Co- authored by : Niteshkumar Dixit
These are unprecedented times. The world is mobbed by a contagion virus, putting people’s health at risk, threatening to destabilize economies. It has already put global healthcare systems under tremendous pressures, and managed to resist efforts to contain it. Even though coronaviruses are not new, this COVID-19 strain has created panic and forced us to be locked down in our homes sans any movement for weeks, if not months. Organizations are fighting an intense battle to keep their workforce safe, minimize risk, and ensure business continuity. For the Life Sciences industry, however, the challenge is even more significant. The whole world is looking at them to come up with a vaccine and a cure. But that is easier said than done. Bringing a new drug to market is an uphill battle and requires rigorous clinical trials. This process already has regulatory challenges. With the current lockdown situation, the Pharma community is grappled with the challenge of continuing some of the critical and time-sensitive in-flight trials so that their regulatory submission, registration, and market entry are not impacted. But all may not be lost. With the right technology solution, it is possible to turn the situation around rapidly.
Life sciences and healthcare industry do need support in not only keeping the lights-on but develop effective solutions to scale clinical research and medical product engineering for rapid mobilization and desirable outcomes.
Tweaking the Present for a future New-Normal
Medical and clinical research companies were already struggling to improve their products’ risk-reward profile (pharmaceuticals and medical devices, diagnostics), be relevant, and retain their top lines. However, the current situation casts a grave threat to their existence with the as-is operational models. One of the critical areas could be expediting clinical research from a traditional Sponsor-PI-Patient centric model to a virtualized/decentralized clinical trial framework. Technology service providers can leverage their traditional strengths in IoT technology, mobility, and AI/ML led big data platforms to ease clinical research participation, decentralize data collection methods, and unravel new intelligent data insights for faster decision making. Some of these players have strategic partnerships with niche and leading technology players to boost their product offerings with real-life COVID-19 related implementation scenarios. By leveraging this ecosystem, life sciences industry can make the resultant product ready to remotely deploy a HIPAA/GDPR compliant smart clinical trial platform in less than five days within a human quarantined environment, mitigating disease transmission risks to fellow participants. This is the need of the hour since resource and study mobilization in the COVID-19 era is nearly impossible.
HCL’s Virtualized/De-Centralized Clinical Trial Framework
HCL’s decentralized clinical trial framework (with COVID-19 workaround) includes medical-grade physiological devices and wearables, telemetry enabled intelligent IoT operations platform, eConsent, self-screening ePRO, and video conferencing tools as an integrated direct to patient platform. These can be set up remotely, enabling a paused trail to be up and running in less than five days.
HCL’s comprehensive Global Support Center has in-depth knowledge of healthcare systems, failure-proof governance, and communication mechanics for safety and remote patient monitoring. Our solution has adaptive patient-centered smart infectious research design with COVID-19 exposure assessment that can help companies ramp up patient screenings, remote patient monitoring, and minimize dropouts during the study phase.
Action to Mobilize
Here is a call to action for all research-oriented global companies. HCL’s rapid innovation team has the proficiency to guide healthcare systems to quickly design/redesign their operational strategies to tide over this crisis with minimal disruption to their operating environments. The all-encompassing platform-services reduces cross-supplier risk significantly with single point active governance. We have proven expertise in designing and implementing large scale setups as per global regulatory needs in a fraction of time and money required to run traditional large-scale studies.
There is no doubt that COVID 19 will change the operating models across industries on a global scale. More innovation can sustain and grow businesses in the new world order. More so for the life sciences and healthcare industry. Thinking differently and creating unique solutions to the current challenges are needs of the moment. The challenges are equally unique as well.