Located in San Juan, Puerto Rico,

FDI Clinical Research is a center

with state-of-the-art facilities

FDI Clinical Research is a center with state-of-the-art facilities that comprise medical treatment for multiple conditions, a 30-bed phase I unit, an in-house bioanalytical laboratory, multispecialty experienced personnel, and the latest in medical technology. We have successfully completed hundreds of FDA-regulated clinical trials sponsored by numerous pharmaceutical companies. Our site has enrolled thousands of patients in chronic hepatitis C clinical trials alone.

We are also an active medical care facility for patients with diverse medical ailments including liver diseases; metabolic disorders such as diabetes, hypertension and lipidemias; oncology and hematology, neurologic, musculoskeletal and infectious diseases. Our facilities include nurse stations, medical offices, exam rooms and chemotherapy or infusion chairs. We also have a complete research pharmacy with a clean room for the preparation of chemotherapy and investigational drugs.

FDI moved to its new facilities at 998 Muñoz Rivera, Río Piedras on July 2010. These facilities were the result of many months of careful discussion, design and location selection.

We increased from 3,000 sq. ft. to 20,000 sq. ft. in working space, adding the only Phase 1 facility in Puerto Rico and the only Bio-Analytical Laboratory. The facilities were designed to permit both medical care and clinical research, and to comply with all FDA and Federal Research Regulations.

Big Vision

To become a worldwide engine in Clinical Research, performing and developing innovative clinical trials and medications in multiple therapeutic areas.

Mission

To conduct innovative clinical research by our expert health-professional team, providing an environment to ensure enrollment targets and the highest-level of quality, following ethical standards and contributing to the wellbeing of our population

Our Values

To fulfill our Purpose and achieve our Vision, we abide by the enduring values that are the foundation of our business.

  • Patient Focus: We are deeply committed to meeting the needs of our patients, and we constantly focus on their welfare and safety.
  • Respect for People: We recognize that people are the cornerstone of Fundación success, we value our diversity as a source of strength, and we are proud of Fundación history of treating employees with respect and dignity.
  • Innovation:: is the key to improving health and developing new therapies. To be part of early development of therapies is key for Fundación to sustain growth and profitability.
  • Teamwork: We know that to be a successful company we must work together, to meet the changing needs of our patients and the new paradigms for treatment.
  • Integrity: We demand of ourselves and others the highest ethical standards, and our procedures and performance to be of the highest quality.
  • Community: We play an active role in making the community in which we operate a better place to live and work, knowing that its ongoing vitality has a direct impact on the long-term health of our business.
  • Performance: We strive for continuous improvement in our performance, measuring results carefully, and ensuring that integrity and respect for people are never compromised.
  • Leadership: We believe that leaders empower those around them by sharing knowledge and rewarding outstanding individual efforts. Leaders are those who step forward to achieve difficult goals, envisioning what needs to happen and motivating others.
  • Quality: Quality is ingrained in the work of our colleagues and all our Values. We are dedicated to the delivery of quality healthcare in our community and to the discovery of better and safer therapies. Our business practices and processes are designed to achieve quality results that exceed the expectations of all of our stakeholders.

Clinical Trial Sponsors

Abbott
Amgen
Anadys Pharmaceuticals
Astra Zeneca
Bristol Myers Squibb
Eximias Pharmaceuticals
Forrest Research Institute
GlaxoSmithKline
Human Genome Sciences
Idenix Pharmaceuticals
Idera Pharmaceuticals
Intarcia Pharmaceuticals
Intermune
Merck Sharp
Novartis Pharmaceuticals
Pharmasset
Pfizer
Procter & Gamble
Roche Laboratories
Sanofi-aventis
SciClone Pharmaceuticals
Tibotec Pharmaceuticals
Valeant Pharmaceuticals
Vertex Pharmaceuticals
Virochem Pharma
Wyeth Pharmaceuticals

Clinical Research Organizations (CRO)

CATO Research
Covance
Duke Clinical Research Institute
ICON
Kendle International
Medifacts International
Parexel
Pharmaceutical Research Associates (PRA)
Pharmanet
Phase to Phase Clinical
PPD Development
Quintiles
SC Liver Research Consortium

Institutional Review Boards (IRB)

Chesapeake Review Board
Coast IRB
Copernicus Group IRB
Ethical Review Committee
IRB Ponce School of Medicine
IRB UPR Medical Science Campus
Quorum Review Board
Research Consultants Review Committee
Western Institutional Review Board (WIRB)
300+
Studies
18+
Years
25+
Staff
5k+
Patients/Volunteers

1,000+

Cured Hepatitis C Virus "HcV"

Executive Leadership

Dr. Jose F. Rodriguez-Orengo

Chief Executive Officer, Chief Scientific Officer & Bioanalytical Laboratory Director

Dr. Rodriguez-Orengo obtained his BS with concentration in chemistry (Magna Cum Laude) from the University of Puerto Rico, Rio Piedras Campus in 1985. He was awarded a Minority Biomedical Research Program Award in 1983 to perform his undergraduate Research. As an undergraduate student presented several times including national meetings. He moved to Texas A&M University obtaining his Ph.D. in chemistry in 1989. He obtained various scholarships and fellowships from the Puerto Rico government, the University of Puerto Rico, Hispanic Fund and the Robert Welch Foundation.

In 2009, joined FDI Clinical Research, a private clinical research center to foster more research in Puerto Rico. In 2011, returned to the Department of Biochemistry where he is member of the Academic Senate and Graduate Coordinator. With Dr. Raul Mayo designed the graduate course entitled: From Mendel to Collins: History and Philosophy of the Genetic Code. He was named Acting Chancellor at the UPR-Medical Sciences Campus from May 2013 until Jan 2014. Dr. Rodriguez Orengo leads the state-of-the-art Bioanalytical laboratory at FDI where multiple analytical assays have been developed and validated complimenting FDI clinic to become a one-stop-shop for pharmaceutical companies. Numerous investigator initiated research projects are underway at FDI. As FDI new CEO, he has the vision of integration and collaboration among different entities towards a common goal of promoting Puerto Rico as a premier location for clinical research.

Grisell Ortíz-Lasanta, MD

Associate Director Internal Medicine

Grisell Ortiz-Lasanta, Clinical Research Associate, Sub-Investigator and Principal Investigator at Fundación de Investigación earned her medical degree from the UPR School of Medicine in San Juan on 2004. She completed her internship and Internal Medicine residency at the UPR School of Medicine. Dr. Ortiz-Lasanta is a member of the American College of Physician and was a student member of the American Chemical Society on 1997. Her clinical interests include: Hepatitis C in the Latino population, Hypertension and Diabetes. Dr. Ortiz-Lasanta has been conducting research since 2007 and is trained under Good Clinical Practices. She has been reviewer of different Journals including: Annals of Hepatology and Journal of medical Virology.

Michelle Echeandia

Clinical Operations Director

Michelle Echeandia obtained her bachelor’s degree in Science with concentration in Biology in the University of Puerto Rico. She then made her post bachelors degree in Medical Technology in the University of Puerto Rico-Medical Science Campus followed by a master’s degree in Molecular Biology in the Interamerican University of PR.

She started in FDI in 2006 as a clinical Study Coordinator for trials in different therapeutic areas as hepatitis C and oncology, and also conducted phase I trials with pharmacokinetics and pharmacogenetics specialty and experience. Then she created and directed the Quality Control Program where she implemented different operational standards and in-house audit programs.

Since 2011 she has become part of the executive team in FDI as the Clinical Operations Director where she supervises daily operational procedures at the center and part of the clinical team. She is in charge of the ongoing process of all clinical trials including phase I, II, III and IV trials, budget negotiations and contracts as well as programming monitor’s and auditor’s visits from different sponsors and FDA. Actually she is also Co-Director of the Quality Control Program and team she helped to design. She also collaborated in different manuscripts and abstracts directed by our founder Dr. Maribel Rodríguez-Torres.

Earning a solid reputation

John McHutchison, Senior Vice President, Liver Disease Therapeutics, Gilead Sciences

I have worked closely with Dr. Rodríguez-Torres and her unit for more than a decade. I remain continually impressed by their level of service, professionalism and approach to the science and the partnership. Their commitment to patients is clear across every aspect of their work. Our team works very well with the hepatology group at Fundación de Investigación and they have helped us effectively advance key clinical trials in a competitive and fast moving therapeutic area.

Jan Hillson, Medical Director, ZymoGenetics/Bristol Myers Squibb

It has been a great pleasure to work with Fundación de Investigación during the critical studies conducted by ZymoGenetics; indeed your participation has been critical to our success. Your group is serving a large number of high-needs patients in San Juan, so it has access to populations with uncommon diseases. Your facility has capacity for FIH studies, intense PK profiling, as well and long-term clinical assessment. Your staff is highly trained and equally highly motivated to provide outstanding care, detailed and careful documentation, and very rapid response to sponsor concerns and questions. As importantly, your knowledge and insights have informed our protocols and development plans.

Dr. Ignacio Pino, President, CDI Laboratories

From the biomedical sciences industry perspective, Fundación de Investigación has a combination of talent, expertise and vision that make it a world-class organization.

Linda Wasserman, Principal CRA, CRO, PPD

Fundación de Investigación is a modern research facility with a dedicated, experienced and well-trained staff. This site is at the top of the list to contact for clinical trial participation when our sponsors want qualified, experienced, and reliable investigators to conduct their trials.

Shyamasundaran Kottilil MD., Ph.D., Staff Physician, NIH/NIAID/LIR

I have had the opportunity to work with Dr. Maribel Rodríguez-Torres and Fundación de Investigación in several collaborative projects. Without any doubt, they are one of the best collaborators we have ever worked with. They are the most professional, organized and wonderful group of collaborators to work with. The staff is cordial and passionate about every aspect of patient care and understands the role of clinical research as a way to move science forward. It is no surprise that Dr. Rodríguez-Torres has reflected upon her staff excellent, selfless leadership that has transformed Fundación de Investigación as one of the leaders in hepatitis research worldwide.