NIH NHLBI has issued a pre-solicitation non-competitive synopsis related to the award of a contract in support of the National Human Genome Research Institute (NHGRI).
The contractor shall “provide monitoring and data management services that will manage the NHGRI Clinical Director’s intramural monitoring and quality assurance program; establish, update and implement the SOP for protocol monitoring and quality assurance; prepare and enforce corrective and preventative action (CAPA) plans; lead NHGRI clinical staff training for FDA-regulated clinical trials; prepare informational materials for training; educate clinical staff on human research protection policy updates, verify data from NHGRI intramural clinical trials; verify NIH Clinical Center Pharmacy inventory records…”
“The intended source for this acquisition is Emmes Corporation. Emmes is uniquely qualified to perform this follow-on contract due to their expertise and experience in providing protocol development and data management services in the current order. The Office of the Clinical Director requires protocol monitoring and data management services in order to remain compliant with established regulatory guidelines.”
Responses are due by May 1, 2018.
