The World Health Organization (WHO) invites interested and suitable contractor(s) to indicate interest by submitting RFP documents for the following works:
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of health".
Applications are invited for:
Title: Request for Proposal (RFP) Data Management Platform for a Clinical Trail
The purpose of this Request for Proposals(RFP) is to enter into a contractual agreement with a successful bidder and select a suitable contractor to provide data management services for a multi-country, multicentre phase 3 randomized clinical trial (The STEP-Mag Trial).
WHO is an Organization that is dependent on the budgetary and extra-budgetary contributions it receives for the implementation of its activities. Bidders are,therefore,requested to propose the best and most cost-effective solution to meet WHO requirements, while ensuring a high level of service.
- Proven experience in the field of statistics and data management.
- Previous work with WHO, other international organizations and/or major institutions in the field of clinical trial data management.
- Experience in clinical trials related to maternal or perinatal health.
This RFP calls for bidders on the creation and management of this data base, per the requirements listed below. The bidder is requested to provide an offer for the internal pilot (Phase 1) and a second offer for continuation into Phase 2. Progression into Phase 2 will be determined by the trial data and safety monitoring committee and the TCU. Bidders are duly informed that a contract for Phase 2 is contingent on satisfactory performance of services of Phase 1:
Application Closing Date
- To create a GCP compliance database for entry of data elements and data validation consistent with the CRF developed by the STEP-Mag Trial Coordinating Unit (TCU; HRP/MPH as Secretariat). The database shall have safeguards to ensure the authenticity, integrity, and confidentiality of electronic records; with controls to ensure that key elements such as signatures cannot be copied, falsified, or manipulated; controls to maintain authorized access and security of passwords/identification codes, etc. In addition, please see Appendix 1 for reference.
- To host and maintain the server, update the database in case there is a requirement during the study period & provide technical support to the country sites.
- To provide data entry and data management training and support to country sites including training documents (Manual to use the system, SOP and video support training)
- To support SDV activity. To interact with the data monitoring contractor, as requested by the TCU.
- To conduct regular monitoring the quality of data entered into the database by the country sites and perform data curation: manage the data entered into the database by the country sites, generate and communicate queries from both the DM system and external validation with the sites and follow-up with query resolutions.
- Produce monthly study progress report to send to WHO TCU and Country PIs
- To prepare interim and final statistical analytical plans
- Return all material and data to the WHO TCU at study closure.
5th January, 2022.
Submission of Documents
The bidder shall submit the complete proposal to WHO via email at: firstname.lastname@example.org
Each proposal shall be marked Bid Ref "UHL-SRH_STEPMag_Data" and be signed by a person or persons duly authorized to represent the bidder, submit a proposal and bind the bidder to the terms of the RFP.
For more clarifictions on this RFP, please Click Here
Related Document: Cybersecurity Requirements