An Efficient Approach to Managing Complex Insurance Programs

Global biopharmaceutical giant Bristol Myers Squibb is focused on developing innovative medicines that address the unmet needs of patients with serious diseases. Clinical trials are key to the company’s research and development (R&D) process. Teams internal to Bristol Myers Squibb conduct some of these studies, while external clinical research organizations (CROs) handle others. Either way, insurance is a prerequisite before any clinical trial can get under way.

“Clinical trial insurance protects participants, covering expenses in the event that a patient sustains injuries during the trial,” explains Henry Huseby, director, corporate insurances. “The unique challenge for a global pharma company is that every country requires you to have clinical trial insurance, but no two countries are the same. The insurance you buy in Romania is completely different from what you buy in Australia.”

Bristol Myers Squibb must submit documentation to each nation’s ethics committee, Ministry of Health, or other agency, as dictated by local law. In addition to proof of insurance, these submissions include details such as the title of the study, number of patients, purpose of the trial, and testing sites (in some jurisdictions). Some countries require all this information to be submitted in the local language.

Huseby’s corporate insurance team manages all of Bristol Myers Squibb’s insurance programs—including property insurance, directors and officers (D&O), cybersecurity insurance, workers comp, etc.—with the exception only of the employee health insurance plan. A couple of years ago, the clinical trial insurance program was taking an exorbitant proportion of the team’s time.

As middlemen in the process of securing insurance, the team would receive protocols from a clinical trial’s internal study lead or external CRO, then put together the necessary information for prospective insurers in each geographic area involved in the study. “One protocol might apply to a trial across a dozen countries, but every one of those countries would require a separate insurance certificate,” Huseby explains. Plus, depending on the length of the clinical trial, the insurance policy might need to be renewed regularly—a two-year interval is typical for insurance renewals.

Another challenge for the team was that insurance and regulatory submissions needed updating anytime information changed. “There are times when, for example, the study’s title might change a little bit, or the length of the study might be extended; during Covid, quite a few studies were extended,” Huseby recounts. “A single study might experience multiple changes in a given year, and each change requires updates to insurance and compliance documentation in every country.

“We are tracking around 2,000 discrete insurance certificates and policies, within 70 or so countries, at any time,” he continues. “Making sure everything is up to date requires a huge amount of administrative work.”

Previously, the corporate insurance team managed all this documentation manually, using Microsoft Word, Excel, and email. If the protocols submitted by the R&D group contained errors or lacked necessary information, the corporate insurance team would have to reach out for clarification.

“The Word and Excel files were generic,” explains Meghan Senesi, senior manager, corporate insurances, for Bristol Myers Squibb, “so when individuals were filling them out, they might not provide everything a specific country required. Collecting all the right details for a given country might take 10 emails back and forth. That could slow down the insurance submissions process, which could potentially delay the clinical trial, meaning medical advances might take longer to get to market.”

Worse, Huseby adds, “even during the pandemic, some of these countries still required wet signatures on forms. So our broker and insurer would FedEx me documents, I would sign them, and I would FedEx them back. They would stamp them and send them on to the study manager. So providing documentation could literally take weeks.”

The manual process was inefficient and unsustainable. “Clinical trial insurance is only part of our responsibility, but it was taking 90 percent of our time,” he says. “After a merger in 2019, our clinical trial volume increased dramatically. Meghan and I would work until 10 p.m. or 11 p.m. addressing emails, and by the time we woke up in the morning, we would have another 200 emails related to clinical trial insurance.” To reduce the burden on the team and ensure that they were not slowing down studies, the corporate insurance team launched an initiative to revamp the management and submission of clinical trial information.

“At the time, Bristol Myers Squibb was looking at what we called ‘the art of the possible,’” Huseby says. “We knew we needed a change, and we wanted to explore what was possible. I approached our treasurer and requested funding to pursue improvements to our processes around clinical trial insurance.”

The corporate insurance team delineated the clinical trial documentation requirements in every country, mocked up a separate form tailored to each nation, and vetted these forms with their insurers and insurance broker to make sure they hadn’t missed any requirements. Then they engaged PwC to develop a prototype of an online database tool for storing clinical trial data and automating management of that information. The corporate insurance team showed the prototype to their insurance brokers, as well as internal study leads and IT staff, and requested feedback.

“There was a whole process of working with the study leads and IT to make sure that submitting a request is seamless, and that the form is collecting all the required information and documents for each country,” Senesi says. “We ran a few pilot projects with small teams in specific locations until we were confident that we had not missed anything.”

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Today, when an R&D group needs to obtain insurance and submit an upcoming clinical trial for regulatory approval, they go into the new online tool and select the appropriate country and protocol. “We’ve designed the tool so that when they specify the country, the form populates with questions specific to that insurance and regulatory environment,” Senesi says. “The user can also upload any required documentation. It’s nice because the information arrives in a format that we can vet right in the tool, then send on to the insurer.”

As soon as the insurer approves the request, Bristol Myers Squibb’s insurance broker emails a copy of the insurance certificate to the clinical trial study lead and updates the status of the request within the Bristol Myers Squibb tool. If something subsequently changes with the study, the person who originally submitted the insurance request can make the requisite adjustment in the online form, rather than starting from scratch on a paper version. Thus, the process of requesting an insurance amendment has shrunk from hours to less than a minute.

The new tool has also greatly improved visibility—for both the corporate insurance team and the R&D groups—into the approval status for each request. “This tool provides an audit trail for submissions, so we have complete visibility into who submitted information on the R&D side and whether the insurance has been approved,” Senesi says. “If there are ever any questions, the answers are easy to find, in one place. For instance, just yesterday in a meeting, someone had a question about clinical trial insurance in a particular country, and I was able to pull up the dashboard and instantly provide an answer. As a matter of fact, this tool probably contains the most comprehensive list of clinical trials in the entire company.”

In addition, she adds, “I can investigate and identify issues as soon as they arise. When the process was all Excel and emails, it was very difficult to proactively identify problems.”

“The more quickly we can get life-saving drugs to patients, the better,” Huseby says. “This tool puts us in a better position to make sure clinical trials can start on time. There’s much less back and forth on each request—and by streamlining the submission process, the tool enables our team, as well as the requestors, to use our time more wisely.”

This initiative has led to other changes within the company. “We have done presentations on our accomplishments with this project,” Huseby adds. “Partly because we were able to automate our processes so successfully, IT has recently launched a number of other technology-automation initiatives for other treasury processes.”