COPLEY PROCAINAMIDE CLINICAL TRIALS TO BEGIN IN JUNE
Executive Summary
COPLEY PROCAINAMIDE CLINICAL TRIALS TO BEGIN IN JUNE under the guidance of Clindar, a new clinical testing firm. Under a recent agreement, Clindar will oversee the bioavailability testing for six products for Copley Pharmaceuticals, a Boston-based generic mfr. Clindar is also reportedly set to begin testing this summer for products from two New Jersey firms, Invamed and Able Pharmaceuticals. Clindar was founded in May, 1984 to set up clinical research services in anticipation of the increased demand for outside contract research to support generic applications. The company was started by William Milton Bates, a radiology technician who was previously director of industrial development at the Duke Medical Center Radiology Department. The company maintains that Eckerd Chairman Stuart Turley is an early investor in the company. The clinical research company describes itself as a hospital based system, founded on contracts with private hospitals and medical centers. The company's approach is "to sign a formal contract with hospitals for all the services that are needed to support a complete clinical study." Clindar has signed contracts with four hospitals in North Carolina: Franklin Memorial Hospital, Gaston Memorial Hospital, Bowman-Gray, and Rowan Memorial Hospital. The firm is also negotiating contracts with six other hospitals. In introductory material about the clinical research services for the industry, Clindar claims "a major breakthrough for a clinical contract company by negotiating for placement of Clindar's Metabolic/Pharmacokinetic testing units directly in private hospitals and medical centers. The firm contends that the testing business provides benefits for the hospitals assuring "an additional revenue source that is recognized and identified within the hospital which does not require any additional capital expenditures." Clindar purchases from the hospitals all the support services that are needed to conduct clinical studies. Its press release notes that "these agreements make available the medical staff as principal investigators." The company also maintains that, in two of the contracting hospitals, normal volunteer units have been established so that bioavailability and bioequivalence studies can be performed.