Research Pharmacy
A dedicated research pharmacy with the necessary equipment to prepare, formulate or compound any type of investigational drug
30 bed Phase I unit
Our phase I unit has state-of-the-art monitoring technology designed to manage Phase I trials.
Bioanalitycal Laboratory
Bioanalytical Laboratory (FBL) is a unit of FDI Clinical Research that specialize in qualitative and quantitative analysis of chemical and biological pharmaceutical compounds.
What makes us UNIQUE
FDI Clinical Research invested $7 million on our facilities and the best up-to-date equipment. We can conduct trials from normal volunteers to phase IV. FDI has strict security and confidentiality controls that guarantee that research and samples are reliable, protected and evaluable for sponsors.
FDI Clinical Research
Since 2010, we have conducted multiple clinical trials in Breast, Prostate, Hepatoma, Head and Neck, Gastric, and other types of cancers. We have also participated in various Phase 1 studies. Our expert oncologists are regarded to be in the forefront of treatment and have become speakers to multiple pharmaceutical companies for the Hispanic population. Contact us to help you run your clinical trial more efficiently and faster. selected for their competence, dedication and interest in clinical research.
What we can help you achieve your clinical trial
Trials
- Gastroenterology
- Gynecology – OB/GYN
- Hematology / Oncology
- Infectious Diseases
- Liver Diseases
- Normal Volunteers
- Registry Studies
- Respiratory Diseases
- And many others
FDI have conducted oncology trials in the following areas:
Bladder Cancer • Myelodysplasia • Lung Cancer • GBM • Hepatoma • Prostate Cancer • Gastric-GE Junction Cancer • Colon Cancer
Also we have conducted trials in the following areas:
Diseases as hepatitis C, hepatitis B, Influenza, and Herpes Zoster. Hematology and Oncology, all types of Cancers including Acute and Chronic Leukemia, among others
High Enroller Reputation
FDI is recognized as a center for excellence in medical care and a premier site for research on Latino patients
Bioanalitycal Laboratory
Bioanalytical Laboratory (FBL) is a unit of FDI Clinical Research that specialize in qualitative and quantitative analysis of chemical and biological pharmaceutical compounds.
FBL has more the 15 years of experience in the development of analytical methods for the determination of small molecules, peptides, and metabolites in different human compartments including plasma, serum, urine, peripheral blood mononuclear cells, and tissue samples.
Fatty Liver Disease
At FDI-Clinical Research, we have run multiple studies with NAFLD and NASH. The Hispanic population is eager to participate. Contact us to show you our capabilities.
Collaboration
We are in collaboration with the Hematology and
Oncology Section of the University of Puerto Rico to conduct clinical trials in hospitalized patients.
Alliance for Clinical Trials in Oncology
FDI is a main member of the Alliance for Clinical Trials in Oncology, a national clinical trials network sponsored by the National Cancer Institute.
What makes us UNIQUE
Research Pharmacy
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.
Our Staff
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.
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.
Latino Population
FDI Clinical Research (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.
Tax Credits
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.
