It’s 2025 and it appears that turbulence is now the new normal in clinical trials. From public health emergencies to natural disasters and geopolitical crises, clinical trial teams have dealt with ongoing challenges over the past five years, impacting participant recruitment, disrupting supply chains, and even jeopardizing participant treatment.
As a result, trial teams have identified important learnings. Several case studies from one of the industry’s leading providers of Interactive Response Technology (IRT) demonstrate how its technology, teamwork, and internal processes are now more resilient than ever.
The start of a storm: Brexit and the great depot switch
“We knew we had around four years to deal with [the impact of Brexit], but we also knew it was going to be a challenge,” recalls Andrew Redfern, Account Manager at Perceptive eClinical, a longstanding clinical trial solutions provider which has supported its clients through several supply chain and operational hurdles over the years.
Such challenges have only strengthened the team’s internal risk mitigation and study management processes and even shaped new product innovation, with a key example arising when the United Kingdom (UK) voted to leave the European Union (EU) in 2016, affecting more than 160 studies that Perceptive was working on in which a central UK depot was supplying sites in the EU.
According to Redfern, a series of collaborative meetings were immediately held amongst the company’s subject matter expert groups and with clients. The crux of the challenge was identified: Brexit was going to come into force on a deadline of 31 January 2020, meaning the depot switch had to take place on or before that day.
“Working with one of our established accounts, we designed what we called a depot switch transaction for these studies,” explains Redfern. “When the client was ready to switch from their UK central depot – meaning they’d done all the paperwork and had physically moved their kits across to the EU – they themselves could go into a particular study on the IRT and press a switch, and that would then immediately switch all our relevant supply chain, depot & site supply strategies and integrations from the UK depot to the new one.
“We were able to deliver this depot switch transaction successfully within the timeline that the sponsor needed, and the EU sites and study participants saw no impact whatsoever,” he states.
This on-the-fly innovation has now developed into a new module for the client which can be used when changing between second-choice and first-choice depots as a trial evolves. Moreover, in a world that is currently filled with political and economic instability, and with climate-related hazards on the rise, this new module is expected to become instrumental for switching country participation “on and off” in response to confirmed or potential supply disruptions around the world.
Development of this specific country and depot management capability was one of a range of solutions that the Perceptive teams deployed to address this single challenge, with solutions suited to different study team needs.
COVID-19 and other crises
Whilst the depot-switching solution was being developed, ongoing clinical trials faced a new global challenge. With the COVID-19 pandemic ramping up in March 2020, the world was going into lockdown, and the outlook for clinical trials was uncertain.
At Perceptive, more than 700 ongoing studies were impacted by the pandemic. Perceptive’s study teams proactively compiled and sent out large quantities of trial data to sponsors to help them understand the impacts on their sites and participants. Meanwhile, new approaches were tested to keep trials moving while reducing the need for participants to come to sites. Participants were front-loaded with medication where appropriate, while a configurable module for direct-to-participant shipments was introduced in many studies. Amid all this, there was also a need for rapid trial start-ups for COVID-19 therapies and vaccines, putting Perceptive’s teamwork and delivery speed to the test.
“Around the time of the COVID outbreak, we were approached with several very fast-paced trials in which we used our global staff base and their different timezones to their best advantage to push things very quickly,” says Matt Henson, Account Manager. “COVID may have been a once-in-a-lifetime kind of event, but there are principles that we’ve taken from it and ways that we learned to collaborate with our teams more closely as a result.”
Since then, a range of other issues have arisen, including ongoing wars in Ukraine and Gaza, earthquakes in Turkey and Syria, and several widespread cybersecurity incidents. For Perceptive eClinical, the goal is always to stay one step ahead of the crisis, suggesting solutions before clients have even raised concerns to minimise and prevent any potential impact on participants and sites.
Managing cybersecurity threats in clinical trials
For example, in December 2021, a critical vulnerability was found in a tool commonly used across a wide range of people, sectors and organizations worldwide; it allowed bad actors to easily exploit a common building block of modern logging software and take over computer servers. Perceptive took immediate action to prepare their customers by performing a comprehensive risk review of all studies and sharing a full communication plan.
Cyber threat actors have continued to target healthcare organizations due to the value of the data they hold. A ransomware attack in June 2024 on a pathology laboratory had a direct impact on patient care, causing National Health Services in the UK to cancel patient appointments and disrupt blood test results. Again, the Perceptive team pre-empted study team needs by creating a specific ransomware plan to best manage the risks that some customers faced.
A continuously improving business continuity plan
A robust and continuously improving business continuity plan (BCP) has now evolved. During difficult times such as Russia’s invasion of Ukraine, this plan is communicated with all relevant parties as a selection of actions they can take to minimize trial disruption.
“We presented various solutions and options based on different scenarios and sent that out [to clients] in advance as an agreed plan,” explains Sam Carrington, Director, Project and Program Management. “For example, if you’ve got a participant that can’t attend their visit, do this, or if you’ve got a participant that needs to move to a different site, then do this.” Plans would detail all possibilities with associated actions needed.
“What’s good about [the BCP] is that it has now become a standard that we use,” adds James Hayday, Director, Service Operations, Perceptive’s global customer help desk team. “A lot of the solutions are applicable in the case of Brexit, in a war crisis, or in a natural disaster. We obviously tailor them towards the situation, but we’ve developed a really strong foundation that we can work from.”
As new lessons are learned, these are fed into the BCP and in some cases, even the IRT itself. “We have frequent lessons learned meetings,” says Redfern. “If clients have new challenges, we want to understand them and feed them back into the innovation. For example, how can we allow the end-users of the IRT to better make changes themselves with immediate effect, or how can we allow them to see the risk coming ahead of time and be able to do something proactive about it?”
Overall, several recent challenges have emphasized the vulnerability of clinical trial supply networks across the past five years, and the importance of greater proactivity and collaboration between stakeholders cannot now be understated. As the industry moves forward, finding the right partner and software to manage complex participant randomization and trial supply logistics will be essential for safeguarding the continuity of studies and treatment of participants both day-to-day and in the next major crisis.
Perceptive eClinical has supported 4,700 clinical trials over its 30 years of experience, leading to strong processes for identifying risk, communicating with clients, and taking preventative action. Exceptional collaboration, communication and customer care are core to its study management approach, and a 24/7/365 in-house help desk with specialized teams supporting 170 different languages mean that help is always within reach.
