MMV, DNDi and GARDP invite organizations to submit information on Artificial Intelligence (AI) solutions supporting clinical study design and medical writing.  

This Request for Information (RfI) aims to map the current landscape of AI capabilities, use cases, and providers that can improve the efficiency, quality, and consistency of clinical trial design and documentation. 

Objective 

  • Identify AI tools and solutions for Protocol Design and Optimization, Clinical Operations and medical writing
  • Assess capabilities, maturity, and deployment models
  • Identify potential partners and service providers
  • Inform potential future RfPs or collaborations 

Scope of Interest 

MMV, DNDi and GARDP are focusing on five priority areas: 

  1. Protocol Design and Optimization: 

Development of malaria trial-specific endpoints, inclusion and exclusion criteria, visit schedule optimization to reduce burden on patients and investigators, and identification of risks that may lead to protocol amendments. 

  1. Clinical Operations: 

Development of CDISC TMF-compliant study manuals and other operational documentation to support protocol implementation in malaria-endemic countries, including low- and middle-income settings. 

  1. Medical Writing:  

Drafting of key study documents, such as protocols, informed consent and assent forms adapted to country-specific terminology and language, protocol-required PRO questionnaires, and regulatory-compliant clinical study reports. 

  1. Product Development Documents:

Drafting and revising of key documents such as Investigator Brochures, integrated Development Plans, development Risk Management Plans.

  1. Other Relevant AI Capabilities: 

MMV, DNDi and GARDP also welcome information on other AI-enabled solutions or approaches that may address any other clinical operations’ needs in ways not explicitly described above.

Submission Process 

  • RfI Instructions HERE   
  • Answer Format: Microsoft Form Questionnaire HERE
  • Issue date: 9 September 2026
  • Deadline for questions: 15 September 2026
  • Closing date: 7 October 2026

Submissions should be concise and focused on relevant capabilities

Important Notes 

  • This is an RfI only (not a tender or commitment to procure)
  • Information will support landscape assessment and planning
  • MMV/DNDi/GARDP may contact selected respondents for follow-up discussions