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Candice earned her bachelors of science (BS) in business management from North Carolina State University. She has held various roles with increasing responsibility, including in financial consulting, billing, bank reconciliation, and financial reporting for small, mid-size, and large companies. Candice and her family spend significant time giving back to their community, including with food banks and other mentoring for those less fortunate. Ms. Brett lives in North Carolina with access to numerous CRS clients, including emerging life sciences companies and other existing partnerships.

Dr. Chauhan earned his doctorate from Oxford University in Molecular Virology, where he conducted early studies in the generation of the now established baculovirus expression system employed for viral vaccines and gene therapy vectors. He came to the U.S. where he has spent the last 22 years on ocular and rare disease research yielding more than 20 peer-reviewed papers, numerous national and international presentations at research conferences, and acting as a reviewer of scientific manuscripts and grants.

At the Albert Einstein College of Medicine in New York, his research focused on cataracts, conducting both gene regulation and high-throughput gene expression analyses. While at the nationally leading Cincinnati Children’s Research Foundation, he focused on development of eye tissues important in understanding congenital ocular diseases, where he primarily utilized transgenic mouse models of eye disease with state of the art imaging devices to probe the molecular and cellular biology of anterior ocular diseases. Dr. Chauhan worked at the UPMC Children’s Hospital of Pittsburgh to translate his basic research to the bedside by primarily performing studies on human tissues.

Vonya earned a bachelor’s degree with honors from Cornell University in biological and environmental engineering, and a master’s degree from Case Western University in biomedical engineering. She began her career working to determine genes responsible for mucus production in cystic fibrosis patients, carrying out toxicity studies to determine lethal dose of novel antibiotics on mice, and developing acute lung infection mice models.

After several years in a senior research assistant role at Magee Women’s Research institute (MWRI) studying gene expression of nicotine in lung fibroblasts and differentiating embryonic stem cells, Ms. Eisinger joined Perryman Company and held several roles in quality assurance, most significantly within the medical device sector where she analyzed validation requirements, requests for information, documentation, and complaint handling under ISO standards. Ms. Eisinger also participated in ISO 9001, AS9100, ISO 13485, and customer audits.

Frank has 30 years’ experience as a senior executive working in domestic and international regulatory compliance, inspection-readiness, regulatory negotiations, quality management systems, and new product development within start-up medical device companies, military applications, and diagnostic instrumentation.

Mr. Falcione has contributed more recently to the implementation of MDD Class IIb and III devices for CE approval, transition to EU MDR conformance, and FDA Class III Modular PMA submissions. Additionally, he led quality programs for inspection-readiness, on-site and virtual audits and inspections, and face-to-face regulatory meetings. He remains actively involved in teaching regulatory/quality and product risk management at local colleges and universities and contributing to the development of young entrepreneurs.

Alyssa serves as a project lead II at CRS and is responsible for managing multiple trials involving medical devices and drug development research in critical care, GI surgery, abdominoplasty, oncology, infectious diseases, respiratory disorders, and digital therapeutics. Ms. Harris also has experience managing federally funded research programs in vulnerable populations, specifically in the neonatal intensive care unit.

Alyssa earned her master’s degree from the University of Pittsburgh in Health, Physical Activity and Chronic Disease, focusing on the research track. Her undergraduate degree is in Exercise Physiology, where Ms. Harris gained extensive experience working in chronic disease research, specifically with metabolic disorders, and leading weight loss and physical activity interventions. Ms. Harris brings a unique range of expertise to CRS, and thrives in an environment that uses new methods and tools in research.

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.

Dr. Nisha brings 20+ years of research experience spanning both industry and academia, in clinical and regulatory affairs as well as basic and translational sciences. Dr. Nisha earned her PhD from Carnegie Mellon University in biological sciences and is a former NIH fellow whose scientific pursuits include genetics, epigenetics, molecular biology, immunology, and pre-clinical drug development research.

Dr. Nisha has facilitated FDA submissions for both drugs and devices, and, more recently, contributed to the updates of 100+ products under the new European Medical Device Regulation (EU MDR) requirements. 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. Additionally, she has experience with multiple indications: respiratory and sleep, cardiovascular, ophthalmology, dermatology, metabolic disorders, pediatric immune disorders, precision medicine, regenerative medicine, and digital health. Dr. Nisha also remains actively involved with community outreach that fosters programs in STEM.

Brian has 30 years of experience ranging from basic biological research, to software engineering, to mid- and upper-level management, with multiple C-level positions, including CEO and COO. Specific areas of expertise include artificial intelligence/machine learning, software as a medical device (SaMD), biologics manufacturing, user centered system design, V&V, hardware manufacturing, field install/training/maintenance, sales and marketing, audit, project management, process improvement, regulatory and quality. These efforts have occurred in large global multi-nationals, in mid-sized companies, in small companies, and in startups.

Dr. Sullivan focuses on the integration of multiple operational perspectives to guide clients toward approaches that simultaneously consider and avoid relevant pitfalls. A typical example includes optimizing a regulatory approach to consider detailed technology, operations, schedule and budget goals, and resulting constraints.