RefleXion is an emerging therapeutic oncology company working to develop novel solutions for cancer treatment. Their SCINTIX™ biology-guided radiotherapy technology (recognized last year by the U.S. Food & Drug Administration as developing a Breakthrough Medical Device for treating lung tumors), detects tumor emissions allowing for precise targeting of radiation therapy. As they set out to launch their initial clinical studies, they searched for a partner that offered both the technology needed to run complex oncology programs, as well as the ability to identify and solve problems quickly.
“Starting out, we needed a partner that could help us build our database but also had the ability to stick with us over the course of our trials and help with updates and enhancements,” said Didem Aksoy, Senior Director of Clinical Affairs at RefleXion. “We looked at a number of potential partners but were impressed with Medrio’s professionalism and felt that they truly understood our mission.”
Speed is Key
The team at RefleXion, excited about the potential of their SCINTIX™ technology to improve the effectiveness of radiotherapy to help more patients regardless of cancer stage, wanted to be able to launch studies as quickly as possible. They looked to Medrio to help get them set up with a robust Electronic Data Capture (EDC) system, establish a platform for collecting electronic patient-reported outcome assessments (ePRO), and provide process guidance for provisioning data collection devices to sites and patients.
“Medrio was able to accommodate quick turnarounds with our studies,” Aksoy said. “They helped make sure that EDC setup and building our study database happened on time.”
While RefleXion, like many sponsors, works closely with a full-service contract research organization (CRO), they wanted to maintain a high degree of visibility over their studies. Medrio enables them to stay on top of data collection and to take advantage of the ability of the Medrio platform to produce custom reports.
“We love the benefits we get from working with a CRO but, being a newer company, we wanted to maintain a degree of oversight to fulfill our responsibilities as study sponsor,” Aksoy said. “This way, we would be able to more quickly see what strategies work well and what may need to be improved upon.”
Flexible and Responsive
When RefleXion encountered the need for changes in their first studies, they sought assistance from Medrio’s Professional Services team to provide guidance and support throughout the study build process and to help make adjustments over the course of their trials. Medrio’s team was quick to respond, helping to make mid-study updates, corrections, and enhancements rapidly.
“With these initial trials, we expected some changes or tweaks would be necessary along the way,” Aksoy said. “With Medrio’s team being so attentive, we could implement any needed updates or other changes without having to slow or even pause the study.”
Reducing Patient Burden
To get studies started as quickly as possible and to meet study enrollment goals and metrics, RefleXion knew they needed to offer research experiences that made participation more accessible and convenient for patients and sites. This meant being able to seamlessly provision devices such as tablets and smartphones to sites and patients for data collection both in the clinic environment and in patients’ homes. It also meant allowing patients and caregivers to engage via a study app from their existing devices.
“It is important, both in terms of recruiting patients and keeping them engaged over the course of a clinical trial, that we allow them to submit data in a way that is easy and comfortable,” Aksoy said. “Similarly, the EDC and ePRO solutions help to reduce the burden for our site partners, allowing them to enter and access data with a high degree of accuracy and eliminating the need to chase down paper records.”
According to Aksoy, Medrio has helped make her team’s lives much easier, due in large part to the responsiveness of their team and their willingness to jump in and help whenever called upon. With multiple studies now on the Medrio platform, she credits the Medrio support team with helping RefleXion take fast advantage of features like the capability to build libraries of useful forms and documents, such as ePRO questionnaires, that can be easily transferred over to new studies.
“What I like most is the flexibility of the Medrio team. Since our studies are novel, we may encounter the need for small changes that we weren’t expecting, and our partners at Medrio are always there to help,” said Aksoy. “It makes us feel like we’re not just another sponsor and that Medrio is just as committed to our mission as we are.”