FHI 360

FHI 360 (http://www.fhi360.orgis a world leading nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions.  FHI 360 conducts and supports clinical research in resource-limited settings around the world. In collaboration with global networks and partner organizations, they design, implement, manage and monitor complex studies, including multisite and multi-country clinical trials. They also offer their clients a full range of clinical research services that ensure efficient, cost-effective trials with reliable results.

They bring technical, regulatory and cultural expertise
and an established presence in regions where the need and opportunity for clinical research are greatest.  One of these regions is the western part of Sub-Saharan Africa, which has been ravaged by Ebola.  FHI 360 is supporting the CDC in clinical trials for an Ebola vaccine.   In Sierra Leone, the vaccine distribution process will be managed through one primary depot, two sub-depots, and approximately seven trial sites.  The vaccine is stored at and shipped from the main depot to the sub-depots at minus 80°C. The vaccine is stored at the sub-depot at minus 80°C.  Within 24 hours of administration, the vaccine is thawed, diluted, and filled into a syringe for dosing at the trial site. The filled syringe is shipped between 2°C to 8°C to the trial site.

  • Execute successful transition to new cold chain operation lead
  • Manage day-to-day operation of the distribution process to ensure vaccine is maintained at the proper temperature.
  • Address technical and operational problems associated with the distribution process as they occur.
  • Review and evaluate the current cold chain and distribution process.
  • Identify any potential issues and recommend possible remediation.
  • Create and execute a mitigation plan to address identified issues
  • Maintain distribution operations for the cold chain network.
  • Continuous improvement for current operations
  • Technical transfer of best-demonstrated practices for future cold chain clinical operations
  • Access to experience in preparing and managing distribution operations in extreme operating environments. 
  1. Execute transition plan.  Gathered all appropriate SOPs and policies.  Created and executed training plan prior to arrival in country.   Developed transition plan with current operations lead for review and approval by FHI 360.  Executed transition plan with cold chain operations leads.
  2. Conduct comprehensive GDP audit for cold chain distribution process.  Auditing is an integral part of the quality management system.  Once gaps were identified, corrective actions were put in place to address high priority observations. This is a powerful technique to make immediate improvements to the current process and reduce the likelihood of non-conformances.
  3. Conduct comprehensive Risk Assessment for cold chain distribution process.  Risk assessment is an integral part of the quality risk management process.  Once risks were identified and evaluated, mitigation plans were put in place to address significant risk events. The current product handling characteristics, logistics network, and packaging were assessed to identify opportunities to mitigate any patient safety, product quality, or regulatory compliance exposure.  Risk assessment allowed the prediction of failure modes and made a more robust distribution process.
  4. Execute cutover to new cold chain operations lead.  Assumed day-to-day operations after completion of transition plan, GDP audit, and risk assessment.
  5. Manage day-to-day operation of the cold chain distribution process to ensure vaccine is delivered to treatment sites.  Modality Solutions provides in-country, on-site support to manage the daily operation by ensuring all policies and procedures are adhered to, by implementing continuous improvement activities, and by completing audits, reviews, quality documentation, and chain of custody as required.  In addition, we provide training as needed to employees and maintain vaccine inventory logs.
  6. Provide technical assistance in support of the cold chain distribution process. Conduct root cause failure analysis as needed. Investigate non-conformances, implement corrective actions, address process or operating problems with the distribution process. 
  • Executed and documented training plan on all appropriate SOP's and policies
  • Audit report and all appropriate steps documented in the quality management system.
  • Comprehensive risk-based assessment and all appropriate steps documented in a Risk Management report in the quality management system.
  • Implemented mitigation plan associated with the assessment
  • Critical to Quality metrics reported on weekly basis for the cold chain distribution process including chain of custody, temperature control and on-time delivery.
FHI 360
Proposal 120 
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 Nonconformance reports, trending analysis, and CAPA documentation when required, to demonstrate successful resolution of technical issues associated with the cold chain distribution process.