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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.

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.

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.

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.

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.

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.

Dr. Lane earned a doctorate in Microbiology and Immunology from the University of Pittsburgh, School of Medicine, conducting extensive research on immune dysfunction and host-microbe interactions during polymicrobial respiratory infections in the laboratory of Dr. Jennifer Bomberger, PhD.

Sidney’s research led to multiple peer-reviewed publications and fellowships, including an appointment as a TL1 Clinical and Translational Sciences Fellow. In this role, Sidney expanded her clinical research knowledge through coursework and a personalized training program, allowing her to grow her passion for life sciences research translation. Following her time as a TL1 Fellow, Sidney joined the CRS team as the inaugural intern in the newly established partnership between CRS and the University of Pittsburgh. Outside of the workplace, Sidney loves to play with her dog and enjoys yoga, bouldering, and staying up-to-date on her favorite home renovation shows.

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.

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.