“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.
MEDTECH Conference 2024
October 15-17, 2024
Metro Toronto Convention Centre, Toronto
Join the world’s top MedTech executives at the leading medical technology event. The MedTech Conference will help you look ahead and create new possibilities. Featuring world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology, this forum for transformational ideas is a can’t-miss event for the industry’s prominent and most promising companies.
Stop by Booth 204 and say “Hi” to the CRS Team!
“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
MEDTECH Conference 2024
October 15-17, 2024
Metro Toronto Convention Centre, Toronto
We’re joining the world’s top MedTech executives at the leading medical technology event in Toronto!
Stop by Booth 204 and say “Hi” to the CRS Team!
UPCOMING WEBINAR
WEBINAR: Power of Real-World Evidence: Accelerating Approvals in Global Markets
Wednesday, November 20, 2024
1:00 – 2:00 PM PST / 4:00 – 5:00 PM EST
RESOURCES
The Intersection of Artificial Intelligence and Neuroscience
Anna Carpio – Clinical Research Associate, Clinical Research Strategies
The Roles of Technology Companies and Large Corporations in the U.S. Health System
Jennifer Le, PharmD – Clinical and Regulatory Project Lead II, Clinical Research Strategies
CRS IN THE NEWS
“When FMVs Collide: Coming to Terms with Fair Market Value”
Applied Clinical Trials Online, January 19, 2024
With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value. As one of several experts cited in this informative article, Alethea Wieland, CEO and founder of Clinical Research Strategies, weighs in on the conflation of cost and value in the clinical research industry.