • Maintenance of clinical data bases for Drug Safety submissions
  • Investigator Initiated Research Programs assisting physicians and other investigators to:
    • Identify opportunities for lifecycle drug management
    • Obtain funding for the investigation of new indications
    • Publish investigative findings
  • Clinical Liaison activities division to evaluate and foster investigative initiatives in the prescriber community
  • Community of Practice activities to create synergies with Marketing Departments
  • FDA Advisory Committees preparation and testimony
  • FDA Risk Management Programs
  • Continuing Education Programs for physicians, physician assistant, nurse practitioners and nurses
  • Review of marketing materials in preparation for FDA-DDMAC submission
  • Corporation witness for liability claims
  • Regulatory systems and Standard Operating Procedures and Master Books for review of Manufacturing, Distribution, Operations, Sales, Marketing, Quality Assurance and Finance for compliance with 21 CFR
  • Quality Assurance systems
 
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