WE’RE HIRING!

Join the Clinical Research Strategies team of talented and accomplished professionals serving the Life Sciences industry.

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.

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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.

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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.

“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.

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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

JUNE 2022

Eye Exam and DNA Helix

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!

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