We CARE about your BIG dreams and limited means.
We are with our clients for the long haul — the ups and downs — supported by resilience and pragmatism.
Clinical Research Strategies is a Pittsburgh, PA-based contract research organization and executive management consultancy for start-up and mid-size life sciences companies. We help instill fiscal discipline and reduce risks in clinical development, corporate affairs, and quality assurance programs.
Project-specific, fit-for-purpose, ad hoc consulting, and staffing clinical trials is what we do best, whatever stage your program is in.
CRS advisors have been everywhere – clinical research organizations, life science start-ups, and large pharma and medical device companies.
We can help you manage and overcome complicated trial operations and the burdensome regulatory pathways to a successful product launch.
We’d love to learn about your program.
To improve your business’ performance and provide a successful clinical research development plan and strategy.
Our guiding principles are:
Clinical Research Strategies is amongst the Pittsburgh Business Times List of Largest Life Sciences Firms in the region, placing 34 in 2022. Thanks to a GREAT team!
The CRS Senior Management Team Helps Enable Growth and Awareness at the Local University Levels.
Parul Nisha, PhD, Senior Director, Clinical and Regulatory Affairs at CRS, making a difference and giving back as she presents her expertise to the next generation of Biomedical Engineering students at Duquesne University.
CRS is proud of our teammates, Julie Cramer, PhD, MS (judge) and Parul Nisha, PhD (judge), for their support of the Pittsburgh Regional Science & Engineering Fair at the Carnegie Science Center. Thank you for your civic involvement!
Julie Cramer, PhD, Associate Director of Clinical and Regulatory Affairs at CRS, presents a seminar to the University of Pittsburgh biomedical graduate students who are in the Cellular Approach to Tissue Engineering and Regeneration (CATER) program, funded by a T32 grant. Julie, a former member of the CATER program and Pitt grad student herself, says, “It feels great to give back!”
It was a great honor to be invited alongside representatives from Philips, Covestro, and ZOLL Medical Corporation to Leda Klouda, PhD’s Biomedical Engineering Department and the Biomedical Engineering Society Career Event at Duquesne University held on March 30, 2022. Our Clinical Research Strategies, LLC teammates, Brian Sullivan and Julie Cramer, were thrilled to provide highlights of their own career trajectories (education, first and subsequent jobs) and speak about our company’s products, market, and customers. Thank you, Leda Klouda, PhD and students!
MEET THE CRS TEAM
DAVID LINK, MBA
CEO AND CHIEF QUALITY & REGULATORY OFFICER
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.
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.
CLINICAL RESEARCH ASSOCIATE
David is a recent graduate from the Indiana University of Pennsylvania, earning a dual bachelor’s degree in biology and anthropology with GPA of 3.5 and a minor in Global Health. He has special training and certification in mental health and naloxone administration with a focus on populations who are underserved or forgotten in our communities. As consul president of Kappa Delta Rho, David made a difference in policy reform for the fraternity on a national level. Additionally, he was a tutor in the American Language Institute where he led initiatives to improve US culture, customs, and norms.
MANAGER OF BUSINESS OPERATIONS
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.
BHARESH CHAUHAN, D.Phil. (Oxon)
CLINICAL AND REGULATORY AFFAIRS SCIENTIST
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.
JULIE CRAMER, PhD, MS
DIRECTOR OF CLINICAL AND REGULATORY AFFAIRS
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.
SENIOR CLINICAL QUALITY SPECIALIST & AUDITOR
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 FALCIONE, EMBA
SENIOR EXECUTIVE QUALITY AND RISK MANAGEMENT CONSULTANT
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.
SHEILA GRAB, PhD
CLINICAL AND REGULATORY AFFAIRS SCIENTIST CONSULTANT
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 HARRIS, MS
CLINICAL AND REGULATORY AFFAIRS PROJECT LEAD II
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.
JENNIFER LE, PHARM.D.
CLINICAL AND REGULATORY AFFAIRS PROJECT LEAD
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.
LAUREN LONG, MS, PMP
MANAGER OF CLINICAL AND REGULATORY AFFAIRS
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.
LAURA LUND, PhD
SENIOR EXECUTIVE MANAGEMENT CONSULTANT
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.
PARUL NISHA, PhD
SENIOR DIRECTOR OF CLINICAL AND REGULATORY AFFAIRS
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 SULLIVAN, PhD, PMP
SENIOR EXECUTIVE MANAGEMENT CONSULTANT
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.
Our Supplementary Team is Ready for Your Assignment!
Project Management Directors and Project Managers
- Experts from CRO, Sponsor & Site side
- ≥ 10-20 years’ experience in research and consulting services
- Cardiovascular, oncology, regenerative medicine, CNS, women’s/men’s health, implantable devices, vaccines, infectious diseases, GI, metabolic, immuno-oncology, respiratory, rheumatology, nephrology, rare diseases… and many others
Senior Clinical Research Associates / Auditors
Experts from CRO, Sponsor & Site side
≥ 20-30 years’ experience in research and consulting services
Cardiovascular, oncology, regenerative medicine, CNS, women’s/men’s health, implantable devices, vaccines, infectious diseases, GI, metabolic, immuno-oncology, respiratory, rheumatology, nephrology, rare diseases… and many others
Senior Scientist Executives
Experts from Sponsor & Government Firms
≥ 15-30 years experience in life sciences
Drug, biologic, device, IVD, Artificial intelligence / Machine learning, software as a medical device (SaMD), usability testing
Quality Assurance Engineers and Auditors
Site, Sponsor, Vendor auditors
Quality Management Systems (QMS)
483/Warning Letter response and mitigation
Regulatory Strategies & Submissions
FDA Regulatory Agent, Pre-IND, Q-Sub, Pre-IDE, IND/IDE, 513(g), 510(k), De Novo, PMA, NDA, BLA, Breakthrough, etc.
Technical Files and Design Dossiers
EU MDR Literature Reviews and Clinical Evaluation Reports
Protocols, Investigator Brochures, Technical Documents
Medical Experts/Medical Monitors
Medical oncologists, surgeons, intensivists, internists, primary care, most other specialties covered
We are pleased to announce that David Anderson has successfully completed the Barnett CRA training course that builds the necessary foundation for his growth as a CRA and focus on site management
This is relevant to David because he was hired fresh out of college with little clinical research experience and was eager to break into the field. This course was complementary to the work he has been involved in at CRS since his start in January 2022. He was able to translate aspects of the 13-week course into meaningful contributions in the workplace. David now has more formal education and more in-depth knowledge of the roles and expectations for his position.
TAKE YOUR KIDS TO WORK DAY 2022
The Clinical Research Strategies team participates in Take Your Kids to Work Day 2022. The day is designed to help children explore the workforce and inspire them to see the different roles required to run a business or to build a project. We acknowledge our future leaders and are doing our part to introduce them to work life and what it takes to succeed.
LET’S TEAM UP TO GIVE YOU YOUR BEST SHOT AT A SUCCESSFUL LAUNCH
Contact us today for a free phone consultation.