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“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
MEDICA 2024
November 11-14, 2024, Düsseldorf, Germany
Alyssa Harris, Clinical Research Strategies Manager of Clinical and Regulatory Affairs, recently represented CRS at MEDICA – the world’s leading trade fair for medical technology & healthcare in Düsseldorf, Germany, where medical industry experts from more than 70 countries showcased a wide range of innovative products and services. MEDICA also had an extensive program of first-class forums, conferences and special shows that, once again, made this the industry event of the year.
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 NEWS
CRS Joins Central New York Biotech Accelerator (CNYBAC) Service Provider Network
Clinical Research Strategies is proud to be a member of the Central New York Biotech Accelerator (CNYBAC) Service Provider Network offering Regulatory/Compliance, Risk Management/Quality Systems, Startup Company Support, and University Support services.
CNYBAC is an off-campus accelerator serving for-profit pharmaceutical, biologic, and medical device startup companies who are actively commercializing a biotech-related product or service. CNYBAC is operated by SUNY Upstate Medical University – the region’s only academic medical center – and is located in close proximity to Syracuse universities and hospitals.