FDI Clinical Research (FDI) is a first rate research site with state-of-the-art facilities and medical care clinics with access to a viable patient population for research trials. We have a database of normal volunteers and the capability to conduct clinical trials at all stages of drug development, from First-in-Man, Proof of Concept (POC), to Phase 1 to Phase 3 studies.
We also conduct selected post-approval or post-marketing Phase 4 studies, when there is interest in obtaining additional information, or to analyze the efficacy and safety of a particular drug in special populations.
We have conducted hundredths of clinical trials in multiple therapeutic areas: Infectious Diseases as hepatitis C, hepatitis B, Influenza, and Herpes Zoster; Hematology and Oncology, all types of Cancers including Acute and Chronic Leukemia; Vaccines; Metabolic Syndrome manifestations as Diabetes Mellitus, Arterial Hypertension, Non alcoholic steatohepatitis (NASH) and Obesity; Rheumatology and Immune Diseases as Rheumatoid Arthritis, Systemic Erythematous Lupus, Osteoarthritis and Gout; Respiratory Diseases as Asthma, Chronic Obstructive Pulmonary Disease and others. Our site’s advanced technology includes a phase I unit and an in-house bio-analytical laboratory.
Some clinical trials we have conducted
- Hepatitis C & B
- Herpes Zoster
- Cancers including Acute and Chronic Leukemia
- Chronic Obstructive Pulmonary Disease and others
FDI Bioanalytical Laboratory
Is a unit of FDI Clinical Research de Puerto Rico that specialize in qualitative and quantitative analysis of chemical and biological pharmaceutical compounds. We provide added value to our customers by advising on the scientific and regulatory situations that could arise in the development of these compounds.
We are a one-stop facility where
customers can perform
Phase 1 and Phase 2
Studies in the same facilities including pharmacokinetics and pharmacodynamics assessments. This strategy provides faster results for companies’ decision making process for the development of their products. FDI has conducted trials with confinement duration of up to 16 days, including multiple intensive pharmacokinetics and pharmacodynamics trials as SAD and MAD for many molecules. We also conduct hepatic impairment and drug-to-drug interaction studies. We provide to our customers not only scientific but also clinical expertise in the development of pharmaceutical products. Our scientists have extensive experience in the development and validation of bioanalytical methods in the determination of small molecules and their metabolites.
In addition, our investigators frequently submit research proposals to Government and Pharmaceutical Companies to be conducted as Investigator Initiated Studies (IIS), and we participate in collaborations conducting basic research and also joint ventures to develop drugs in Puerto Rico from local and external biomedical companies. For 2015, we will be conducting in-hospital clinical trials in other populations, like serious infections, pediatrics and emergency medicine.
FDI evaluates all offers and opportunities to conduct clinical trials and works with the sponsors to conduct the studies efficiently, quickly and at the most competitive costs. We also welcome any opportunity to partner in drug development. Our reputation as a top clinical trial enroller, our emphasis on quality, plus our extensive experience in research and development, make us the best choice for your clinical trial. We deliver results for you, faster and better.