DEADLINE: 15TH NOVEMBER, 2024
CENTRE FOR CLINICAL TRIALS, RESEARCH & IMPLEMENTATION SCIENCES (CCTRIS)
REQUEST FOR PROPOSALS (RFP) FOR EXTERNAL MONITORING SERVICES FOR THE AZIN-V-TRIAL
The Centre for Clinical Trials, Research and Implementation Science (CCTRIS) at the College of Medicine, university of lagos invites proposals from qualified and experienced organizations or individuals for the role of external monitors for the AZIN-V trial.
OBJECTIVE OF THE RFP:
1. The purpose of this request for proposals (PFR) is to enter into a contractual agreement with a successful bidder and select a suitable contractor to monitor activities related to the AZIN-V trial.
2. CCTRIS is a not-for-profit clinical trial unit 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 set-out requirements, while ensuring a high level of services.
ABOUT THE AZIN-V TRIAL:
The AZIN-V trial is a multi-center, cluster-randomized, hybrid type II effectiveness-implementation study aimed at assessing the use of oral azithromycin in labor to prevent maternal sepsis among pregnant women undergoing vaginal delivery across six Nigerian States, involving 48 study sites (health facilities) and approximately 5040 participants.
SCOPE OF WORK:
External monitors will be responsible for:
1. Ensuring compliance with Good Clinical Practice (GCP) and study protocols.
2. Conducting site visits to review trial procedures, data collection and participant safety.
3. Providing regular reports on trial progress and compliance.
4. Addressing protocol deviations, adverse event reporting and ensuring overall trial integrity.
DATA INTEGRITY SOURCE DATA VERIFICATION ON (SDV):
1. Ensuring that the data entered into the electronic data capture (EDC) system (REDCap) is complete, accurate and in line with source documents.
2. Implement risk-based monitoring approaches to focus on critical trial elements such as patient safety, data quality and compliance.
3. Prepare detailed monitoring reports after each site visit, highlighting findings, deviations, corrective actions and any necessary follow-up
4. Monitor the implementation of CAPA plans for any issues identified during site visits, ensuring corrective measures are effective and sustained
REQUIREMENTS:
a. Proven experience in monitoring clinical trials, especially in maternal health and/or infectious disease studies.
b. Familiarity with GCP (ICH E6 R3) guidelines and Nigerian Clinical trial regulations.
c. Strong data management and reporting skills.
d. Ability to travel and work across multiple sites in Nigeria.
e. Experience in trial monitoring for large-scale, multi-site clinical studies.
PROPOSAL SUBMISSION:
Interested organizations or individuals should submit the following
- A detailed technical proposal outlining relevant experience and approach to trial monitoring.
- A financial proposal with a detailed breakdown of costs.
- CVs of key personnel who will be involved in the monitoring.
- Evidence of precious clinical trial monitoring experience, particularly in Nigeria or similar settings
DEADLINE FOR SUBMISSION:
15th day of November, 2024
HOW TO APPLY:
Proposals should be submitted electronically as a single zipped file to info@azinvtrial.com with the subject line “RFP-AZIN-V Trial External Monitoring”.
FOR FURTHER INFORMATION, PLEASE CONTACT
+2348022496336 or +2348081107179
