The Department of Defense (DoD), Defense Health Agency (DHA) is issuing this request for information as a means of conducting market research to support the requirements to provide the Public Health Division (PHD) Immunization Healthcare Division (IHD) support for vaccine safety and evaluation studies as well as management of the related IT health systems applications…
Requirements: Provide support services in the areas of protocol development, regulatory approval and sustainment subject recruitment and enrollment, data entry and quality control, data management, abstraction and validation, statistical analyses, biospecimen processing, shipment and storage, and generation of publications and presentations in support of clinical investigations projects related to the safety, acceptability and effectiveness of immunizations within the military and beneficiary population. Additional support services include development and implementation of healthcare-related information management systems, equipment and services, and systems design for data capture generated by clinical investigations. All study activities will be performed in strict accordance with applicable protection of human subjects regulations, and all clinical investigations records will be in compliance with applicable regulations and Institutional Review Board approved clinical investigations protocols.
3.1 Clinical investigations projects support
3.1.1 Recruitment and Enrollment: Contractor shall recruit potential study subjects, and determine initial eligibility for participating in study protocols. Contractor shall enroll subjects in clinical studies protocols. Contractor shall review and obtain informed consent from the subjects prior to enrollment in the clinical investigations protocol. Contractor shall coordinate and conduct study subject visits and assure all procedures are conducted in compliance with the clinical study protocol.
3.1.2 Specimen Collection and Handling: Contractor shall obtain specimens via venipuncture and other methods, as required per study protocols. Contractor shall perform vital signs and other necessary clinical procedures as dictated by clinical investigations protocols. Contractor shall perform specimen handling and processing, to include but not limited to drawing blood, obtaining saliva samples, and storing and/or shipping such samples to external collaborators, as required per study protocols. Contractor shall obtain laboratory testing as required. Contractor shall maintain inventory of clinical investigations project specimens and detailed audit tracking of the movement of specimens.
3.4 Support for information technology needs of IHD:
3.4.1 With close coordination and direction of IHD Government civilian employees, contractor shall plan, define, develop, revise, and implement healthcare information management systems, equipment and services with COR coordination, review and approval (with approval by the CO when necessary) to benefit the Clinical Investigations section and other sections within IHD. Contractor shall provide secure solutions to complex data management and reporting challenges, including but not limited to, creating data forms, clinical data tracking systems, development of online survey distribution tools, etc. Contractor shall provide project management, design, and programming for existing data management and analysis tools used by the IHD, including but not limited to:
- VAECS: Vaccine Adverse Events Case Management Module
- DoD Call Center Module
- Specimen Tracker Management Module
- DH-PHD-IHD Research Management Module
- ADHOC Clinical Data Cube Reporting Module…