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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.

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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Anna earned a bachelor’s degree in psychology Cum Laude with Honors in 2023, from the University of Pittsburgh, and established an interest in neuroscience research with brain injury patients. Anna worked for Dr. Anthony Kline at the Safar Research Center, where she studied the effects of pharmaceuticals on experimental traumatic brain injuries. Through this research, she had the opportunity to attend the SACNAS conference as a Travel Scholar and won an Outstanding Research Presentation award.

Ms. Carpio was published as a corresponding author in Experimental Neurology, for her research contributions to “A bridge to recovery: acute amantadine prior to environmental enrichment after brain trauma augments cognitive benefit.” She has experience as a clinical assistant in rehabilitating TBI patients, and as a peer specialist at Western Psychiatric Hospital, furthering her passion for neuroscience and psychology.

Zackary earned his doctorate of philosophy in Neuroscience at the Medical University of South Carolina, and completed a post-doctoral fellowship in translational psychiatry at the University of California San Diego where he researched seasonal mechanisms in depression and bipolar disorder.

Dr. Cope previously worked at Sage Therapeutics as an in vivo pharmacology scientist II for small molecule drug candidates, and participated on a multi-disciplinary team for Pre-IND meetings with the US Food and Drug Administration (FDA).

Prior to Sage Therapeutics, he also worked for the MODEL-AD Center at the University of Pittsburgh Aging Institute developing novel mouse models and biomarkers for the study of neurodegeneration.

Zackary is published in the fields of cognitive neurobiology, aging, Alzheimers/dementia, behavioral health, and addiction, among others.

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.

Dr. Fuller earned her doctorate of philosophy in bioengineering from the University of Pittsburgh’s Swanson School of Engineering while conducting extensive research in on-a-chip systems, multi-scale robotics, and precision medicine as a part of the Synthetic Biology and Biomimetics Laboratory of Warren Ruder, PhD.

Haley was a Cardiovascular Bioengineering Training Program T-32 Fellow and collaborated with interdisciplinary research teams at the University of Pittsburgh Vascular Medicine Institute and the UPMC Heart and Vascular Institute. In this role, Haley assisted with the engineering of organ-on-a-chip devices to understand and treat cardiovascular pathogenesis. She used these systems to evaluate drug-laden microrobot localization and drug release efficacy as a demonstration of microrobots as targeted drug delivery systems.

A pivotal point in Dr. Fuller’s research career was a stint as a bioprocess engineer at the National Institute of Allergy and Infectious Disease (NIAID), where she was instrumental in conceptualizing DoE and high-throughput experimental approaches for vaccine candidate purification process optimization. Her efforts resulted in the development of clinical manufacturing processes, a high-throughput resin screen, and data generation for peer-reviewed scientific manuscripts.

Sheila earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh’s School of Pharmacy, and Bachelor of Science degree from Pennsylvania State University. She has a breadth of experience in pre-clinical, clinical, and translational research focused on device, drug, biologic, and combination products for a range of indications. Additionally, she brings our clients more than five years of extensive experience in clinical trial management, regulatory submissions, pharmaceutical formulation, manufacture, characterization, and general laboratory procedures. Dr. Grab is highly adept at management consulting by juggling a variety of projects using her skills in scientific writing for SOPs, protocol development, grants, Investigator Brochures, Instructions for Use, and various other clinical-related documents, as well as regulatory research for US and international submissions. She serves as vice-chair of Young Women in Bio (YWIB) Pittsburgh Chapter and as a Women in Bio (WIB) Pittsburgh Chapter Member.

Alyssa serves as Manager of Clinical and Regulatory Affairs 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.

Ally serves as Clinical and Regulatory Affairs Project Lead at CRS. She earned her doctorate of philosophy in the Program in Microbiology and Immunology at the University of Pittsburgh, working in the laboratory of Dr. John Alcorn at UPMC Children’s Hospital.

The focus of her research was how infection with respiratory viruses, particularly influenza, can damage the host airways and lead to increased incidence of secondary bacterial pneumonia. Additionally, she completed a project to predict length of hospitalization in pediatric patients admitted to the hospital for respiratory infections.

Samantha earned a bachelor’s degree in biobehavioral health from Pennsylvania State University (PSU). She took focused coursework in Clinical Research Practice, Health Promotion II, Anatomy and Physiology II, Chemistry Principles II, Epidemiology, Genetics, Statistics, Research Applications, Diversity and Health, Bioethics, Kinesiology, Nutrition, and Psychology.

Samantha completed numerous certifications in the research and medical field, including: First Aid & CPR and Mental Health First Aid; CITI Programs Biomedical Human Subject Research (IRB) Course, FDA-Regulated Research, OSHA Bloodborne Pathogens, Shipping of Regulated Biological Material; and, Professional Development Certification for Center-Based Care (Building Blocks for Quality). Her leadership skills were honed by chairing the 2021-22 THON and coaching club field hockey. In her spare time, Samantha enjoys hiking, fishing, and anything outdoors.

As Project Lead, Sidney bridges the gap between clinical trials and regulatory strategy across multiple therapeutic areas, including infectious disease, oncology, rare diseases, and critical care medicine. She acts as lead for phase I-IV clinical trials for biologics and pharmaceuticals, pilot and pivotal medical device studies, healthy volunteer studies, and post-market real-world evidence (RWE) studies, with extensive experience managing international studies across Europe, Asia, and Australia.

Sidney earned her doctorate in Microbiology and Immunology from the University of Pittsburgh School of Medicine, where she conducted research on immune dysfunction and host-microbe interactions, resulting in several peer-reviewed publications. Outside of work, Sidney enjoys playing with her dog, yoga, bouldering, and keeping up with her favorite home renovation shows.

Dr. Mariscal earned her Doctor of Philosophy in Bioengineering at the University of Pittsburgh and was a post-doctoral researcher in the Bioengineering Department, Sensorimotor Learning Laboratory with advisor Dr. Gelsy Torres-Oviedo. After that program, she became a post-doctoral scholar in the Rehab Neural Engineering Lab within the Physical Medicine and Rehabilitation department, and assisted advisor Dr. Lee Fisher with an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA).

Dr. Mariscal also holds a Bachelor of Science in Mechanical Engineering from the Universidad del Turabo in Puerto Rico, which she earned thanks to an athletic scholarship with the university swimming team. Outside of work, Dulce enjoys spending time with her family and taking her two dogs for long walks. Dulce also likes to stay active, so she usually runs or bikes around the city.

Dr. Sundermann earned an undergraduate Biomedical Engineering degree from Vanderbilt University in 2011 and a PhD in Bioengineering from the University of Pittsburgh in 2017. Prior to joining CRS, Matt held a Senior Clinical Strategy Manager role at Smith and Nephew and a Clinical Research Scientist role at ZOLL Medical Corporation. Between 2012-2017, he was employed in the UPMC Artificial Heart Program as a Clinical and Flight Engineer.

Outside of work, Matt is active with the Explorers Club of Pittsburgh and volunteers as an instructor in the club’s backpacking, climbing, and mountaineering schools. Matt resides in the Lawrenceville neighborhood of Pittsburgh with his partner Kelly and labrador retriever named Summit.