RFP and Configuration Requirements for Clinical Trial Tracking
Summary:
A CTRM solution combined with a new clinical trials management system was planned and the organization needed support to document requirements for an RFP and, once the vendor was selected, for the configuration of the system.
Client Profile:
- Largest research-based biomedical and pharmaceutical company in the world
- 100+ years in business
- Colleagues in over 150 countries
The Challenge:
The client needed support in developing requirements for a Request for Proposal (RFP) for a global Clinical Trial Relationship Management (CTRM) system as well as assistance in defining the configuration requirements for the chosen system.
The Solution:
Doreen Evans Associates, Inc. (DEA) was engaged to elicit, analyze, and document the requirements for this clinical trials management system initiative. DEA provided the following services:
- Managed the project and requirements process to ensure that the requirements effort was on time and within budget while producing a comprehensive set of both RFP and configuration requirements
- Facilitated workshops and information gathering sessions to elicit functional and non-functional requirements from global business users and subject matter experts
- Published the requirements to RequirementsLINK™ and managed a review cycle for all of the system stakeholders
- Generated a detailed configuration requirements specification document
- Participated in configuration requirements review and design sessions ensuring that the requirements were understood and implemented correctly
- Maintained approved changes to the requirements, assessed impacts and updated the requirements repository as necessary
DEA completed the initial requirements development for the clinical trials management system initiative and produced the final RFP document for the client. These initial requirements were further enhanced and developed with additional detail to provide the configuration requirements for the selected CTRM solution.
