Join the Clinical Research Strategies team of talented and accomplished professionals serving the Life Sciences industry.
“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.
CRS Founder, Alethea Wieland, Named to National Small Business Association (NSBA) Leadership Council and Participant in the Small Business Technology Council (SBTC)
NSBA is the nation’s oldest small-business advocacy organization and operates on a staunchly nonpartisan basis.
Clinical Research Strategies is amongst the Pittsburgh Business Times List of Life Sciences Firms in the region, placing 34 in 2022. Thanks to a GREAT team!
Regulatory Pathways to Clearance: Transitioning University Discoveries
School of Health and Rehabilitation Sciences Innovation Seminar Series at the University of Pittsburgh
Dr. Julie Cramer, Associate Director of Clinical and Regulatory Affairs of CRS
During this talk, Dr. Cramer provides a regulatory perspective on how to transition your device-based discoveries out of the University. She discusses topics such as how to define your medical device, differences between your device’s intended use and indication, types of device market approval applications/pathways, and Regulatory Pathway Assessments.
1. Defining your medical device
2. Intended use vs Indication
3. Types of device market approval applications/pathways
4. De-risking the process
6. Meeting with the regulators
7. Clinical evidence generation
Watch the Video Presentation
Interview: Decentralized Trials with Alethea Wieland
GCP-Service’s GCP Mindset channel informs viewers about the latest trends and topics in clinical research. Here, they take a closer look on Decentralized Trials with expert Alethea Wieland from Clinical Research Strategies.
What Most Medical Device Companies Face and How to Succeed
A first-hand view of challenges, best practices, and winning factors garnered through extensive work with early stage medical device companies.
The “Essential Guide: What Most Medical Device Companies Face and How to Succeed” has been authored by expert Alethea Wieland, Founder and President of Clinical Research Strategies.
PRECISION MEDICINE SERIES (PART 2)
Insights into the Field of Ophthalmology in Precision Medicine
Bharesh K. Chauhan, D.Phil. (Oxon)
Clinical and Regulatory Affairs Scientist, Clinical Research Strategies
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.