Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
UsernamePublicRestriction

Register

PS008365

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel