2 April 2020
Read the full statement from Halloran here.
Halloran has formed a company-wide task force to curate information on the impact to the life science industry due to the current COVID-19 environment. We are leveraging our most experienced subject matter experts, using our deep life science experience to assess and address in real time the issues and new challenges facing your programs. The biotech industry was born with the belief that we would change the world, and collectively, we have many times over. We recognize that we can arm your business and our industry with regulatory, clinical, quality, compliance and technology to keep potential lifesaving programs moving forward. Our insights below are shared freely to support programs designed to treat patients with just about every conceivable medical condition as well as patients with COVID-19.
Our firm is committed to positively impacting human health by bringing unwavering commitment and firm resolve to patients, your programs, and your corporate goals. We understand that creativity and expertise will be required to make this happen and ensure business continuity. Your Halloran colleagues are committed to bringing our expertise and creativity to keep your programs and company on track.
Clinical Trial Impact and Risk Mitigation
We’ve seen an immediate impact on clinical trials due to challenges coming from the COVID-19 travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into issues challenging corporate milestones, budgets, and data integrity – read the full list here.
Given the complex risk/benefit considerations associated with each specific clinical trial, there is no single solution to manage the risks facing clinical activities due to COVID-19. Each clinical trial is unique with respect to patient population, study drug mechanism of action, concomitant medications, and geographic needs. It is important to continue to engage the network and community to push forward with creative risk mitigation and issue resolution plans during this challenging time.
Impact to Regulatory Interactions, Inspections, and Audits
While we have not seen any significant delays in the approval of products to date, the impact of COVID-19 on global health authorities will continue to evolve. We expect a variety of potential delays in regulatory communication and meetings that will continue for months, if not years. Current travel restrictions and the remote working environment have brought several considerations (detailed further here).
Impact to Technology and Mitigations
With all of the above priorities coming our way, technology may be one area that you may consider not directly impacted by COVID-19. With many of our clients’ clinical and informatics platforms being cloud-based, most business continuity plans are not prepared for a near complete switch from in-office presence to remote users. For any plans that did, it was unlikely expected to occur nearly overnight as we are currently experiencing. As our clients transition to an entirely distributed (home-based) user environment, several points are worth highlighting.
We are actively monitoring the business and social impact that COVID-19 is having to our community in real-time. We recognize that most of the global workforce will be juggling a host of personal matters during regular working hours including childcare, distance learning curricula, and care for our extended families and communities. We also recognize that many of you are also implementing new processes and procedures to protect your employees from exposure to COVID-19 while requiring careful and clear communication in addition to the logistics of setting up remote working environments. What is clear is that all of us must plan for potential program delays and disruptions to our normal course of business for at least the next several weeks and perhaps months. While the Halloran team will be managing these same challenges at home, we are committed to being as flexible as possible to ensure that project plans stay their course with minimum delays and that we are keeping you informed of any issues and mitigations that may help as we navigate these uncertain times together.
Halloran will be hosting several virtual town hall meetings to engage our life science community to share experiences and solve for some of the common issues and challenges real-time. The first Virtual Town Hall: Impact of COVID-19 on Clinical Trials will be held on Friday, March 20, 2020 at 11:00am – Noon EST. Click here to learn more or RSVP. We are all in the business of getting lifesaving products to patients safely while doing what we can to prevent avoidable delays through creative solutions.
Halloran is available to help you develop and assess your own business continuity or response plans, including timely and targeted communications to your workforce, customers, and communities-at-large, so please reach out with any questions you may have.
Read the full statement – COVID-19 Impact and Halloran’s Response 3.18.20.