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The Clinical Technology Transfer Group, P.L.L.C. (CTTG)
provides a unique resource for legal advice and counseling on the clinical
development of drugs, medical devices, and dietary supplements. CTTG's practice focuses on technology transfer and regulatory compliance in the clinical setting.
By concentrating in these practice areas, CTTG offers clients a focused,
experienced resource on the legal, regulatory, and ethical issues affecting
clinical research.
CTTG was established in early 2004, and while the firm is new, our attorneys
have over 60 years of combined experience in the health care field. All
of our attorneys chose law as their second career and bring to our firm
years of practical experience in the basic sciences, technology transfer,
clinical research, and the development and marketing of dietary supplements.
Our experience includes work in start up biotech companies, major medical
research centers, the National Cancer Institute, and the dietary supplement
industry. We are able to combine this experience with our legal training
to provide clients with practical advice and assistance on their clinical
development projects.
CTTG’s attorneys have extensive expertise in
technology transfer issues. As technology transfer professionals at
the National Institutes of Health, they assisted government scientists
and researchers to establish partnerships with industry collaborators
for the development of a wide range of technology. In private practice
they have helped companies in the pharmaceutical, medical device, and
dietary supplement industries negotiate Material Transfer Agreements
(MTAs), Clinical Trial Agreements (CTAs) and Cooperative Research and
Development Agreements (CRADAs) with the federal government. They are
active affiliate members of the Association of University Technology
Managers (AUTM) and are knowledgeable about the technology transfer
issues related to government funding agreements.
CTTG attorneys have extensive experience assisting clients in understanding
and complying with the federal and state laws and regulations governing
the conduct of clinical research. Their experience includes drafting and
negotiating clinical trial agreements and investigator and site agreements,
as well as providing regulatory review of informed consent documents.
Strategically located in the Washington, D.C. area, CTTG follows current
developments in clinical research by attending federal advisory committee
meetings, congressional hearings, and major national conferences to ensure
that our clients are kept abreast of evolving issues in clinical research.
CTTG attorneys also have extensive experience in the
legal and regulatory issues affecting the development and marketing
of dietary supplements. CTTG attorneys routinely advise companies on
a wide range of issues related to the formulation and marketing of dietary
supplement, botanical, and “functional
food” products to ensure compliance with federal standards for manufacturing,
safety, and labeling. CTTG applies this experience to assist clients develop
and implement a rational approach to clinical testing of their products,
particularly with respect to new dietary ingredients and claims substantiation.
Our mission is to provide a reliable, high quality, and
cost effective option for legal advice and counseling on technology transfer
and clinical development projects. Call us at (703) 734-0484.

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