Experience

Experience in Drug and Device Clinical Research

GRS' staff provides a unique set of capabilities and depth of experience in the management of clinical trials. The company has completed global projects involving over 24,000 patients including landmark studies in acute coronary syndrome, unstable angina, coronary artery by-pass graft surgery, acute MI, atrial fibrillation, stroke, congestive heart failure, hypertension and diabetes. GRS has access to key therapeutic patient populations for targeted subject enrollment in North America, Latin America, Europe and Asia with the ability to identify, manage and monitor sites with high enrollment capabilities, strong attention to detail and strict adherence to protocol requirements in pivotal regions with a particular strength in cardiovascular research.

Case Study: Enroll over 4,000 Subjects in Less than 9 Months in Order to Present Data at a National Conference

An outstanding example of GRS' enrollment and operational capabilities includes a large multinational cardiovascular study comparing two leading glycoprotein IIb/IIIa platelet inhibitors. GRS enrolled 4,815 subjects in 8.83 months. The 30-day endpoint data were collected, analyzed and presented as a late breaking trial result at the American Heart Association (AHA) Annual meeting just six weeks after the last subject completed the 30-day follow-up visit. As the selected clinical research organization (CRO), GRS provided project and site management, monitoring, safety and regulatory services as well as full data management and biostatistics. The company processed more than 155,000 CRF pages, received/evaluated 675 Serious Adverse Events (including narrative writing), organized 1,960 clinical endpoints for the Clinical Events Committee and prepared >17,000 ECGs for the central over-reading organization. GRS provided true outstanding Speed to Value™ results to our client's global clinical program.

Therapeutic Experience

Over the past 25 years, GRS has established a long-term and successful history as a CRO of conducting clinical trials particularly in cardiovascular, renal and metabolic research. In addition, as a world class clinical research organization with access to global patient populations, GRS has conducted Phase I-IV studies for our clients in a variety of therapeutic areas such as CNS, vaccines, infectious diseases, reproductive health, and oncology. Our staff brings an incredible amount of industry experience to our organization with years of research dedicated to careers in cardiology, nephrology, pulmonary, diabetes, hematology, GI, pediatrics, anti-infectives, and oncology.

Medical Device Experience

GRS is experienced in the different methodologies related to the management of device and drug studies. We have performed numerous studies on medical devices and are intimately aware of the study and regulatory requirements, processes, and potential hurdles involved. We bring expertise to expedite the process of moving new medical devices and in vitro diagnostics to market.