The search for life sciences solutions to the COVID-19 crisis
Supporting CROs that are working tirelessly and providing value to the clinical trial community using technology and science to help researchers tackle this deadly pandemic.
The novel coronavirus (COVID-19) pandemic is an unprecedented crisis that has galvanized the global scientific community around the search for a viable vaccine and effective therapies. This incredible commitment to science may ultimately pay dividends, but each passing day is critical as we seek to stem the tide of this deadly pandemic.
While the clinical trial process can sometimes appear long and arduous, the current global pandemic has validated the need to reset the clock. There is a collective sense of urgency to consider incremental ways to expedite the process to get treatments to patients and our IBM® Clinical Development (ICD) solution is designed to help address a challenge such as this.
ICD is a unified, SaaS-based electronic data capture (EDC) platform, designed to provide end-to-end visibility as well as patient, site, and clinical trial management capabilities. ICD is designed to help clinical trial sponsors and clinical site staff reduce the time and cost of clinical trials by centralizing and organizing information, providing 24/7 access to clinical trial data via a single URL from any web-enabled device, and providing a flexible and scalable data management platform to help design and manage clinical trials by incorporating optional clinical trial-specific features and services.
When there were early indications that COVID-19 was spreading in China, IBM announced that we would offer the ICD solution free of charge to eligible trial sponsor organizations as part of our efforts to help support the medical community to address COVID-19. As the virus spread, we expanded the offer and made it available worldwide. Not surprisingly, there was interest from numerous sponsors, contract research organizations (CROs) and academic institutions across the globe.
To date, we are proud to say that we are currently enabling 10 COVID-19 trials with quite a few more in the pipeline. We believe in the promise of science and are inspired by the efforts of these committed CROs.
One such partner, Veristat, a leading global CRO, is supporting several COVID-19 trials with ICD. One, an open-label trial for an anti-viral treatment that Veristat got up and running in just two weeks. Another, a phase I vaccine trial where the database was designed and built in 10 business days by Veristat to allow patient randomization to begin immediately. Veristat relied on the ICD randomization modules as well as Lab Normals, SmartReport, and other aspects of the ICD platform. The speed at which these trials were initiated challenges industry standard time which is significantly longer.
“The IBM Clinical Development solution enabled us to launch these critical studies under extraordinarily aggressive timelines. We utilized the randomization module to help sites quickly enroll and randomize the patients through an integrated system within the unified, cloud-based EDC platform. We leveraged our own experience and library of eCRFs across programs and existing COVID-19 studies to easily copy portions of database build,” explains Cindy Henderson, Executive Vice President of Strategic Development at Veristat. “ICD allowed us to achieve these accelerated timelines because it offers quick and easy study builds, the ability for split releases, and easy setup of additional modules integrated within the system – all supported by IBM’s ability to be extremely agile with near real-time updates to the system.”
Similarly, MMS, a global, data-focused CRO has established the ambitious goal of building and launching integrated datasets for sponsor trials within three business days. As part of the global therapeutics accelerator effort, MMS is supporting multiple studies around the world including a promising trial that is studying novel agents among high risk outpatients in adults across three geographies.
“The IBM Clinical Development solution is a critical resource in our efforts to quickly design and launch trial databases at a time when speed, efficiency and agility are critical. The fact that it is a cloud-based platform is a critical success factor – we can move quickly through our database platform and can safely and securely access the data from anywhere including remotely from our homes,” explains Mindy Wolf, Manager of Program and Account Management at MMS.
In Brazil, AZIDUS Brasil CRO and Cellavita™ Research Lab are using the ICD to help advance clinical development in the battle against novel coronavirus. The protocols involve the study of effectiveness of Nitazoxadina 600mg and also of a proprietary stem cell technology (NestaCell®) from Cellavita, that is designed to help address the inflammatory effects of COVID-19, with a focus on attempting to mitigate the severity and duration of the disease. “The IBM solution is being used in studies of great importance, in an attempt to help find new therapeutic alternatives for the treatment of COVID-19”, explains Luciana Ferrara, AZIDUS Brasil CEO. “We feel a sense of urgency to identify meaningful therapies that could help support patients, particularly at a time when we are seeing the crisis escalate in Brazil. We are relying on our collaboration with IBM to help bring greater efficiency to the clinical trial process.”
While our solutions play a critical role in supporting the success of these innovative and driven CROs, we believe that collaboration is a strategic success factor. These CROs are working tirelessly and providing value to the clinical trial community and we are proud to be a valued resource in this effort, using technology and science to help researchers tackle this deadly pandemic. We believe that this united front and relentless innovation offers great hope for meaningful medical advancements in the weeks and months ahead. This pandemic has shed a spotlight on the power of science to transform society and we will continue to offer solutions that can help support the scientific community in this fight.