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In a heavily regulated industry where the stakes are high, changes to digital systems can be especially challenging.
By Annie B. Harris, Director, CTMS, Covance
When I joined Covance in a help-desk position in 1993, the technology world hadn't truly taken off yet. The Internet was in its infancy, MS-DOS was still the prevalent operating system, nobody worked from home. We actually used walkie-talkies to communicate throughout the building! Needless to say, technology transformation and migration were somewhat different then.
I moved from the help desk to programming one of the first out-of-the-box CTMS [clinical trial management system] programs, became the head of that team, and then moved on to head the team for our current CTMS. During that time, I also spent the better part of a decade as the liaison between business and IT, helping the business explain what they needed from IT to do their work. Today, as a director, I'm responsible for aligning information from multiple sources, linking other systems into our CTMS, and integrating and managing all the data going in and out of the system.
In the time I've been with Covance, we've merged with many other companies, so I've been involved in a lot of back-end efforts to merge their CTMS systems with ours. Data is data is data, but the data today is so much more complicated than it used to be, with more workflows that have to be brought into the new environment.
Pharma's response to digital disruption
The entire industry is realizing that it's on the precipice of having to do everything differently. A big part of that change is the expectation that everything will be done as quickly and conveniently as possible without sacrificing quality. In the case of Covance, which conducts clinical trials for pharmaceutical, biotech, and medical device companies, our employees and clients want to be able to access the CTMS via their laptop, their smartphone, their tablet, even their watch.
The industry is also conducting assessments of emerging technologies so that we might take advantage of what they can do. For example, blockchain technology will let us track all auditable data and see every bit of activity that takes place, but we have to make sure all our systems can handle it. We're also discussing how to improve patient recruitment and increase our focus on wearable sensors.
Clinical trials in particular require a carefully thought out technology road map. Trials can't be changed quickly just to keep up with changing technologies. Patient safety could be compromised. So the areas in which digital technologies currently have the greatest impact on how Covance performs clinical research include making the patient recruitment experience as seamless as possible and making it as easy as possible for patients to participate in clinical trials. Patient compliance is key in clinical trials, so a technology or multiple technologies that improve compliance rates – for example, gathering data using wearables instead of requiring the patient to visit a clinic – is a win-win.
Managing the evolution of CTMS
As technology changes, we’re expanding our CTMS both in terms of what we track and how we track it.
The ability to import data from and share data with other systems has completely changed the game. In the past, a clinical research assistant, working from a Word document, had to actually retype data about trial subjects from each clinic site into a tracking and approval system before filing a report. Today, we track the core CTMS data around each site visit. Every night, the CTMS automatically pulls in information from the electronic data system. We've also added e-signature process to support regulatory compliance. Once the report is approved, the system automatically sends it to an electronic trial master file system, which keeps the document management system intact without needing human intervention.
Another critical path task that technology has changed is site assessment. In the past, we had to visit every site at the beginning of a study, and every six to eight weeks thereafter. Now we have an option to apply a risk-based monitoring, or RBM, approach, with a system to evaluate how each specific clinic is performing and how it handles its subjects’ data. RBM studies are designed to enable the monitoring system to analyze site information to determine how often a particular site actually needs to be visited. The system then imports the data back into CTMS for documentation. RBM focuses monitoring where it will be most effective, safeguards patients and makes study management more efficient and cost effective.
The challenges of digital disruption
Documentation is everything in this industry. A regulator or pharma company can show up and request an audit at any time, so we have to document everything – with names and time stamps to show who requested something, who approved it, when it was done, and that it was verified. And we have to be able to provide that documentation on a moment's notice. Including that level of compliance in your systems makes it hard to implement new features quickly.
Transformation starts with understanding and sharing the need for change, with regression information to show how adding new features will affect current processes. You also need to discuss who will implement the changes and how they will affect current processes. You have to make sure the business has documented its processes correctly and that the IT team is prepared to support the new process being implemented.
Covance has established a change control review board that meets once a month. One representative from each department presents suggestions for enhancing the CTMS. The leaders then work with the IT team to determine which suggestions can be implemented and in what order until we have enough to release an upgrade. There are lots of factors that affect what we do and when, but we vet every single suggestion, and it helps people feel a sense of ownership around changes.
There is much work to do before new technologies can be optimized for research, because the industry is still assessing them. For clinical trials, we want to streamline processes as much as possible while keeping quality at the utmost highest. If we lose the trust of the pharma, biotech or medical device companies or patients, all is lost.
The pharmaceutical industry is not immune to consumer-driven pressures to make more data more accessible in more ways.
When compliance is business-critical, take the time to evaluate and implement new technologies instead of racing to be an early adopter.
Giving end users input into the changes they'd like to see in your systems helps to mitigate the fear of change and improve user satisfaction.