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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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Julie earned her PhD from the University of Pittsburgh in Pathology, with a focus on intestinal stem cells and their link to intestinal cancer. When the opportunity came to join a local life sciences startup that had licensed a technology from the University of Pittsburgh, she embraced the challenge and quickly came to understand how it takes careful management of a cross-disciplinary team to navigate the often turbulent entrepreneurial waters.

Dr. Cramer then returned to her alma mater to work in commercial translation at the University of Pittsburgh’s Innovation Institute. Acting as liaison to the University’s close clinical partner, UPMC, Dr. Cramer managed diverse programs, including digital health and immunotherapy, to enable nascent technologies to mature into valuable intellectual property ready for licensing.

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.

Ms. Foust earned a bachelor’s degree in biochemistry and molecular biology from The Pennsylvania State University. Ms. Foust began her career working at a CLIA-certified molecular medicine laboratory handling complex molecular assays and systems. She prepared sequencing libraries while also testing and evaluating new reagents and controls. Her career growth enabled her to move into GLP genetic toxicology assays, quality assurance, and report generation.

Kaysie moved from North Carolina to Pittburgh to work at Noveome Biotherapeutics (formerly Stemnion Inc.) where as a quality control analyst II, she spearheaded cGMP and cGLP work that supported product development. Her next move was with Interpace Diagnostics as a senior laboratory technologist, followed by a position as specialty laboratory technologist at the University of Pittsburgh Medical Center (UPMC) Genome Center. Prior to joining CRS, Ms. Foust worked at ALung Technologies in Quality Assurance.

In her spare time Kaysie volunteers for Lake Erie and Presque Isle clean-up initiatives and is passionate about supporting animal shelters.

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.

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.

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.

Jennifer earned her doctorate of pharmacy from the University of Rhode Island, School of Pharmacy. She recently completed a 5-month long internship with CRS and landed her role by proving exceptional performance, know-how, and character.

Dr. Le currently serves as a project lead at CRS where she is involved in clinical trials for medical devices and drugs, regulatory submissions, and medical writing. She has experience managing clinical data, writing documents such as informed consent forms, preparing 510k submissions, and facilitating correspondences with the FDA. Dr. Le enjoys utilizing her pharmaceutical knowledge and critical thinking skills at CRS to provide exceptional clinical research services to our clients and continue fostering innovation.

Dr. Laura Lund is an accomplished medical device development and commercialization expert, having spent significant time in the industry as a mechanical bioengineer, including extensive experience in global regulatory and clinical strategy, both pre- and post-market. She has expertise in journal publications, regulatory submissions, sales and marketing materials, IP development, training materials, investor decks, collaborations with medical advisory boards, and presenting at conferences. She is well-versed with the design, implementation, and regulatory requirements for pre-clinical in vitro and in vivo testing.

Dr. Lund’s therapeutic areas include drugs, biologics, and medical devices in the following areas: critical/intensive cardiopulmonary care, mechanical ventilation, ECMO, ECCO₂R, artificial hearts (LVAD, RVAD, TAH), intra-aortic balloon pumps, central venous catheters/cannulation, continuous dialysis, high-pressure contrast injection, imaging, digital therapeutics, COVID-19 in vitro diagnostics; COPD, ARDS, acute respiratory failure, asthma, cystic fibrosis, heart/lung transplantation; Digital Therapeutics, Software as a Medical Device (SaMD), In vitro Diagnostics (IVDs); 3D bioprinted regenerative medicine; central nervous system (CNS); oncology; and many more.