“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.
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.
WANT TO LEARN MORE?
Contact us today for a quote or capabilities presentation.
Want to Participate in the Development of a Cough Monitoring Wearable Device?
C-mo Solutions is an innovative company that has developed a wearable cough monitor. The cough monitor provides information about a patient’s cough to a healthcare provider. C-mo is interested in understanding how well users are able to receive and carry through instructions about using the monitor.
You do not need to have a cough to participate in this study.
The device testing will take place in early 2025.
“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.
TOGETHER, WE CAN TRANSFORM THE CLINICAL DEVELOPMENT AND REGULATORY STRATEGY OF YOUR MEDICAL PRODUCT.

WHAT CRS CLIENTS ARE SAYING
Let the CRS team help you manage and overcome complicated trial operations and burdensome regulatory pathways.
Contact us today to arrange a no-obligation phone consultation.

CONTACT US TODAY!
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.
UPCOMING 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 is proud to be a co-sponsor of the 2025 PRSEF. We’ll be awarding two students with a certificate and cash award for excellence.
RESOURCES

Real-World Evidence: Gaining Momentum in Clinical Research
Sidney Lane, PhD – Clinical and Regulatory Affairs Project Lead, Clinical Research Strategies

The Intersection of Artificial Intelligence and Neuroscience
Anna Carpio – Clinical Research Associate, Clinical Research Strategies
CRS NEWS

Dulce Mariscal, PhD Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – March 3, 2025

NeuroDawn’s Product Y-3 for Injection has Completed the First Subject Enrollment in the US Phase I Clinical Trial
February 19, 2025