Decentralized Clinical Trials (DCTs) have created a whole new chapter for clinical research trials. Rather than requiring in-person visits to specific doctor offices or research locations, DCTs take a digital approach to collecting clinical data. This transforms the way research data is collected, stored, and analyzed and allows more access for participants. By including the use of new tools, from wearable devices to virtual visits and online apps, DCTs will help make clinical research more patient-centric. These changes should also have a positive impact on the overall cost of studies. Considering these upcoming options for how research can be conducted, understanding decentralized trials is imperative for the medical community and anyone impacted by research.
Our dedicated Clinical Science and Regulatory teams at Kaleidoscope are poised to support Decentralized Clinical Trials. From offering regulatory guidance and implementing robust quality management systems to overseeing data monitoring and reporting, we are equipped to address various aspects of your DCTs. Our skilled Clinical Science team specializes in device management and excels in providing remote data services from any location. Entrust us with your DCT needs, and let our teams deliver the highest quality service tailored to your requirements.
Kaleidoscope Innovation Integrates Regulatory Mark to Offer Global Regulatory Service
CINCINNATI, Aug. 17, 2022 /PRNewswire/ -- Kaleidoscope Innovation announced today that the regulatory, quality and clinical affairs consulting group, Regulatory Mark, is now part of the team at Kaleidoscope Innovation, an Infosys company specializing in the full spectrum of product design and development.
Led by regulatory industry veterans Alison Sathe and Colleen Murphy, the Regulatory Mark team will work closely with Elliott Fegelman, MD, Kaleidoscope's Chief Medical Officer and VP of Medical Affairs, to expand and streamline the design consultancy's regulatory strategy, licensing and support services. This includes leading FDA and EU MDR regulatory submissions for global regulatory licensing and ongoing compliance.
According to Fegelman, this formal partnership was a natural progression in an already strong working relationship between Kaleidoscope and Regulatory Mark. Since 2016, Kaleidoscope Innovation and Regulatory Mark have completed approximately 40 joint regulatory submission projects for medical device clients—all of which received regulatory clearance.
As the regulatory affairs market grows exponentially, Kaleidoscope projects they will triple the volume of packages they will submit for US and global EU clearance during the next two years.
"This merger allows us to offer a true total product lifecycle (TPLC) approach and integrate seamlessly with Kaleidoscope's existing best-in-class processes," Sathe and Murphy explained. "From regulatory strategy and planning at the concept stage through design and development and into post-market we can share insights to ensure efficient regulatory submissions and ongoing compliance."
"The joining of these leadership teams and capabilities will allow us to offer our medical device clients—and ultimately the patients they serve—even more comprehensive and efficient services," Fegelman explained. "We're augmenting what's already there—now with in-house, end-to-end capabilities."
Kaleidoscope Innovation, an Infosys company, is a full-service product development firm innovating across medical, consumer and industrial markets. For over 30 years clients have partnered with Kaleidoscope to improve the human experience. Offering both consultancy-style and onsite services, they provide a full breadth of disciplines to meet their partners where needed, including: Insights & Human Factors, Medical Affairs, Industrial Design & User Experience, Engineering, Visualization and Software Development.
