Experience

Experience in Drug and Device Development

GRS' staff provides a unique set of capabilities and depth of experience in the management of clinical trials with a specialized focus on the development of cardiovascular, renal and metabolic drugs, biologics and medical devices. 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 cardiovascular patient populations for subject enrollment in North America, Latin America, Europe and Asia. GRS' ability to identify, manage and monitor sites with high enrollment capabilities, strong attention to detail and strict adherence to protocol requirements has made it the first choice for cardiovascular, renal and diabetes trials in pivotal regions.

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

An outstanding example of GRS' enrollment and operational capabilities in a cardiovascular study includes a large multinational 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. 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 outstanding results for true value to our clients.

Therapeutic Experience

GRS' research efforts are focused on cardiovascular, renal and metabolic therapeutic areas. However, as a world class clinical research organization with access to global patient populations, we have 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 done 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.