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

Photo: Jen Worley

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.

Alethea’s LinkedIn Profile

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David Link

Photo: Jen Worley

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.

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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