If you're involved in clinical investigation of therapeutic agents in oncology, cardiology, HIV/AIDS, Rheumatology or infectious diseases, chances are you're already aware of GSCC Clinical Research.

Our MSLs are there to help initiate and carry out Phase IV clinical trials services. They are a manifestation of Global Services Clinical Consulting, LLC commitment to provide the healthcare community with quality and services. They also play a role in our corporate service development to our clients.

WHO ARE THEY?

GSCC MSLs come from a variety of backgrounds, for example, pharmacy, academia and clinical research. Each contributes unique perspectives.

MSLs are selected as much on the basis of their personal and professional qualities as for their experience: honesty and integrity; innovation and creativity; dedication to excellence; a sense of urgency; and excellent interpersonal and administrative skills.

WHY ARE THEY NECESSARY?

To meet licensing requirements, clinical trials of new therapeutic agents must focus on FDA-defined primary endpoints. But these studies may fail to address or yield incomplete information on other key clinical questions - such as rejection incidence, optimal dosing, efficacy and safety in combination with other new agents, drug interactions, and potential for use in other patient types or indications. Physicians working daily in the fields know what factors are crucial in deriving the greatest benefit from a new therapy. That's where MSLs come in, interacting with investigators to fund, develop, implement and manage research into these interesting and important clinical issues.

WHAT DO THEY DO?

MSLs play a significant role in GSCC clinical research projects - usually Phase IV trials of products that have been cleared for marketing FDA. They may do any or all of the following:

> Manage study contracts, Payments and grants

> Assist in protocol and forms development

> Ensure timely availability of study supplies

> Assist in study initiation, patient enrollment, management, monitoring, data collection and analysis

> Liaise with CRO's study sites and sponsors

> Facilitate study reporting and publication

ORGANIZED FOR ACTION

MSL activities are integrated and coordinated at two levels. The group itself is formed into several Field Project Teams, each responsible for all MSL activities within one of the following therapeutic areas:

Oncology

Cardiology

Infectious diseases

Rheumatology

Autoimmune diseases

The Field Project Teams submit all proposals for new studies to an MSL Project Team comprising, in addition to MSLs, representation from various GSCC departments, including Drug Development and Project Management, Research and Development, Medical Affairs and Marketing. This group meets monthly to consider new study proposals and be updated on ongoing trials.

CONTINUING EDUCATION SERVICES

MSLs review the current medical literature and attend medical and other relevant meetings to maintain and expand their professional knowledge. You can count on their capacity to understand and help. Extensive Knowledge of clinical therapeutic in their assigned areas equips them to perform valuable educational services, such as staff training, presentation of research data, and in-services.

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