Consultant to provide GCLP/GCP audit services for Unitaid projects

Switzerland
Apply by 12 October 2018
Senior-level , Field assignment
Posted on 2 August 2018

Job Description

Unitaid is seeking the expression of interest (EOI) from individuals, firms or institutions that are capable of, and would be willing to, support Unitaid on the Good Clinical Laboratory Practice (GCLP) and/or Good Clinical Practice (GCP) review and audits or its research-oriented projects.

Please find attached our detailed requirements and instructions on the expression of interest.

All queries pertaining to this EOI should be addressed in writing to unitaid-proc@who.int.

EOI Timeline:

Request for clarification: 21 September 2018 @ 17h00 Geneva time

Submission of EOI (by email to unitaid-proc@who.int): 12 October 2018 @ 17h00 Geneva time

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Objectives

In order to strengthen the assurance of Unitaid’s research-oriented projects and ensure compliance with WHO’s requirements of ethical research, this Expression of Interest aims to identify potential service providers that are capable of conducting evaluations and audits of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) in selected clinical trial sites in middle-income-countries (MICs), low-middle-income-countries (LMICs) and low-income-countries (LICs) as part of Unitaid’s overall assurance and oversight of the Human Subject Research (HSR) conducted by its grantees in Unitaid-funded research projects.

Potential Scope of Work

  1. Review/Define an approach on the GCLP/GCP requirements of Unitaid within its grants.
  2. Provide support to establish appropriate GCLP/GCP monitoring and reporting setup and requirements between the Grantee and Unitaid.
  3. Review of monitoring reports and key findings of GCP monitoring submitted by the research sponsor and grantees to assure GCP in place.
  4. Assess study adherence to International Conference on Harmonization (ICH) Harmonised Tripartite Guidelines, Good Clinical Practices (GCP)/Good Clinical Laboratory Practice (GCLP), national regulatory requirements for clinical development, and other relevant guidelines (World Medical Declaration of Helsinki, World Health Organization, etc).
  5. Assess risks and mitigation plans.

Please refer to the REOI document for more details.

About the Organization

WHO is a public international organization, consisting of 194 Member States, and a Specialized Agency of the United Nations with the mandate to act as the directing and coordinating authority on international health work. As such, WHO 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.

Unitaid was established in 2006 by Brazil, Chile, France, Norway and the United Kingdom in the context of the fight against HIV/ AIDS, tuberculosis and malaria in resource-limited settings, with a focus on health products.

Unitaid's mission is to maximize the effectiveness of the global health response by catalyzing equitable access to better health products. Unitaid's interventions promote innovation in developing new products and approaches, increase access by leveraging its market expertise to overcome access barriers and create the right conditions for scale-up, so that better health products reach all people who need them, with priority given to the underserved and the poorest populations.

The principal functions of the Secretariat are to carry out and manage the day-to-day operations of UNITAID/WHO, including implementing the work plan of UNITAID/WHO as approved by the Board, managing and coordinating relationships with Partners, and coordinating and facilitating technical support and advice to the Board. UNITAID is supported by public funding and is hosted by WHO.

Please consult our website at the following link for more information https://unitaid.eu/ .

More information

2018.13 - EOI for GCP Audit.docx
2018.13 - EOI for GCP Audit.pdf