“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.
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.
TOGETHER, WE CAN TRANSFORM THE CLINICAL DEVELOPMENT AND REGULATORY STRATEGY OF YOUR MEDICAL PRODUCT.
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.
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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.
“Imagine a Clinical Trial System that Seamlessly Designs Trials”
December 7, 2023
Richard Landin, Ph.D., President and CEO of Telperian
Professor Brian Hobbs, Co-Founder and Advisor at Telperian
Hosted by OccamPoint’s Julia Varshavsky, Ph.D.
Proudly sponsored and moderated by CRS’ Alethea Wieland
Imagine a clinical trial system that seamlessly designs trials; monitors and continuously evaluates running trials alerting administrators of potential problems as they arise; performs analyses with no programming; and enables access and benefits patients, including those who are underserved.
Geographic Risk Factors: A Case Study on Opioid Use Disorder (OUD)
Samantha Krebs – Clinical Research Associate, Clinical Research Strategies
CRS IN THE NEWS
CRS Ranks #34 in the 2023 Pittsburgh Business Times List of Life Sciences / Medical Device Companies
The region’s biotech ecosystem remains strong in Pittsburgh — fueled by the presence of UPMC, Highmark/Allegheny Health Network and fed by the University of Pittsburgh, Carnegie Mellon University, Duquesne University and other regional institutions — as is evidenced by the companies on the List of Life Sciences and Medical Device Firms in the Pittsburgh region.