JULY 2023LIFE SCIENCES REVIEW 19How have you seen the med tech industry evolving in terms of technological advancements and processes? Working in the clinical trials space for over 20 years, I have observed that the challenges and opportunities evolve dramatically as digital tech changes. For instance, the advent of electronic health records has transformed paper study files into structured electronic study documents, and the integration of software applications has enabled e-consent and remote data monitoring. Using APIs, integrating software applications like e-consent and remote data monitoring, and linking electronic health records to these applications enable the concept of multiple data sources. These data sources can be anything from claims databases and clinical registries to company-sponsored projects. The information aggregated in a big data concept allows us to view not only clinical trial data but all aspects of data. Regulatory bodies can use this information to make informed decisions while evaluating the safety and performance of medical devices that impact patient care and safety. The digital solutions are across the board, creating efficiencies in data collection. In trial study monitoring, the concept of remote data monitoring applications has really taken on as a result of the COVID pandemic. This has helped in saving travel costs and having real-time access to data. The electronic data capture systems have also enabled us to monitor and evaluate the data on a real-time basis. What are the latest technologies that you are currently using for your projects? We are utilizing platforms such as electronic data capture, clinical trial management systems, and electronic trial master files. We're also working with third-party registry BIG DATA AND CONCEPT OF REAL-WORLD EVIDENCE DRIVES CLINICAL TRIALS' FUTUREAn interview with Georgia Mitchell, Director, Clinical and Medical Affairs, Stryker (Spine Division)As the Director of Clinical and Medical Affairs at Stryker's Spine division, Georgia Mitchell oversees the Spine division's global clinical evidence, strategy, and execution. This includes company-sponsored and investigator-led research, including post-market clinical follow-up activities and evidence to support Stryker's marketing claims reimbursement and market access needs. She is also associated with clinical value funds-related activities to support markets that utilize EU clinical evaluations. Georgia MitchellCXO INSIGHTS
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