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BCGI® - Your Virtual Pharmaceutical Research Company
by Stuart L. Scheiner, MS, MD

What is a virtual pharmaceutical research company?
A consultant organization capable of providing all the necessary personnel and procedures to successfully conduct pharmaceutical research and development leading to product approval under FDA guidelines and regulations.

Why is it needed?
In this era of corporate downsizing and escalating costs of maintaining a full complement of qualified in-house research personnel, the needs of pharmaceutical companies both large and small often do not match availability. Research projects are sometimes either delayed or abandoned because of other urgent corporate commitments. Increasing numbers of new chemical entities demand rapid screening and, if promising, rapid development. Smaller high technology companies often have an immediate need for a clinical research infrastructure. There may be difficulties in identifying or recruiting investigators. Delay in product development may be due to the temporary lack of available personnel to develop research protocols or comprehensive case report forms that are data retrieval friendly. Sometimes delays in data entry and analysis occur because of competing priorities. These same competing priorities may hold up the preparation of study reports and product submissions for approval. Finally, after product approval, marketing may be impaired because a low priority must sometimes be assigned to Phase IV and Quality of Life studies.

How can BCGI® help fulfill your R&D requirements?
BCGI® has an experienced research and development team available to work with you in all phases of product development from the pre-IND stage to the post-marketing period. This team has had extensive experience in the pharmaceutical industry and includes seasoned personnel in the areas of developmental planning, regulatory affairs, medical monitoring, data entry and analysis, medical writing, and quality assurance. A regional monitoring system is in place ready to assure quality study conduct and regulatory compliance. BCGI® has a long record of successful interaction with the FDA. There are no low priority projects at BCGI®. And in order to meet urgent developmental requirements, BCGI® uses the latest technology available to accelerate completion of clinical trials.