INSTILL FISCAL DISCIPLINE AND REDUCE RISKS

in Your Clinical Development and Quality Programs

INSTILL FISCAL DISCIPLINE AND REDUCE RISKS

in Your Clinical Development and Quality Programs

“We should not allow it to be believed that all scientific progress can be reduced to mechanisms, machines, gearings, even though such machinery also has its beauty. Neither do I believe that the spirit of adventure runs any risk of disappearing in our world.”

— MARIE CURIE

LIFE SCIENCES CONSULTING SERVICES

Owned and operated in the US, Clinical Research Strategies is a contract research organization and executive management consultancy for start-up and mid-size life sciences companies. Project-specific, fit-for-purpose, ad hoc consulting, and staffing your clinical trials is what we do best no matter where you are in your clinical development program.

COMPLIANCE, GOVERNANCE & DUE DILIGENCE

CLINICAL & REGULATORY AFFAIRS

RISK MANAGEMENT & QUALITY ASSURANCE

CRO & SPONSOR STAFFING

POLICY & INNOVATION

SERVICES

PHARMACEUTICAL COMPANIES

Protect your proprietary information while complying with transparency regs

International public disclosure regulations require that trial documentation be published in the public domain upon market authorization. Ensuring that your drug dossier is sufficiently redacted to protect your proprietary information is a complex and tedious task.

Clinical Research Strategies can alleviate the burden of redacting your clinical study reports, protocols, and similar documents. Our experts understand what is considered proprietary and can effectively ensure that your information is adequately protected.

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“Our mission is to improve your business’ performance and provide a successful clinical research development plan and strategy.”

We are with our clients for the long haul — the ups and downs — supported by resilience and pragmatism.

MEET OUR TEAM

TOGETHER, WE CAN TRANSFORM THE CLINICAL DEVELOPMENT AND REGULATORY STRATEGY OF YOUR MEDICAL PRODUCT.

WHAT CRS CLIENTS ARE SAYING

“CRS has invaluable insight into managing CROs for Sponsors, which includes their extensive experience in clinical research. They were able to help us detect what were discrepancies or unnecessary charges, and negotiate more favorable terms in our contract, ultimately saving us over more than a third of a million dollars.”

Sean McDonald | CEO and Serial Entrepreneur, Ocugenix

“I am extremely pleased with the exceptional services provided by CRS. Their expertise and guidance have been instrumental in navigating the complex landscape of medical device regulations and clinical trials.”

Ella Helgeman | Director, Regulatory Affairs and Quality Assurance, Nowwell AS

“CRS has provided critical guidance for helping us understand the FDA approval landscape, develop our strategy through their Regulatory Pathway Assessment, and then helping us every step of the way with the logistics of obtaining FDA approval.”

Anna Li | CEO and Founder, Korion Health

“Our experience with CRS has been exceptional. Their commitment to providing top-notch clinical research strategy and execution has helped us navigate the complexities of medical device clinical trials … With CRS, you’re not just getting a service provider – you’re gaining a partner committed to your success.”

John W. Cromwell, MD | CTO and Founder, Entac Medical Inc.

“CRS has been an integral partner since the IMPACT accelerator program launched, providing a combination of education sessions and mentorship to help early-stage biotech and medtech founders navigate the complex challenges involved with clinical trials.”

Richard Meiklejohn | Innovation Leader, M2D2

MORE TESTIMONIALS

Let the CRS team help you manage and overcome complicated trial operations and burdensome regulatory pathways.

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THE LATEST FROM CLINICAL RESEARCH STRATEGIES

Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe

DIA’s Therapeutic Innovation & Regulatory Science — February 10, 2024

Alethea Wieland, president of CRS, contributed to this unique real-world evidence (RWE) study for regulatory decision making with the European Medicines Agency (EMA). This case study demonstrates successful use of RWE to address a previously identified gap raised by the CHMP during the review of an earlier MAA, which led to the approval of abaloparatide in the European Union (EU) under the trade name Eladynos for the treatment of osteoporosis in the EU.

READ THE ARTICLE

RECENT EVENT

PITTSBURGH REGIONAL SCIENCE & ENGINEERING FAIR

Carnegie Science Center, One Allegheny Ave., Pittsburgh, PA 15212

The 2025 Pittsburgh Regional Science & Engineering Fair (PRSEF) on April 1-2, 2025 invites middle and high school students to take on the challenge of designing, implementing, and communicating an original experiment while competing for cash prizes and scholarships.

Clinical Research Strategies was proud to be a co-sponsor of the 2025 PRSEF. We also awarded two students with a certificate and cash award for excellence.

EVENT RECAP

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