POLICY & INNOVATION
At our inner core is the field of regulatory science. As regulatory scientists, we stay ahead of the curve by listening to the regulators challenge industry to work together toward research innovation.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research famously said that clinical trials are broken, and we could not agree with her more.
There is no better time than the present to think outside the box and use technology and more novel methods to reduce the time a product is approved. We view the deft interpretation of newer regulations and guidances as means to get there with you.
Our founder is heavily involved with newer solutions that have begun to replace the familiar methods of the past:
- Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?
- EHR-to-EDC Interoperability
- Real-World Evidence (read HERE and HERE) to inform regulatory decision-making
- Blockchain, AI, IoMT: Impact on Life Sciences and regulatory policy, including voluntary participation in the IEEE’s blockchain data standards group for clinical research
- The intersection of clinical research and value-based healthcare
- Emergency Use Authorizations (EUAs) for COVID-19
- NIH 2020 Rapid Acceleration of Diagnostics (RADx) Faculty Member and Infrastructure Team
- Fast-track SBIR grants
COVID-19 exposes Research Inefficiencies
To many of us in the industry who preached newer ways to conduct research with technological advances for years, it was no surprise when COVID-19 exposed the inefficiencies in research on a global stage. The largest pharmaceutical companies halted major trials, the FDA provided guidances on maintaining data integrity and patient safety, multiple federal agencies created unprecedented acceleration programs to develop drugs and diagnostics in warp-speed, and countless staff in sponsors and CROs lost their jobs. Virtual conferences saturated the landscape for de-centralization, hybrid studies, real-world evidence, telemedicine and home visits. While they were helpful to a certain degree, it is clear the problems we face need egos to be retired and legacy middlemen to fade away. We embrace the change and, in fact, are so excited to volunteer time to the IEEE blockchain data standards group for clinical research. We challenge you to step up and be part of the solution, too.
MARKETS AND POLICIES ARE EVOLVING. WE’LL HELP YOU KEEP UP WITH THEM.
Contact us today for a free phone consultation.