Triangle Clinical Research International (TCRI) is a clinical research advisory and management company focused on assisting academic and medical center leadership and research personnel in the optimization of the administration and operational conduct of clinical studies, protecting and building the institution’s brand, insuring regulatory compliance, maturing research to commercialization and growing the institution and investigator’s clinical research engagement with both government and commercial sponsors.
Our Engagement Portfolio
TCRI develops, implements and manages strategic and tactical systems within academic and medical center clinical research institutions to insure;
- Regulatory and quality compliance,
- Physician/faculty engagement in areas of specific research interest and relief from operational and administrative burden
- Adequately trained and experienced personnel to efficiently and effectively conduct clinical research,
- Operational and organizational optimization and efficiency,
- Confidence and attractiveness to grant and commercial sponsors,
- Protection of Institutional Brand
- Minimization of risk, and
- Appropriate Institutional governance that supports the goals and objectives of investigators and administration.
Meet the Team
Each of our Principals and team members possess the unique experience of operational, administration, regulatory compliance and organizational development leadership within academia, medical centers, industry and Clinical Research Organizations.
Dave Gessner, Managing Partner
- 25 years of leadership experience within industry, academia and non-profit research institutions such as Duke Medical, Duke Clinical Research Institute, Quintiles, PPD, PRA, David H Murdoch Research Institute and Radiant Research focused on operational infrastructure, business development, product and organizational expansion, acquisitions, performance metrics and licensing.
- Head – Strategic Development, Duke Clinical Research Institute
- Co-founder of biomarker and diagnostic development companies, Clingenics and Gentris.
- Established analytical and clinical research facilities in the US, Europe, Asia and India.
Bill Elmore, Managing Partner
- 20+ years of executive and leadership experience in academic, industry, US and International CROs and Site Research Organizations
- CFO of Duke Clinical Research Institute which included Duke Site responsibilities
- Director of WakeMed Clinical Research Institute during initial start-up and development period
- President of SPRI Clinical Trials which focused on European sites from US Sponsors
- Global VP for AAI Pharma which covered 12 countries including US, Europe, and Latin America
- Global Director of Finance, Contracts, and Proposals at ClinTrials Research which was first publicly owned CRO
Phil Lemons, Executive Partner
- 20+ years of experience across industry, non-profit organizations and academia including Duke Medical Center, Duke Clinical Research Institute, PRA, Medtronic and Momentum Research Inc. and the African Heart Initiative focused on operational infrastructure, business development, proposals, contracts, performance metrics and licensing.
- Head – Cardiovascular Business Operations, Duke Clinical Research Institute
- Co-founder of Momentum Research Inc., a Heart Failure focused clinical research and consulting company which grew to include offices in Argentina, Switzerland, and Russia
- Director and Board Member of the African Heart Initiative focused on better understanding and improving Heart Failure care in Sub-Saharan Africa
Lisa Zimmerman, Executive Partner
- 25 year proven track record of success in Regulatory Affairs, Regulatory Compliance, Clinical Operations, and Quality Assurance in all areas of drug and device development.
- Director of Quality Assurance and Regulatory Compliance at global CRO.
- Developed and led the QA and Regulatory Affairs functions as well as the Medical Device Unit, GCP and GMP training programs for DCRI and Duke. Hosted FDA and DHHS audits for DCRI and Duke, and met with FDA on key topics affecting compliance.
- Progressive roles at Pozen Pharmaceuticals including Vice President of Quality Assurance and Clinical Operations, guiding all aspects of the drug development process from drug design and strategy to writing sections of the NDAs, to meeting with the Agency and responding to feedback leading to NDA approvals for two drugs, Vimovo and Yosprala.
- Consultant to academic institutions as well as startup and early stage drug and device companies.
Jimmy Melton, Executive Partner
- 30 years of leadership experience with academic institutions, commercial entities, and the interface between them
- Senior executive at multiple, high growth companies across industries and countries.
- Strategic consultant to numerous ARO’s, CRO’s, life science companies, and healthcare data firms.
- Central role in formation and growth of DCRI.
- Executive roles managing public-private endeavors involving NIH, CDC, USAID and other international government entities and foundations.