Clinical and Regulatory Affairs for OASD/Health Affairs

The solicitation has been released and is posted at the Natick Contracting Division's website at https://www3.natick.army.mil.

The U. S. Army RDECOM Contracting Center, Natick Contracting Division, Natick, MA on behalf of the DoD Centers of Excellence for Psychological Health and Traumatic Brain Injury (TBI) has a requirement for clinical and regulatory commercial services. The contractor will oversee the process for Food and Drug Administration (FDA) Investigational New Drug (IND) and pre-IND efforts, including document preparation for FDA IND meetings, associated with the study for hyperbaric oxygen treatment of military personnel with psychological health or traumatic brain injury indications. This includes responsibility for quality assurance review of biostatistical analysis of the study and representation of such at pre-IND FDA meetings. Travel, estimated at 35% of the time, is required to sites throughout the country to educate study site personnel on study protocol and compliance. Minimum requirements include demonstrative record as a subject matter expert in clinical study trial design and implementation; experience with submission of INDs and FDA-regulatory aspects of multi-center clinical trials with regulatory compliance; significant involvement in at least one randomized clinical trial within the last 24 months which was completed and results published in a peer-reviewed journal; and completed relevant post-doctoral professional training. However, please note the solicitation will indicate the required knowledge, skills and abilities for this effort. This effort is a program under the Office of the Assistant Secretary of Defense for Health Affairs. A Firm Fixed Price contract is anticipated. The government anticipates a one-year base period, with a one year option. The estimated start date is July 2009. This procurement is 100% set-aside to small businesses. The small business size standard for this procurement is a firm having as their average annual gross revenue over the last three years of less than $7,000,000. The government anticipates the solicitation document will be released on or about June 5, 2009. The above noted Response Date is the date the government anticipates offers will be due. Questions concerning this notice should be addressed to Mr. Thomas Bouchard at Thomas.Bouchard@us.army.mil.