IN PARTNERSHIP
can minimise the time staff members spend interacting with study participants. The informed consent form (ICF) may be explained over video and staff members should stay 6ft away from participants when answering any questions.
Collaboration and assessment In this chaotic health climate, sponsors and CROs must work together and optimise their communication to ensure a successful collaboration. Diligent monitoring of the apparent risks is critical, as is quickly developing contingency plans to respond to changes in the environment. Sponsors and CROs must discuss changes in health data and government regulations, and regularly update study conduct policies. During this collaborative effort, they will need to balance participant safety and trial integrity with funding and revenue concerns. On a case-by-case basis, CROs should engage sponsors in discussions to determine the best way to maintain participant and staff safety while achieving the objectives of each study. They should emphasise direct and clear communication with their sponsors at all times. To this end, it’s important that CROs regularly collaborate with their sponsors on potential changes in Covid-19 precautions, including, but not limited to, changes in study scope, timelines and cohort assignments. The companies that CROs choose as partners
can have a profound impact on the success of their operations, especially during this critical time, so it’s important that CROs thoroughly evaluate their candidates. CROs should carefully assess laboratories and shipping vendors for quality and communicate clearly with these vendors to streamline operations. When it comes to lab resources, CROs must align their knowledge of testing and validation with clinical operations. For example, all laboratory and shipping
vendors used by QPS are required to have business continuity plans (BCPs) in place. The company works with these vendors to qualify its BCPs and determine if there are any gaps in the QPS BCP, and incorporate any relevant updates as needed. As it is especially concerned about sample shipments for bioanalysis, it only uses the highest-qualified vendors for these shipments. After carefully considering reliability and cost, each study site selects the most appropriate vendor for study sample shipment.
Regulations and flexibility Public health authorities play a critical role in protecting people from the threats posed by infectious diseases like Covid-19. CROs must follow guidelines prepared by all applicable public health authorities, including WHO, FDA, CDC, ECDC and EMA. To ensure the legality of operations and the safety of study participants, adherence to local regulations for each site should always be the highest priority. CROs should assess policy considerations that will impact their clinical programmes in the longer term, and consult their local governances and regulatory agencies when necessary. In addition, their facilities should be fully prepared to make the necessary changes to clinical trial sites to maintain compliance with frequently evolving local guidelines and regulations. Companies must remain agile and flexible so that they can implement new strategies to keep projects on track during this challenging time. To avoid the sudden devastation that has impacted so many businesses these past few months, CROs should speedily update the strategies and processes used before the Covid-19 pandemic, forming new tactics that are more suitable to this new environment. Wherever possible, CROs should offer multiple components of the drug development process to boost flexibility and diversification. By maintaining its relentless focus on customer-
driven, custom-built solutions, QPS is determined to remain open for business and support its clients throughout the pandemic. It encourages its fellow CROs to do the same.
Build resilience in the face of uncertainty As Covid-19 cases continue to escalate around the world, it is impossible to know how this global health crisis will affect clinical drug development. Nevertheless, the five core attributes of SCARF – safety, assessment, regulations, collaboration, and flexibility – can help CROs face the present uncertainty with strength and resilience. Although there is not a one-size-fits-all solution for the near and longer-term challenges introduced by Covid- 19, the attributes QPS has described may help CROs weather this crisis. The magnitude and nature of the issues introduced by the virus will vary substantially as the pandemic evolves, but resilient companies that are willing and prepared to rapidly adapt will likely have the strongest chances of success. ●
www.qps.com Outsourcing in Clinical Trials Handbook | 15
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