|FDI Clinical Research invested $7 million in 2010 to remodel our facilities and obtain the best up-to-date equipment. We can conduct trials from normal volunteers to phase IV under the same roof. FDI has strict security and confidentiality controls, computerized temperature monitoring and emergency backup generators that guarantee that research and samples are reliable, protected and evaluable for sponsors.
FDI has a dedicated research pharmacy with the necessary equipment to prepare, formulate or compound any type of investigational drug. The research pharmacy includes a clean room with equipment that allows us to comply with USP’s Chapter 797 in the production of sterile formulations of all risk levels. Investigational drugs are kept under strict security controls with access limited as per protocol. Our dedicated research pharmacy personnel is trained to work with any investigative product need, including pharmacist unblended and blinded trials.
FDI has a growing, dynamic and enthusiastic staff that includes physicians of different specialties such as internal medicine, hepatology, gastroenterology, oncology, endocrinology, family medicine, pediatrics, infectious diseases, neurology, psychiatry and basic science. We also employ Ph.D.s in chemistry, biochemistry and pharmacy; multiple masters’ and bachelors’ in medical technology, graduate nurses, research nurses, research assistants, physician assistants, educators and accountants. We contract all the necessary personnel required to conduct clinical trials quickly and efficiently.
Our staff understands the seriousness and importance of our work and knows that only the best patient care and research conduct is acceptable. These professionals have great pride in FDI’s achievements and in our mission to contribute to the development of innovative medicines that improve our patients’ health and quality of life.
Clinical Trial Experience
FDI has over 18 years of continuous research experience. Our staff has published over 150 manuscripts in prestigious journals such as The New England Journal of Medicine, Hepatology, Journal of Hepatology, and the Journal of Clinical Gastroenterology and presented hundreds of abstracts at medical conferences. We have been instrumental in the development and approval process of several drugs against chronic hepatitis C. Our founder and medical director, Dr. Maribel Rodríguez-Torres, was influential in the approval of pegIFN-2a and RBV for co-infected patients with HCV and HIV in 2003. She also conducted the first trial in the world in which 6 patients received a combination of Telaprevir/peflFN and RBV for HCV therapy.
High Enroller Reputation
FDI has an excellent reputation as a top clinical trial enroller. Treating patients at our facilities enables us to screen and recruit appropriate candidates for our clinical trials. We have a history of high enrollment rates in most HCV and oncology studies performed at our facilities. In case of any difficulty finding adequate subjects for a clinical trial, we organize and conduct aggressive outreach activities to boost those numbers.
Fundación de Investigación (FDI) is recognized as a center for excellence in medical care and a premier site for research on Latino patients. Our patients have a positive attitude toward clinical research and are responsible and compliant with study procedures. Our location in Puerto Rico and our medical care treatment model allow easy access to a good pool of Latino patients for clinical trial participation. Latinos have a high prevalence of many infectious, neurologic and chronic diseases including metabolic diseases and cancer. The plethora of medical conditions seen in this population guarantees that our Latino patients are willing to participate in various disease trials. As the largest minority group in the United States, regulatory agencies such as the FDA require this ethnicity’s representation in trials relating to most medical conditions.
The Puerto Rico Government offers an attractive set of incentives to the pharmaceutical industry that invest in research and development in our island. By engaging FDI to conduct any clinical trial, sponsors may be eligible to receive tax credits from the Puerto Rico Treasury Department. Through the Economic Incentives for the Development of Puerto Rico Act (Act 73 of May 28, 2008) your company can obtain up to 50 percent tax credit on every dollar invested on your clinical research contract with us. These tax credits could be used against your local tax liabilities or may be sold or transferred to an entity with tax liabilities in Puerto Rico.