“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.
CLINICAL RESEARCH STRATEGIES
An End-to-End Approach to Compliance in Life Sciences
Life Sciences Review, March 2021
“In the EU, while regulations are meant for ensuring patients’ safety by adding more conformance requirements, they have severely compromised the Life Sciences industry’s quest to push the boundaries of innovation,” says Alethea Wieland, the President and Founder of Clinical Research Strategies.
According to a study published by Deloitte, “Globalization, alliances and partnerships, heightened transparency expectations, increased emphasis on innovative technologies, and ever-evolving needs for existing and emerging customers are driving them to re-examine their approach to compliance.”
As such, identifying, analyzing, and mitigating compliance risks have evolved into a fundamental prerequisite for Life Sciences companies in developing an effective strategy to help future-proof their business. However, keeping up the innovation pace with this regulatory landscape will no longer be an easy task, especially for startups and mid-sized organizations.
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.
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.