Meet Me in 5: A Cross-Organizational Team Delivers a COVID-19 Study in Record Time

“I support our European team and partner with our three U.S.-based clinical pharmacology clinics to help clients with their First-in-Human trials,” explained James. “Usually when a client would like to work with us, we put together a proposal within five to ten business days.”

For this COVID-19 project, James and his team had just one day to propose the budget for the client’s nine separate studies. “With my team members, and drawing on our past experience with these studies, we worked for the next 14 hours and by 10:30 that evening, we had created our estimates and sent it to the client,” he said.

James recognizes the effort and the energizing purpose of his team’s work. “This project really hit home about why our work matters. We are already dosing in the clinic, and seeing that side makes you realize what an important job you are doing and makes you proud to work for the company.”

On the regulatory side of the COVID-19 project, two of Alicia’s team members sprang into action to convert the client’s U.S.-based CMC documentation into the format for a Clinical Trial Authorization (CTA) for the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K.

“In a typical study review, the MHRA provides approval after 14 days for a normal healthy volunteer study, but with the urgency of COVID-19, they enabled a much more collaborative process. We did a rolling submission with the MHRA, going back and forth to comment, correct and perfect the core documents. My team moved like wildfire and worked long hours to complete the client’s investigational medical product dossier (IMPD) to get an approved CTA within just three days,” Alicia explained.

“The speed we achieved for the client was pretty amazing,” she said. “It’s a really exciting time in the regulatory space with the collaboration we are seeing between government agencies, sponsors, scientists and CROs. Everyone’s really coming together to take this on.”

Bola’s team was asked to evaluate the proposed study and determine where they could use remote and virtual trial elements, such as telemedicine/telehealth, electronic consent forms (eConsent), mobile phlebotomy (blood draws) and mobile nursing services, in downstream trials after the First-in-Human study.

“Our experienced decentralized clinical trial team dissected the client’s protocol to understand which activities could be conducted without a patient visiting an investigator site, which is a significant challenge with the COVID-19 crisis,” explained Bola. “Adding virtual technologies and methods in a trial can actually increase patient engagement by reducing their burden of traveling to an investigator site, but it also can help the client optimize their data collection during study execution and ensure safety monitoring of the trial can continue.”

Bola recognizes the importance of his team’s work to increase patient outreach through decentralized clinical trials. “We’re in the business of bringing innovative therapies to market to save lives, and I’ve seen how the importance of our everyday work across the LabCorp enterprise has been reinforced during the COVID-19 pandemic. I feel very fortunate to be a part of a group dedicated to improving the lives of patients and accelerating a cure for diseases, like COVID-19, that are impacting the entire world.”

Marie was the first costing director at Covance and over the last decade has worked to develop the budgets for many large drug development studies – including a major blockbuster drug. Creating a detailed budget typically requires two weeks as her team accounts for many factors, such as the complexity of the trial, patient inclusion/exclusion criteria, dropout rates and the number of sites needed to support the study.

“The call came in one morning and we costed the entire program for the biotech company within eight hours. We had never done that before,” explained Marie. “Out of crisis comes innovation, and we rose to the top to work collaboratively while under pressure. This assignment really made us work outside of the box.”

Since the initial development of the budget, Marie’s team has developed a new algorithm for their costing tools to automatically include back-up study sites supporting quicker turnaround times for additional urgent COVID-19 study budgets.

“It is exciting to know you are part of something that will positively impact people in our community. The job you do has such a rewarding aspect, and we are not just a run of the mill company. I’ve seen how nothing stays the same here ¬– you have to adapt to a new situation quickly. This project wasn’t easy, but we can handle any challenge.”

When faced with the rapid turnaround request from the biotech company, Agata and the COVID-19 Therapeutic Delivery Oversight team determined where they could help trim timelines at every level.

“We reached out to our core functional areas, asking them what they could offer for a COVID-19 study to negotiate unprecedented delivery,” said Agata. “For example, with medical writing, it typically requires twelve weeks to write the protocol and we reduced that to a maximum of 10 days, and in the case of the biotech company, we turned it around in just three days. We also identified project managers with therapeutic area experience to advance COVID-19 studies so they are ready to work on any project immediately. It was a huge effort, and I saw how everyone was really motivated and willing to go the extra mile.”

After supporting the biotech company, Agata’s team has organized their processes to deliver the same turnaround times as they continue to manage additional requests from other drug development companies.

Agata finds that her work on COVID-19 studies also highlights the importance of bioethics and the value of clinical trials. “I have a deep interest in bioethics and informed consent, which I have taught at the university for quite a while. The COVID-19 epidemic has really shown everyone how important our work is and how clinical research can truly impact everyone’s life. It makes me feel like I have chosen this mission for a reason.”