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

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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.

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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.

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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!

THE LATEST FROM CLINICAL RESEARCH STRATEGIES

EVENTS & MEDIA

FDA Roundtable Ad

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

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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

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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.

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