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 earned her PhD from Carnegie Mellon University in biological sciences and is a former NIH fellow whose scientific pursuits include 15+ years in genetics, epigenetics, molecular, and cellular biology research. She also conducted pre-clinical drug development and immunology research at the UPMC Children’s Hospital of Pittsburgh. Parul brings significant medical device industry experience from Philips Healthcare, a Top 10 global public healthcare company operating in critical care, ventilation, sleep, respiratory fields, and other therapeutic areas.

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. More recently, Parul contributed to the updates of 100+ products under the new European Medical Device Regulation (EU MDR) requirements. She is also a senior member and mentor of the Pittsburgh Chapter of Women in Bio and 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 earned her master’s degree from the University of Pittsburgh in Health, Physical Activity and Chronic Disease (research track) and joined our team as an experienced project lead in a federally funded research program in premature newborn critical care indications at UPMC Magee Women’s Hospital. Prior to UPMC Magee Women’s Hospital, Alyssa worked for the University of Pittsburgh’s Healthy Lifestyle Institute as a researcher and instructor involved with study protocols and other intervention sessions for adults in a variety of weight control and physical activity programs.

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.

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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