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PharmaVoice June Issue: A New Era of Clinical Trials

PharmaVoice June Issue: A New Era of Clinical Trials

Bioforum’s Insights on how Industry Responds to the COVID-19 Pandemic

Amir Malka, President & Co-Founder, BioForum the Data Masters

Q: How have your business operations changed?

Fundamentally, our business operations haven’t changed. They have been fortified with a renewed focus on value. Flexibility and being available whenever our customers and partners need us is at the core of our business model and everything we do. We take great pride in working hard and collaborating from each of our offices around the world and our homes when necessary. At the same time, the coronavirus pandemic has made it even more apparent that certain additional investments such as cloud infrastructure, for example, that enable our people to more seamlessly work remotely as they partner with clients on clinical trial-related activities, are not only necessary but invaluable.

With existing, up-to-date business continuity plans in place, we have been well prepared to deal with COVID-19’s impact on clinical trial operations. Our team immediately activated a complete and fully operational virtual environment to ensure continuous support for clients worldwide. We understand how mission critical the work we do is to enabling both ongoing and new clinical research. Ultimately, the coronavirus outbreak and resulting crisis forced us to focus on what really matters: doing our part to ensure vital new treatments get to patients as safely and quickly as possible.

Q: What do you believe will be the lasting impact on clinical operations/R&D?

We’re beginning to see significant R&D investments in vaccines, new drugs and diagnostics to help combat COVID-19. Collaborations within the industry and between industry and governments, academia and nonprofits are quickly evolving and showing promise. Regulators are also doing their part, streamlining their procedures and accelerating pathways to enable fast-track authorizations, while ensuring scientific rigor and the highest ethical standards remain paramount.

When it comes to tackling global public health threats such as pandemics, we’ll see a continued focus on and sense of urgency around such investments as well as collaboration, at all levels and across all geographies, including a new multifaceted approach that facilitates public-private partnerships. Across the clinical development ecosystem, all parties — from regulators to pharma, biotech, medical device, diagnostics and startup companies to academia and nonprofits to CROs and technology providers — will keep joining forces to prioritize public health. While the focus is currently on the coronavirus, this sense of true partnership will set a precedent for tackling and preventing future pandemics and developing next generation medicines that undress significant health risks, challenges and unmet needs worldwide, and hopefully continue to emphasize the need to put patients and, more broadly humanity, first.

Tanya du Plessis, Vice President, Data Strategies & Solutions, Bioforum the Data Masters

Q: How has the COVID-19 pandemic impacted clinical operations?

The COVID-19 pandemic has forced the industry to fast track decentralized, virtual clinical trials and hybrid data strategies. Quarantines implemented worldwide have delayed, temporarily halted, and, in some cases, altogether stopped vital medical research. And there’s a host of reasons why: patients participating and personnel involved in running studies need to self-isolate or drop out because of safety concerns or logistical challenges, trial resources have been redirected to other urgent healthcare needs, hospital systems are overwhelmed and many clinical trial sites are currently inaccessible.

Consequently, technologies and services that enable remote monitoring, telehealth and home healthcare are no longer just discussions, but must-have components of clinical studies.

Many companies have been looking to move in this direction for some time. However, it’s one thing to implement when it comes to a new study, but an even more complex and challenging undertaking to redirect a study with a traditional design and data collection model to a decentralized, virtual trial or hybrid model. The key for organizations that go down this path is to ensure they have all of the facts available to conduct proper risk management, whether they do this in house or bring in trusted partners to manage the process.

Q: How are you innovating in light of the global pandemic?

Even though regulatory authorities have provided helpful guidance, innovating during a global pandemic can be overwhelming. To support our customers as they navigate unchartered territory, we’re providing solutions that enable sponsors to more easily adhere to FDA and EMA guidelines for conducting clinical trials amid the COVID-19 pandemic. This includes support around risk evaluation for each specific trial, as well as rethinking data collection and handling strategies to protect data integrity. It also involves introducing and implementing new technologies for data collection and monitoring, and to mitigate existing and COVID-19-related risks. Additionally, we’re helping clients leverage these technologies to document the various implications the pandemic has on their trial operations, such as protocol deviations. As we assist clients in managing through the current crisis, we’re simultaneously working with them to incorporate decentralized, virtual trials and hybrid models into their future clinical development programs so that they are better prepared for future pandemics.

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