Electronic Quality Management System (eQMS) and Electronic Trial Master File (eTMF)

Awarded as a Time and Materials purchase order.
Rationale: It was not possbile to estimate accurately the extent or duration of the work to anticipate costs with any reasaonble degree of confidence. For the cloud-based Software-as-a-Service, the number of required licenses could vary significantly, especially in the first year of operation. Consumption-based payment is a fundamental component of cloud computing and the subscriber pays according to was is consumed. If NIAID utilized Firm Fixed Price (FFP) for these subscriptions, NIAID would either have to set aside a large amount of funds for corresponding services it may never fully consume or set aside too few funds that may not cover NIAID's actual service consumption. To solve the funding challenge, NIAID would utilize a Time and Materials contract for cloud computuing services and establish a ceiling that would easily accommodate maximum usage. The professional services effort required to configure the System is highly dependent on the current and desired states of the participating Division's processes. Since these processes are no consistent across divisions no are they well-defined, NIAID believes that respondents may submit high FFP quotes in order to minimize their risk of overruns. In addition, the lack of well-defined target configurations increases the possibility of the Contractor claiming that key tasks are out-of-scope. This acquisition attempted to maximize the use of FFP. However, a fixed number of hours cannot be determined for the labor but only estimates can be developed based on conversations with Industry and NIAID's experience with similar projects. Once the System is in production operation, NIAID anticipates future services to support the system could be FFP.. Awarded Vendors: Dovel Technologies LLC. Contract Award Dollar Amount: $6,987,701.50 (ceiling includes all options). Contract Award Date: 2019-09-24.