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PRESIDENT, CHIEF OPERATING OFFICER & FOUNDER

Alethea brings 30-plus years of expertise in analyzing the intersection of healthcare innovation and policy; providing flexible clinical trial resourcing; developing sustainable corporate affairs programs and policies; training and managing resilient, high-performing clinical operations teams; mitigating risks of clinical trials; and facilitating transparent, accountable sponsor-CRO partnerships. She is the recipient of the 2017 Governor Tom Wolf Recognition in PA Life Sciences, 2017 Women in Bio P.O.W.E.R. Award, and 2017 Pittsburgh City Council Recognition in Life Sciences.

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CHIEF QUALITY AND REGULATORY OFFICER & FOUNDER

For more than three decades, David has been an innovative and transformative leader with progressive accomplishments in Quality Engineering, Quality Assurance, and Quality Management for market-leading technology and medical device manufacturers. He brings to CRS a proven track record of assuring customer quality satisfaction and improving profitability by identifying critical priorities, marshaling commitment, and managing cross-functional teams to successfully execute. David is results-driven by solving complex problems, driving change, and fostering and enabling quality culture for learning and improvement.

Dr. Nisha earned her PhD from Carnegie Mellon University in biological sciences and is 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, Parul contributed to the updates of 100+ products under the new European Medical Device Regulation (EU MDR) requirements. She is also a senior member and mentor of the Pittsburgh Chapter of Women in Bio and remains actively involved with community outreach that fosters programs in STEM.

SENIOR CLINICAL AND REGULATORY AFFAIRS PROJECT LEAD

Lauren earned her master’s degree from the University of Maryland in Neuroscience and is a certified Project Management Professional (PMP) with 8+ years of experience in pharmaceutical interventional clinical research and 6+ years from a large Contract Research Organization (CRO). Lauren contributed to a landmark article in late 2019, entitled, “Blockchain Compliance by Design: Regulatory Considerations for Blockchain in Clinical Research,” with Wendy Charles, PhD, Sean Manion, PhD, and Natalie Marler, MEd.

She has expertise in life cycle risk management, trial management, team-building, revenue recognition, and both vendor and client relationships. Her experience includes Early Phase trials in Healthy Normal Volunteers; Non-Medicated Device Trials, and Trial Designs – First-In-Man/First-In-Human, Drug-Drug Interaction, Food Effect, Thorough QT/QTc, Bioequivalence, Bioavailability, Pharmacokinetics / Pharmacodynamics / Pharmacogenetics, as well as later phase clinical trials.

Alyssa earned her master’s degree from the University of Pittsburgh in Health, Physical Activity and Chronic Disease (research track) and joined our team as an experienced project lead in a federally funded research program in premature newborn critical care indications at UPMC Magee Women’s Hospital. Prior to UPMC Magee Women’s Hospital, Alyssa worked for the University of Pittsburgh’s Healthy Lifestyle Institute as a researcher and instructor involved with study protocols and other intervention sessions for adults in a variety of weight control and physical activity programs.