By: Mike Lange
The increasing adoption of cloud and Software-as-a-Service (SaaS) solutions in clinical research and development is having a profound and positive impact on clinical trials – increasing trial speed and efficiency, reducing cost, and enhancing patient safety. Integrated cloud platforms encompassing planning and trial conduct through submission and post-marketing are helping to break down the industry’s functional silos and unlocking even greater R&D innovation.
It is, however, still early days. Sponsor IT organizations and CROS are for the most part on board and are supporting the migration to cloud-based solutions. Yet many trial sponsors and manufacturers are struggling to adopt to the new environment.
While it’s relatively easy to define best practices and improved business processes enabled by cloud-based solutions – for example, through secure, anytime/anywhere access to data and collaborative environments – it’s much, much harder to operationalize them.
We hear a lot about transparency and better communication being keys to better sponsor and CRO relationships. Yet legacy practices take a long time to die. We still frequently encounter the emailing of massive spreadsheets between sponsors and CROs as the de facto “collaboration” process for planning and budgeting clinical trials – despite the inherent inefficiencies including added time and manual effort, security issues, and risk in this process.
Other reasons range from cultural – e.g., a highly risk-averse industry as a whole – as well as business interests – e.g., the tension between transactional and strategic sponsor/CRO relationships, and the drive to the lowest-cost model which may preclude a true strategic relationship. As just one example, a research study conducted by the Tufts Center for the Study of Drug Development – supported by an unrestricted grant from Oracle Health Sciences – found a persistent and prevalent use of transactional outsourcing relationships by sponsors.
So what is possible? How are leading sponsors and CROs taking advantage of clinical R&D cloud solutions today?
Planning for partnership trial excellence in the cloud starts at the very beginning, during the early portfolio trial planning and forecasting between sponsors and CROs. Replacing legacy spreadsheets as referred to previously, innovative sponsors and CROs are embracing a clinical cloud collaboration platform for long-range trial planning and study budgeting, as well as operational planning for the actual trial being run. Taking advantage of a secure, centralized repository for operational data accessible anytime/anywhere via the Internet, with clinical intelligence for therapeutic indications and clinical development data, these sponsors and CROs are reaping tremendous efficiencies in planning clinical trials by:
· Engaging earlier with collaborative scenario planning to ensure trial achievability, fair market value, and operational alignment to accelerate planning and minimize downstream changes
· Ensuring operational support of budget and resource planning by providing visibility to bidding process and results
· Aligning trial scenarios with study contracts, bids, and internal tasks and costs
· Simplifying the comparisons and benchmarking of bids
· Tracking and storing bids for historical and analytical purposes
One sponsor that implemented this platform and approach with its CRO partner was able to compress the contracting cycle-time from over three months to just two weeks. Just as importantly, CROs benefit directly as well: by building a more collaborative working relationship with their customers, maximizing margin contribution while still producing competitive bids, and responding quickly to customer requests for bids.
Faster, better, more affordable trials, with greater achievability and fewer downstream changes to add delays and cost. The cloud beckons.
About the Author: Mike Lange is Director, Product Strategy at Oracle Health Sciences, where he helps develop the next generation of eClinical software to enable the industry transform lives for the better by delivering safer and more effective therapies at dramatically faster speeds and lower costs.