“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.
“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.
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THE LATEST FROM CLINICAL RESEARCH STRATEGIES
EVENTS & MEDIA
ROUNDTABLE:
Perspectives on the FDA Guidance for Clinical Decision Software
DATE: November 15, 2022
Clinical decision support (CDS) software is a challenging regulatory space. Should it be regulated as a device? And if it is a device, what does that mean for the software development and testing?
Device regulatory experts Alethea Wieland, President & COO of Clinical Research Strategies and Managing Expert at Advarra Consulting, and Advarra IRB Chairpersons Robert Romanchuk and Erin Odor provided an overview of the final FDA guidance, and conducted a roundtable discussion of case studies to help attendees better understand how the guidance and other device regulations might and might not apply.
EVENT FOLLOW-UP COMING SOON!
RESOURCES
Value-Based Healthcare in the United States
Alyssa Harris, MS , Clinical and Regulatory Affairs Project Lead II, Clinical Research Strategies
Jennifer Le, Pharm.D. , Clinical and Regulatory Affairs Project Lead, Clinical Research Strategies
CRS IN THE NEWS
Women in Medtech: Alethea Wieland, President, COO and Founder of Clinical Research Strategies
In October 2022, Medical Design & Outsourcing acknowledged some of the women executives providing medtech industry leadership. Their editorial team highlighted female executives who are running some of the industry’s biggest companies and startups. Read the profile on Clinical Research Strategies founder, Alethea Wieland, as she discusses what drew her to the industry, barriers women face in medtech, and what can be done to promote the greater participation of young women in the medtech industry today.
Read the Women in Medtech Profile.