As a global clinical research organisation (CRO), Worldwide Clinical Trials provides full-service drug development services to the pharmaceutical and biotechnology industries.
We recently spoke to Chris Standley and Lisa Cross from Worldwide to find out how the organisation is helping to transform patient lives and is using electronic signatures to improve its processes.
Q: To start, can you tell us a bit about Worldwide Clinical Trials and your roles within the company?
Chris: Worldwide Clinical Trials is a full-service CRO. We’ve been in operation now for around nine years, during which time, we’ve grown considerably. We have in the region of 1,400 employees across the world and offer everything from early phase, first-in-man studies, through to post-marketing observational studies.
I’m the VP of trial technologies. I have ultimate responsibility for all of the e-clinical systems we use. Essentially, that’s all the systems that relate directly to studies, as opposed to the traditional enterprise systems. I have colleagues who look after the systems that every organisation has — the HR systems, the finance systems and so on. But my focus is those systems that directly relate to the patients.
Lisa: I sit within Chris’s group, as a trial technologies project manager. So, I manage any of the projects around adopting e-clinical solutions. I led the implementation of DocuSign across the organisation.
Q: What were you looking to resolve when you began looking at eSignatures?
Chris: The whole business of running a clinical study is heavily regulated. Success is dependent on collecting the appropriate documentation that proves the veracity of the data and the integrity of the results. Consequently, there’s a big onus on document approvals and reviews. There’s a lot of formal industry-specific documentation that needs to be managed.
Up to this point, we’d been doing that with paper-based systems. We’re a large multi-national organisation that was heavily reliant on paper, which resulted in a lot of documents being couriered all over the world. The main problems with that are lack of tracking, difficulty in pinning down the status of the documents, and it introduced delays. Any delay that impacts the study delays the drugs getting to market and improving the quality of life for our patients. It also increases the costs of running the study in the first place for our clients.
We were looking to move out of that antiquated approach; to bring modern technology to bare; to dramatically improve the efficiency of our operations, and speed up the time in which we can deliver studies and support the delivery of drugs to market.
Q: Do you know how long this process was taking previously?
Lisa: When we initially adopted DocuSign, we piloted it on some of the non-clinical groups, such as HR, legal and finance.
For the HR use case, the new-starter packs went from a seven-day turnaround and a 30% Not in Good Order (NIGO) rate to less than one day and a less than 5% NIGO.
In legal, there are certain contracts that need to go to all corners of the globe. So, before DocuSign, some contracts were taking months to be signed and executed. The turnaround time has now been reduced from months to about four days. And, again, with a significant reduction in the NIGO rate.
As we adopt more use cases, we’re seeing more benefits. We’ve started with regulatory documentation, initially with the sign-off of our standard operating procedures with our QA group. It has reduced the NIGO rate from 20% to 2.5% so far.
Q: What do those results mean for your business and the people you serve?
Chris: We have many “customers”. Some of our customers are the staff who work at Worldwide Clinical Trials. From their point of view, it makes life a lot easier. They can know exactly what the status of a document is. They spend less time chasing down signatures, which makes their lives easier and more efficient.
Our other customers are the pharmaceutical and biotechnology companies, the sponsors – those who engage with us to run clinical studies. Fundamentally, they will see a more efficient study. Studies range in size from small numbers of patients to large studies with thousands of patients over multiple sites, over multiple years.
Due to economies of scale, anything you can do to speed up getting a site up and running, for example, has an enormous impact on the duration of the overall study. If we speed up the time it takes to get from identifying a new potential site, to getting them contracted, on-boarded and up and running with drug and patients, then that has a significant impact on the duration of the study, which means it’s more efficient as the study doesn’t have to run as long.
And finally, our other customers are the patients. From a patient’s point of view, while they may not interact directly with DocuSign, anything we can do to speed up the completion of those studies and the delivery of the drugs to market has the potential to benefit patients who need access to the latest and best treatments and therapies.
Q: Is there a study that Worldwide Clinical Trials specialises in or do you work across the board?
Chris: We cover all types of studies because we support all the different phases of a clinical study. Everything from an early phase unit that does first-in-man healthy volunteer kind of work, all the way through to a dedicated group who focuses on post-marketing and late-phase studies, where the drugs have been licensed and released and you’re analysing how they perform in the real world, post-approval.
We are specifically focused on a few targeted therapeutic areas – studies within the Central Nervous System (CNS), cardiovascular disease, and immune-mediated inflammatory disorders, and rare disease across these areas. As an organisation, our philosophy is to use our scientific expertise in these targeted areas to support clinical research in innovative new ways, to help bring drugs to market.
Q: How did you first hear about DocuSign?
Chris: A number of people in the organisation had come across DocuSign in other aspects of their lives. That may have been for relatively mundane things, such as signing a contract to rent a house, where they’ve come across eSignatures as an approach. That immediately makes you wonder what the potential is within your particular industry.
We also partner with a number of key strategic technology vendors who support us with their systems to help us deliver clinical studies. One of those vendors, who provides document management systems, recently partnered with DocuSign, which peaked our interest.
Q: As you started with a pilot of DocuSign, it sounds like you’ve taken the land and expand approach to deploying eSignatures?
Chris: Yes, very much so. We wanted to run a pilot to demonstrate the ease of getting the DocuSign system up and running, and the immediate value it would have to end users. We knew we could immediately run a pilot in a part of the business that wasn’t directly impacted by regulatory record-keeping and processes.
Once people started interacting with DocuSign and using it in a group like HR, word quickly spread that it was saving them time and they were really pleased with it. We found it was a great way to build up enthusiasm internally, which we’re now harnessing as we roll the product out through the wider organisation. We’re picking off the use cases that give us the biggest return and working our way out from there.
Q: What aspects of DocuSign made it a good fit to solve your issues?
Chris: The regulatory angle is important. As a company within a heavily regulated industry, we must have an eye on what would be acceptable to the regulators and to our clients at all times. DocuSign demonstrated that it can meet industry regulatory requirements.
One of the main appeals of the solution was that it was 21 CFR Part 11 compliant. That immediately gives you credibility when it comes to dealing with the quality assurance folks, both internally and externally. Being able to demonstrate that the electronic signatures are embedded into the document and that there’s an audit trail is key to meeting industry regulations. There are other electronic signature solutions out there that may not deliver the same level of assurance.
Q: Have you had any feedback on the approach from your users, whether it be patients, clients, or staff?
Lisa: As people are being sent documents in other departments, there’s an instant demand for it to be released elsewhere. As soon as we deployed it to the non-clinical side, it triggered demand for everyone to start using it. The feedback we get when people use it is, “Why didn’t we do this ten years ago?” That is pretty much what I hear most of the time.
Q: In terms of the deployment, how was that in getting it up and running and working with the DocuSign team?
Lisa: Overall, it went smoothly. Anything that I needed to do around the 21 CRF Part 11 compliance, which is very important in terms of our deployment, was all there and I had help from DocuSign’s professional services team. So, it was very straightforward for me from a project management perspective.
Q: Do you have any advice for other organisations who are thinking of utilising electronic signatures?
Lisa: My main advice is to take small steps. Our HR group was ideal because they’re generally great with giving feedback, and also because everyone interacts with HR at some point. They’re a small group that has a large impact across the entire organisation. Having that small use case helped us focus on what we needed to consider as we expand it out to other groups.
Chris: The other thing we found useful was attending the DocuSign conference last year in London. At that point, we were planning our pilot and implementation, and mulling over the best way to approach this. It was helpful to attend and listen to approaches that other organisations had taken. We could learn from their experiences and what worked for them, what hadn’t worked for them, and how they were able to focus on particular use cases that had a disproportionately large return on investment.
My advice would be this: rather than trying to roll it out for every use case in the organisation just as a point of principle, think about where you are going to get the best value, in the shortest amount of time. Pick one of those areas and implement it. You can then demonstrate that either by virtue of the efficiencies of collecting the signatures or just the efficiencies of scale, you can gain great benefits from it. Then build out from there.
Q: And, to finish, what three words come to mind when you think of DocuSign?
Chris: Fast, simple and easy.
Thanks for your time, Chris and Lisa!
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