Worldwide Clinical Trials (Worldwide) is a global, mid-sized, award-winning Contract Research Organisation (CRO). The Worldwide team helps sponsors make the vital leap from medical discovery to commercialisation of a market-ready drug. For the team that works in its Nottingham hub, there’s an immense satisfaction that comes with conducting clinical trials of a much-needed medication and putting it into the hands of those who depend on it for their quality of life.
Needless to say, it’s a process reliant on careful record-keeping as evidence of regulatory compliance and quality control. There’s no room for error when it comes to medicine, and patient data.
Process friction delays the delivery of drugs to market
An enemy of the clinical trial process is friction. When things don’t go smoothly, or there are delays, real lives are impacted. Which is why Worldwide makes it its business to remove friction wherever possible and put life-prolonging therapies into people’s hands faster. Paperwork was an obvious candidate for improvement.
“We took a look at our system of agreement and recognised it typically contained a number of manual hand-offs. There were points at which we were stepping outside of our systems and printing off data. That data sometimes travelled to our stakeholders by courier, i.e. outside of our control,” says Chris Standley, Vice President, Vendor Governance.
The team found itself dividing its time between new trials and a seemingly-endless paperchase relating to existing ones. Dissatisfied with introducing this level of risk into a meticulously-run operation, Worldwide sought a way to keep control of its documentation at every step. The DocuSign Agreement Cloud promised just that.
Digit-ising clinical trial documentation
Introducing DocuSign’s eSignature solution into the signing and routing of clinical trial documentation yielded benefits above and beyond anticipation. Tracking critical forms became instantly possible. Costs immediately fell as couriers were no longer a part of the workflow, and Worldwide was able to reduce its formerly-heavy reliance on off-site storage space. Standley describes it as a breath of fresh air.
However, it was accuracy gains that most impressed the team in every business area where DocuSign has been introduced, including Legal, and HR where it all started. Importantly teams saw their “not in good order” (NIGO) rates reduce significantly, this was particularly critical for the Quality Assurance Group who oversee Worldwide’s regulatory compliance.
“We piloted the replacement of paper with eSignatures within HR’s candidate onboarding processes,” explains Standley.
“We purposely selected a business unit that managed a great deal of paperwork but that wasn’t heavily governed by regulatory controls.”
The pilot saw the turnaround for HR onboarding paperwork fall from seven days to a single day through eliminating manual steps, including transcribing data back into the HR system. The results were so gratifying that the DocuSign project took on a life of its own, with other business units vying for the opportunity to be next.
Key advantages of cloud-based agreements to life sciences organisations
In considering the key advantages that cloud-based agreements deliver to its organisation, which equally apply to any organisation working in high-impact areas within a highly-regulated space, Worldwide list the following:
- Speed to market – automating agreement workflow and using eSignature technology for routing forms results in the ability to launch new medicines and devices faster.
- Trial governance – from streamlining the recruitment of participants to assuring data is both accurate and accessible, moving documentation into the cloud assures the quality of trials.
- Regulatory compliance – CROs come under scrutiny to demonstrate that they have followed regulatory requirements to the letter. Using approved documentation templates, routing them automatically for signature, tracking them at every step, and finally storing them in the cloud where they are easily accessible for review, helps ensure strong compliance.
It’s only the beginning of an ongoing journey for Worldwide, now looking down the line to new opportunities to use DocuSign’s APIs to integrate automation and efficiency into an increasing number of business processes.