Protocol Finalization...
	Investigator Identification...
	Prelaunch Investigator meetings...
	On-site, and In-house Clinical Data Monitoring at No Less Than Monthly Intervals...
	Data Review and Management with Constant Study Progress Reporting...
	Assurance of complete HIPAA compliance of any clinical program.

Selection of Appropriate Clinical R&D Services

While all of the above services are available, it may not be necessary to utilize the entire R&D process for the solution of your problem or the realization of your research and development goals. In certain circumstances, where protocols already exist or are conceptualized, it may not be necessary to use an Expert Review Panel. The actual performance of a clinical study or program is all that need be initiated.

All of the previously mentioned services are available individually or in any combination.

Clinical R&D Services’ Regulatory Interface Policy

Clinical R&D Services’ staff members and the members of the Expert Review Panels are available to review and discuss their findings with the Federal Regulatory Agencies at your request.

Time Performance

Any agreed upon program may be conducted on a guaranteed time-performance basis if desired and specified prior to commencement.

Areas Of Clinical R&D Services Application

Clinical R&D Services is a valuable supplementary source of manpower to your research group in the following areas:

CLINICAL NEW DRUG DEVELOPMENT Performance of Phase I, II, III and IV (marketing) clinical studies, including bioavailability and special studies...individually, in groups or as a total package...through NDA submission...and beyond...

RX TO OTC SWITCHES Classic and current state of the art methodologies can and have been applied to moving current prescription products to over the counter (OTC) status. This includes the “naturalistic” type of clinical trials in one to one hundred or more sites simultaneously across the country...

PRODUCT DEFENSE Ethical, OTC products...Expert Review Panel Position Papers...Evaluation of FDA submissions...design and/or performance of needed additional clinical studies...

MEDICAL DEVICES In light of regulatory legislation and corporate streamlining, clinical development of new or existing medical devices can be undertaken while assistance is given to aid you in the development of your own clinical research capabilities, if necessary...

COSMETICS With further federal regulation of the cosmetic industry to come, assistance can be given in such areas where product claims must be verified or ingredient safety must be substantiated.

ONGOING CLINICAL TRIALS Clinical R&D Services has the ability to assume control and management of clinical trials already in progress. This provides you with the flexibility to utilize your own staff resources for other tasks that may be more pressing, while allowing the timely continuation and conclusion of critical ongoing projects and programs.