INSTILL FISCAL DISCIPLINE AND REDUCE RISKS

in Your Clinical Development and Quality Programs

INSTILL FISCAL DISCIPLINE AND REDUCE RISKS

in Your Clinical Development and Quality Programs

“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

Petrie Dish with Sprout

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.

THE HUXLEY MORTON PODCAST

Series 3 Episode 5 – August 4, 2021
Addressing the unmet needs of the life sciences sector!

James Fowl interviews Alethea Wieland, Founder and President of Clinical Research Strategies

This podcast helps Pharma & Biotech industry professionals to learn from others sharing their insights from all over the world. It’s perfect for both aspiring leaders and experienced individuals looking to help make a positive impact in the world of Clinical Trials.

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.

Life Sciences Review Article

“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.

ESSENTIAL GUIDE

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.

CRS Essential Guide Cover

TOGETHER, WE CAN TRANSFORM THE CLINICAL DEVELOPMENT AND REGULATORY STRATEGY OF YOUR MEDICAL PRODUCT.

Sprouts in Test Tubes

WHAT CRS CLIENTS ARE SAYING

“Your input has been critical to our entire development team. Thank you for working at such short notice on so many things with this whole team, mad schedules and last-minute work requests. I got so many positive overflowing reviews about you from the consultants in separate follow-up calls today for your recent guidance and counsel. We bless our stars every day that we met you!! I wanted to relay the feedback back to you, thank you for everything you are doing and for carving out so much focused time for us.”

J.A. | CSO of COVID-19 Test Platform Developer

“I worked with Alethea on a blockchain project specific to her expertise and thought leadership in clinical research. Through her understanding of the healthcare industry’s growing interest in blockchain technologies for data applications and relevancies to my central research, I gained insight and a valued perspective that contributed to the discovery phase of my project team’s conceptual strategy. I appreciate her support of life science startups, as well as her dedication to advancing innovation through seeking truth to influence beneficial change.”

M. B. | Pittsburgh Marketing Professional and Innovation Futurist

“Thanks to you and your team, Alethea. I know mPOD really enjoyed working with you and the quality of your work was excellent.”

J.W. | RADx-Tech, Team Lead (NIH)

“We learn such a tremendous amount from you. Thank you for sharing the resources on patient-centricity, real-world evidence and the FDA’s vision on digital health. Honestly, we learn more speaking to you for one hour than a day’s worth of research! We truly appreciate your advice from both an extensive clinical and market strategy perspective.”

R.S. | Digital App CEO

“Your bid was the most detailed and quickly became the measurement with which all other competitors were judged. While some executives like a summary of costs, I respected the numbers you provided because they were real, and it showed you really considered the specifics about my device trial. And, you gave us pause to not fall in love with our own ideas surrounding enrollment rates.”

B.L. | Medical device founder and CEO

“Your team is fantastic and amazing to work with.”

M.N. | Medical device founder and CEO

“You have proven multiple times that you are in it with your sleeves rolled up and without complaint. Thank you for your practical advice and all that you do for my start-up.”

P.K. | Healthcare IT company founder and CEO

“You have been a joy to work with on these GDPR and privacy matters, and we appreciate your flexibility and availability to our more pressing needs.”

B.D. | VP of Quality and Regulatory, Oncology company

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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CONTACT US TODAY!

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