The COVID-19 pandemic has led to numerous changes in the way we conduct clinical trials. Health authorities, sponsors, and CROs have rallied to keep clinical research moving forward as research teams, site personnel, and trial participants find themselves in various stages of lockdown around the globe. The common goal has continued to be maintaining patient safety and trial integrity.
The US FDA and the European Medicines Agency released guidelines for conducting trials during the current public health crisis. In part, the guidances speak to the move toward remote activities that impact patient safety during the pandemic. As WCG CenterWatch recently noted, “For trials that will continue, many sponsors are considering or actively seeking to change study protocols to allow for fewer onsite visits and more telemedicine or home visits, which can help reduce the risk of virus transmission.”1 In a recent survey of Mednet customers, more than two-thirds (68%) of respondents who made changes to their trials due to COVID-19 said they made changes to enable specific roles to perform tasks remotely.
Moving to Remote Operations
The constraints introduced during the pandemic have also led to fundamental changes to clinical data management processes. And with these changes come new opportunities and challenges. Approximately two-thirds (65%) of survey respondents believe the pandemic will have a lasting impact on the way trials are designed and conducted, with nearly all (95%) foresee enabling certain roles to perform tasks remotely.
Clinical trial teams are now assessing their own capabilities to address the challenges of remote work. As various regions begin to reopen at different rates, teams will require the flexibility to transition smoothly in and out of remote work. This trend will likely continue when offices reopen and individual company quarantine policies take effect.
Trial teams had to pivot quickly to keep clinical trials going during the pandemic. Most found that many activities and tasks relating to clinical trial data management and monitoring are well-suited for remote work. The quick transition to remote work in this state of constant change was a testament to their operational flexibility. The ability to maintain this flexibility is a measure of operational resilience.
Maintaining Operational Resilience
Operational resilience is directly linked to adaptability and the flexibility to act quickly when change is needed. McKinsey notes, “As the future of work becomes more remote and distributed, demand may shift to new capabilities and talent.”2 Flexible technologies play an essential role in enabling teams to communicate, collaborate, and quickly respond to emerging needs. Whether team members are forced to work remotely or choose to do so, the technology platform must accommodate continuing (and often rapid) change.
Clinical data management technologies must be robust enough to support intricate trial designs, yet flexible enough to enable team members around the globe to access and process data throughout the trial. Teams are now rethinking their standard operating procedures and leveraging technology in new ways. Remote workers require the same capabilities that onsite workers have. They expect the same user experience. They will seek out new tools to communicate and collaborate more effectively.
Flexible Technology Supporting Remote Work
At this moment in time, enabling solutions must pass the pandemic test. They must not only provide capabilities but also offer tools to support critical dialogues among remote personnel. They must afford robust capabilities that enable seasoned clinical professionals to design and conduct complex trials from their home office. They must allow deep collaboration with researcher team members seated at their kitchen tables. They must do all these things while still facilitating compliance.
The flexibility of clinical technologies will continue to hold the key to successful remote operations. As the pandemic subsides, many roles may remain remote; some positions may change or go away completely. In “Returning to Productivity post-COVID-19”, Brad Michel, Managing Director and Accenture’s Life Sciences Industry Lead for North America, notes, “Life sciences executives need to develop plans to determine what functions – in what order and at what percentages – to bring back onsite and which to leave remote, balancing the risk of COVID-19 infection with the need to deliver critical therapies and an economic restart.”3
The ease with which a team travels through this tumultuous process is directly related to the flexibility of their chosen clinical technology. Mednet is committed to developing flexible solutions designed to adapt to evolving requirements and new demands, standing the test of time.