DataFit Systems Operations and Maintenance Support Services

The U.S. Food and Drug Administration (FDA) hereby issues a notice of intent in accordance with FAR 5.201. Pursuant to FAR 6.302-1, the FDA will sole source with Pinnacle 21, LLC., 531 Playmouth Rd, Ste 508, Plymouth, PA 19462-1642 for the operations, maintenance and enhancement of the DataFit program, FDA's data validation system. Pinnacle 21 is the only contractor able to meet the requirement of this procurement. The FDA intends to award a five (5) year Indefinite Delivery, Indefinite Quantity (IDIQ) contract to Pinnacle 21 for the Pinnacle 21 (P21) Enterprise software license and operations, maintenance and enhancement of the DataFit program. Pinnacle 21 is the sole owner, seller and developer of the P21 Enterprise software that performs the data validation for the DataFit program. DataFit validation of electronic clinical and non-clinical study submission data is a mission critical component of the FDA's JumpStart service. DataFit is the FDA platform for standards compliance and data-quality evaluation of electronic submission data. The DataFit custom installation version of P21 Enterprise is the only system currently capable of meeting FDA's data fitness assessment needs. Pinnacle 21 is a CDISC technology partner which enables them to provide validation updates in sync with the CDISC standards. The NAICS code is 518210, Data Processing, Hosting, and Related Services. This notice of intent is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Alicia Baltimore at the email address below by noon on April 15, 2021. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. If no responses are received, the FDA will proceed with the sole source award to Pinnacle 21, LLC., 531 Plymouth Rd, Ste 508, Plymouth, PA 19462-1642. The anticipated award date of this purchase order is on or about April 30, 2021. If you have any questions regarding this announcement, please contact Alicia Baltimore at via. email [email protected]