2020 brought digital disruption to the center of all businesses, in all industries. In Life Sciences, organizations faced unparalleled challenges as they worked remotely to bring life saving therapies to market, monitor clinical trials remotely and balance regulatory challenges on a global scale.
As restrictions start to lift and healthcare facilities open up patient access for clinical trials most Life Sciences find themselves in a situation where clinicians still work remotely and require remote access to clinical study sites. Site access often requires access to several paper documents and Investigator Site Files (ISFs) as well as patient Informed Consent Forms (ICF). And, with limited physical access to these sites, the need for digitization has never been more clear.
At our first ever BoxWorks Digital, we had conversations with clinical leaders at PRA Health Sciences to discuss how they're evolving on their digital journey throughout a pandemic, key challenges along the way, and how they're solving them by automating legacy processes. Here are some key takeaways:
Always focus on patient processes
Clinical Research Organizations (CROs) like PRA Health Sciences are dedicated to bridging the gap between legacy processes and the future of healthcare connectivity by focusing on patient centric processes. For example, the informed consent process is a critical end point in the clinical research process in which the sponsors' goals interface directly with a target patient. As such, there is enormous amount of scrutiny in place by all party's involved including regulators overseeing the development, management and tracking of all Informed Consent Forms (ICFs).
At PRA Health Sciences, about 700 employees are involved in ICF review process with over 31,000 ICFs processed in 2019 alone. Nikki Bennet, Sr. Director Clinical Delivery, PRA Health Sciences candidly states, "Informed consent is the central tenet of research ethics involving human beings, and the informed consent document is a crucial part in the running of a clinical trial."
Keep patients at the center of trials by optimizing informed consent processes across all parties with cloud solutions like Box. With Box, centralize your ICFs in one platform easily sharing files in real-time with third parties, sponsors, and internal teams.
Reduce the complexities of key processes
In addition to the sheer volume of ICFs generated during clinical trials, paper-based and legacy processes create content silos with no audit trails, making it hard to track reviews and approvals. Plus, when ICF documents are digitized added complexity of language translations is added to ensure patient understanding. Like PRA Health Sciences, reduce manual complexities and accelerate informed content processes across Sponsors, CROs, Healthcare authorities as well as patient with Box. Here's how:
- Accelerate key process across sponsors, CROs, and third parties with automations and workflows with Box Relay
- Centralize all ICFs on the same platform, ensuring consistency across parties collaborating on the same set of documents
- Reduce security risks and maintain control of the ICF process with audit trails, access policies, and document security
- Plus, securely share site documents with trial management teams with Box File Request. CRO's like PRA empower trial managers to quickly spin micro-sites to receive content and related metadata without the barrier of onboarding site personnel with this new Box feature
Look to the future with automated processes
As Life Sciences businesses move further along their digital transformation journey, moving legacy processes to the cloud has never been more relevant. Claudia Charlier, Product Director Business Performance, PRA Health Sciences said it best, "Research has shown that by the end of 2021, more than half of the CROs expect to be fully connected digitally with their sites "
Life sciences are in the early stages of automation, turning once paper-based workflows into automated reviews and approvals. Once sponsors and CROs start to realize these accelerators in employee overhead and time to market, it will give them a competitive advantage and pave the way more intelligent automation solutions. With more advanced solutions, where trigger point automation and signal detection capabilities are baked into the offering, organizations like PRA can extend the benefits of automation beyond clinical operations to smart pharmacovigilance as well.
As IT leaders in Life Sciences strategize for 2021 and beyond, it's important to utilize this as an opportunity to rethink the normal. Pipeline commitments and personnel habits have a tendency to fall back to the status quo, but forward thinking leaders today will gear up to harness the power of cloud platforms like Box to realize benefits that will redefine how they work in the future.
Watch the full session here.
- Simplifying GxP compliance in the cloud
- Powering up clinical collaboration