The U.S. Army is soliciting for medical products development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) in their missions to develop and manage medical products to protect and sustain military personnel.
These organizations develop and field new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the Department of Defense, and maximize survival of medical casualties on the battlefield. This includes medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents.
The objective of the IDIQ contracts is to facilitate the timely and efficient execution of the US Army’s medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including:
- Project management
- Technical expertise/assistance
- Strategic planning
- Market analysis
- Training and administrative activities
- Pharmaceutical manufacturing and testing
- Assay validation
- Validated storage and shipment
- Non-clinical testing
- Clinical research
- Regulatory writing and submission support
- Regulatory strategy and consultation
- Integrated logistics support
- Equipment maintenance support
- Information technology
A task order, for example, may specify that a contractor will conduct clinical trials worldwide, provide product managers with technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system, safety pharmacovigilance and surveillance, and complete a final clinical study report.
The Period of Performance for this contract will be a five year base period with five one-year option periods. Further details are available under Solicitation Number: W81XWH-13-R-0038.