Experience

Experience in Drug Development

GRS’ staff provides a unique set of capabilities and depth of experience in the management of clinical trials, particularly in the cardiovascular, cardio pulmonary, cardio renal, stroke, CNS, and metabolic therapeutic areas. The following table is a partial listing of our drug development experience.

Class	Indication	No. Pts	No. Sites	Service
Vasodilator Combination	CHF	1,050	170	Full
Endothelin Receptor Antagonist	CHF	533	29	Full
Xanthine Oxidase Inhibitor	CHF	400	40	Full
Atrial Naturetic Peptide Inhibitor	CHF	1500	150	Monitoring
Immune Modulating Therapy	CHF	455	20	Project Mgmt, Monitoring
Heparin Reversal Agent	CABG	300	45	Project Mgmt, Monitoring
Oral Heparin	DVT	145	15	Full
ADH Receptor Antagonist	Hyponatremia	200	55	Project Mgmt, Monitoring
Adenosine Receptor Antagonist	CHF	200	50	Full
Beta Blocker	Hypertension	250	16	Full
Anti-Hypertensive HRT Combination	Hypertension/ Menopause	236	43	Monitoring
ACE Inhibitor	Hypertension	500	44	Project Mgmt, Monitoring
IIb/IIIa Glycoprotein Platelet Inhibitor	CAD	4,815	150	Full
Viral Protein	CAD	72	12	Full
Amiodarone derivative	Atrial Fibrillation	80	16	Monitoring,PM
Pyridoxine derivative	CABG	435	10	Montoring, Safety, PM
Monoclonal Antibody	CABG	900	75	Full

Experience in Medical Device Development

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. The following table lists the device studies in which GRS has recently participated.

Class	Indication	No. Pts	No. Sites	Service
Biliary Stent	Biliary Obstruction	40	9	Project Mgmt, Data Mgmt, Safety
Iliac Stent	PVD	203	20	Data Mgmt
OTW Device	CAD	250	10	Monitoring
Drug-Eluting Stent	CAD	2000	40	Monitoring
Stent + Device	CAD	5000	150	Full Service
Distal Protection Device	CAD	150	15	Monitoring
Debris Extraction Device	CAD	800	75	Monitoring
Coated Stent	CAD	266	17	Full Service
Coated Stent	CAD	266	29	Full Service
High Scaffolding Stent	CAD	150	12	Data Mgmt
Coated Stent + Distal Protection Device	Carotid Stenosis	800	50	Project Management and Monitoring
Carotid Stent	Carotid Stenosis	50	15	Data Mgmt, Safety
Thoracic Stent	Thoracic Aneurysm	232	16	Data Mgmt, Monitoring
Thoracic Stent	Thoracic Aneurysm	390	35	Monitoring
Abdominal Stent	Abdominal Aneurysm	275	40	Full
Catheter	Atrial Fibrillation	40	2	Monitoring
A-V Graft	Renal Failure	50	8	Full Service
Wound Closure Device	Post angioplasty	540	12	Full Service