It’s a new age – one of collaboration, not competition. Of co-development, remote working, and remote clinical trials. And, for Life Sciences companies slowly getting back to “business as usual”, success will come from rethinking the established models of the past and embracing the new. Covid-19’s impact upon the Life Sciences sector was fast, disruptive, and – in many instances – debilitating. As early as April, the industry began to see a dramatic decline in R&D lab capacity. With the enforced halting of many clinical trials, the pipeline pressures also increased as the need to bring drugs and therapies to market faster grew.
While many other industries have suffered setbacks, Life Sciences has faced the dual challenge of weathering this storm while also leading the charge on a long-term response to the virus. With many in the Biopharma world shifting focus from previous priorities to COVID-19 vaccine research, testing and treatments, R&D teams have been under greater pressure than ever to deliver. Indeed, we have also seen traditional competitors working together to accelerate development and share costs.
As a result, Life Sciences organizations have not only needed to find new ways to keep research programs up and running at a time when labs have been shuttered and teams separated, they have had to find new and effective ways of managing these cross-industry relationships too. Naturally, the focus for many during this time turned to collaborative digital technologies, innovative tools that could facilitate the safe and consistent transfer of critical data. From remote working to remote trial monitoring, Life Sciences companies have been driven to find digital ways to collaborate, share, and communicate over the past year.
For some, this transition has been tough. Challenged by the speed of the crisis, many were left racing to implement the technologies and techniques needed in order to maintain business operations and employee productivity. For others, pre-pandemic adoption of those transformative approaches has delivered an instant return on investment and the flexible framework required to adapt at speed.
New realities, of course, bring new challenges. As R&D teams begin to work remotely more regularly, IT directors will increasingly be tasked with creating (and securing) these seamlessly collaborative user experiences. Stepping up to that demand will mean rethinking traditional ways of working, and taking advantage of Cloud Content Management by Box.
Box prioritizes secure digital collaboration across internal teams, vendors, suppliers, and partners – so everyone can work efficiently from anywhere, on any device. It also automates review and approval processes to accelerate workflows between teams scattered across multiple geographies. Moreover, Box meets – and in many cases exceeds – the standards of speed, quality, and security that today’s Life Sciences organizations and regulatory bodies demand.
Crucially, the opportunities here go much further than just the day-to-day. Implemented correctly, CCM has the capability to transform clinical and regulatory operations, too. Let’s look at just two examples of how Box customers have used CCM to keep moving forward during the pandemic.
Remote clinical trial monitoring
The speed with which new therapies and devices make it to market is bound closely to the success and efficiency of clinical trials. With in-person clinical site visits growing increasingly difficult to conduct, CCM offers the ability to access, verify and share source and patient documentation without the need for physical intervention. It can:
- Speed up the verification of source documents and patient records.
- Provide greater control, reduce errors, and enable rapid access to regulated site documents
- Boost productivity while also ensuring GxP compliance and audit trails of actions
- Reduce costs by allowing legacy infrastructure and paper-based systems to be retired.
Health Care authorities like the FDA and EMA still need to conduct routine inspections and audits, but are unable to do so in person. CCM can support in a number of ways to:
- Enable Life Sciences teams to access, share, and collaborate on essential audit materials including Standard Operating Procedures, policies, and work instructions.
- Build rules-based workflows that enable automating review processes with selected parties for a pre-determined length of time.
- Create centralized repositories for key documentation ordered by topic, facilitating the timely retrieval against an inspection checklist.
- Gather access stats and maintain chain of custody through an audit trail.
- Help sponsors and CROs to spin up secure workspaces to conduct inspections virtually.
Over the course of this blog series, we’ll be taking an in-depth look at how CCM can help forward-thinking Life Sciences organizations turn unavoidable changes into unforeseen opportunities. From the examples above to consent, compliance, and more, join us as we continue to explore the transformational potential of cloud-based collaboration in this vital sector.