ABOUT CRS

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.

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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.

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OUR MISSION

To improve your business’ performance and provide a successful clinical research development plan and strategy.

Our guiding principles are:

INTEGRITY
TRUST
COMPLIANCE
TRANSPARENCY
AUTHENTICITY
PURPOSE

MEET THE CRS TEAM

Alethea Wieland

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ALETHEA WIELAND

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.

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David Link

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DAVID LINK, MBA

CHIEF QUALITY AND REGULATORY OFFICER & FOUNDER

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.

Parul Nisha, PhD

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PARUL NISHA, PhD

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.

Lauren Long, MS, PMP

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LAUREN LONG, MS, PMP

SENIOR CLINICAL AND REGULATORY AFFAIRS PROJECT LEAD

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.

Alyssa Harris, MS

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ALYSSA HARRIS, MS

CLINICAL AND REGULATORY AFFAIRS PROJECT LEAD

Alyssa serves as a project lead at CRS and is responsible for managing multiple trials involving medical devices and drug development research in 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.

Katie Willett, MS

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KATHERINE (“KATIE”) WILLET, MS

CLINICAL AND REGULATORY AFFAIRS PROJECT LEAD

Katie earned her master’s degree from the Chatham University in Human Biology and is an experienced senior research manager in the University of Pittsburgh’s Department of Immunology, Center for Vaccine Research. Katie is completing a Master of Science in Law degree with a focused interest in business law and corporate compliance, biotechnology, intellectual property and patent law, legislation and regulation.

Most recently, Ms. Willett helped lead and manage scientists focusing on vaccine development for potential biological threats and emerging pathogens including SARS-CoV2, Francisella tularensis, Equine Encephalitic Viruses, Highly Pathogenic Avian Influenza (H5N1), as well as seasonal strains of influenza, Rift Valley Fever Virus, Yersinia pestis, Burkholderia, and Klebsiella pneumonia. She has also contributed to significant number of publications and presentations. Her work is particularly important for CRS’s early phase clinical trials program in infectious diseases and Investigational New Drug (IND) applications and in vitro diagnostics development.

Frank Falcione

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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.

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

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.
  • Health Canada
  • Technical Files and Design Dossiers

Scientific Writing

  • 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

LET’S TEAM UP TO GIVE YOU YOUR BEST SHOT AT A SUCCESSFUL LAUNCH

Contact us today for a free phone consultation.

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