Speaker Profile

Parul Nisha

Biography
Dr. Nisha is the Director of Clinical and Regulatory Affairs at Clinical Research Strategies. She earned her PhD from Carnegie Mellon University in biological sciences and joins the team as a former NIH fellow whose scientific pursuits include 15+ years in genetics, epigenetics, molecular and cellular biology research. She also conducted pre-clinical drug development and immunology research at the UPMC Children’s Hospital of Pittsburgh. Parul brings significant medical device industry experience from Philips Healthcare, a Top 10 global public healthcare company operating in critical care, ventilation, sleep, respiratory fields, and other therapeutic areas. Dr. Nisha has a rare blend of drug development and medical device expertise in all aspects of translational science, federal grants, clinical development and operations, scientific writing, regulatory affairs, and project management. More recently, Dr. Nisha contributed to the updates of 100+ products under the new European Medical Device Regulation (EU MDR) requirements.

Clinical & Research Tools:
Clinical Research Strategies
About Clinical Research Strategies, LLC: CRS is a specialty CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, attorneys, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and sales and marketing teams to take on the biggest challenges for start-up, mid-sized and large life sciences companies. Service areas are drug dossier submissions, clinical trials, Functional Service Provider (FSP) models, selection and management of CROs, regulatory compliance strategy and submissions, QMS, EU MDR and GDPR, rescue trials, TMF, risk mitigation and remediation, inspection-readiness, training high-performing teams, staffing solutions, and decentralized trials.

Indications represented are precision medicine, immuno-oncology, central nervous system, infectious diseases, respiratory diseases, orthopedics, de novo devices, IVDs, digital health and mobile apps, reproductive health, regenerative medicine, cardiology, major depressive disorder, opioid-sparing pain, cannabis, radiology, and critical care. CRS is a qualified service provider for federal grants.

Clinical & Regulatory Tools in the New Era of Regulatory-Decision Making
This presentation showcases a review of case studies under the COVID pandemic and Operation Warp Speed, with our rapid adaptations of clinical and regulatory tools to conduct studies, use real-world evidence, and move away from traditional methods that hold us back.