The Mitchell Group
Temperature monitoring for investigational products to ensure a continuous cold chain for a controlled trial of Ebola virus disease (EVD) therapeutics in the RDC.
Customized support and a real-time temperature monitoring solution.
Successful remote monitoring of investigational products in politically unstable conflict areas of Democratic Republic of Congo (DRC).
Challenges of clinical trial for finding an effective therapeutic treatment against the Ebola virus
As part of ongoing research programs on EVD, the National Institutes of Health (NIH) worked with the Congolese National Biomedical Research Institute to conduct a scientifically rigorous randomized controlled trial (RCT) of EVD therapeutics.
The study was carried out in the North Kivu and Ituri provinces of the DRC during and in response to the country’s 10th EVD outbreak.
Four investigational products were investigated to treat Ebola-positive participants at sites in North Kivu, DRC.
Dr. David Vallée, TMG Research Pharmacist, supported the implementation of the clinical trial and collaborated with Koovea to establish the temperature monitoring capabilities for investigational products used in the RCT.
The whole team were faced with numerous challenges to ensure that the quality of the experimental treatment is assured as well as its potential effectiveness.
First, it was particularly difficult to maintain the cold chain during transportation due to the poor road infrastructure and insecurity as a result of the armed conflict.
Second, unstable electricity meant that the RCT teams had to procure external power supplies to ensure the uninterrupted cold chain of investigational products stored at sites in North Kivu.
Finally, healthcare workers and researchers from the INRB had to overcome these challenges to provide timely and safe care to patients while conducting an RCT to identify an effective treatment against EVD.
The findings of the RCT identified two effective experimental therapeutics against EVD. On 25 June 2020, the World Health Organization declared the end of the outbreak.
However, the COVID-19 pandemic and the recent 11th outbreak of EVD in the country illustrates the need for health care professionals to have the tools and equipment to ensure people have timely access to safe and effective treatments.
Our solution for clinical trials
KOOVEA’s K-TAG probes allows users to remotely measure and monitor the temperature of products during transportation and storage. The K-APP web-based application is a centralized monitoring system that provides users real-time alerts that are essential to supervise the cold chain of all products.
The RCT implementation team required a temperature monitoring system, so The Mitchell Group Inc. conducted an assessment of different systems and selected KOOVEA based upon the following criteria :
– adaptable solution that can be tailored to different settings
– customer support services to provide trouble shooting
– real-time data collection
– geolocation data
The results of the agreement
The Frederick National Laboratory for Cancer Research, currently operated by Leidos Biomedical Research, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID) approved the procurement of the KOOVEA system for the Ebola RCT being implemented in DRC.
Temperature monitoring using the KOOVEA devices allowed for continuous cold chain monitoring during shipping and in storage at the clinical sites which established the suitability for use of investigational products during the PALM 1 clinical trial, which was essential.
KOOVEA’s focus is on contributing to the improved management and medicines and provide easy to use equipment that ensures the quality, security and access, to medicinces for all people
The KOOVEA solution helps reduce costs in the pharmaceutical supply chain. It provides a simple, easy-to-use solution that provides users with reliable information to advance research their research needs in any setting.
“We have stopped losing investigative products. […], We have improved the quality of the clinical trials in the DRC in order to be in compliance with world standards for clinical research.” David Vallée, Doctor in clinical research pharmacy, of the PALM 1 clinical trial.”
PharmD, Master of Public Health