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Clinical Trial Sites and Laboratories Network

The main objectives of Work Package Two are:

Identify parameters and standards

Identify and set parameters and standards for mapping and capability assessment of clinical sites and laboratories.

Governance of sites

Establish systems for coordination, collaboration and governance of the sites, laboratories and (sub)networks.

Assess capabilities and focus areas

Conduct mapping and landscaping desktop research to identify existing (networks of) clinical sites and laboratories and assess their capabilities and disease areas of focus.

Improve CTC platform

Improve the CTC platform as a common, central electronic registry for the network and subnetworks of clinical sites and laboratories.

Description of Work

What and Why

  • Create a network of subnetworks that will foster coordination in clinical research, by ensuring and encouraging alignment in disease area prioritization, raising awareness and visibility of existing capacity from sites and labs across Africa, operationalising the regulatory processes across the region, and strengthen less experienced sites and labs through a clinical trial preparedness framework.

 

Goals

  • Identify and set parameters and standards for mapping and capability assessment of clinical sites and laboratories.

  • Establish systems for coordination, collaboration and governance of the sites, laboratories and (sub)networks.

  • Conduct mapping and landscaping desktop research to identify existing (networks of) clinical sites and laboratories and assess their capabilities and disease areas of focus.

  • Improve the CTC platform as a common, central electronic registry for the network and subnetworks of clinical sites and laboratories.

Activities

  • Task 2.1: Define and validate criteria and standards for mapping clinical sites and labs and assessing their capabilities. (An additional joint exercise with members of the consortium and the EAB (External advisory board) [including WHO-Africa, AUDA-NEPAD (African Union Development Agency - New Partnership for Africa's Development), AMA (African Medicines Agency), WHO-AVAREF (African Vaccine Regulatory Forum) and Africa CDC (Africa Centres for Disease Control and Prevention)] will be conducted to identify priority disease areas and related capabilities, agreed upon criteria such as country-specific needs, which will further refine the mapping requirements.)

  • Task 2.2: Create the CTCAN network implementation plan.

  • Task 2.3: Map and assess clinical sites and laboratories.

Expected Outcomes

  • An ever-present and ready-to-go pool of clinical research sites and labs with the agility to rapidly address new and emerging global health threats, epidemics, and pandemics, thereby efficiently contributing towards clinical research in pandemic prepare.

  • Creation of a network implementation plan.

 

Freedoms

  • Ready networks that can be leveraged [EDCTP NOE (EDCTP Networks of Excellence), PANTHER, ALERRT (African coalition for Epidemic Research, Response and Training)]

 

Constraints

  • Limited resources.

Responsible Consortium Partners

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