Client Testimonials

We couldn’t be more honored to have numerous CRS clients go on record about their experiences working with our team.

I am extremely pleased with the exceptional services provided by Clinical Research Strategies (CRS). Their expertise and guidance have been instrumental in navigating the complex landscape of medical device regulations and clinical trials.

From the moment we engaged their services, the team at CRS demonstrated their deep understanding of the regulatory requirements and their commitment to excellence. They provided valuable insights and strategic recommendations that helped streamline our regulatory processes and ensure compliance every step of the way.

The professionalism and attention to detail exhibited by CRS were outstanding. Julie Cramer, PhD meticulously reviewed our documentation and helped us develop comprehensive clinical strategy.

I highly recommend CRS to any medical device company in need of regulatory and clinical support. Their professionalism, expertise, and commitment to excellence make them a trusted partner in navigating the complex regulatory landscape.

Ella Helgeman

Director, Regulatory Affairs and Quality Assurance, Nowwell AS

As the Chief Technology Officer of Entac Medical Inc., this testimonial expresses our profound appreciation for Clinical Research Strategies (CRS). Our collaboration with CRS has been transformative, setting a benchmark in our clinical trial processes and outcomes.

When we sought an experienced partner to design and manage our medical device clinical trials, CRS emerged as the gold standard. With their wealth of knowledge and expertise, they meticulously worked with us, providing crucial support in trial design, trial management, EDC management, and statistical support. It’s worth mentioning that their attention to detail, remarkable efficiency, and cost-effectiveness have been instrumental in expediting our trials while maintaining the highest levels of quality and compliance.

At the helm of CRS is Alethea Wieland, President and COO, whose leadership style embodies professionalism and commitment. Alethea goes above and beyond to deliver on promises and keeps an unwavering focus on cost containment, ensuring we derive maximum value from our partnership. Her energy and passion have undoubtedly played a significant role in CRS’s success, and we’ve been fortunate to experience this first-hand.

One individual who stands out in the CRS team is Alyssa Harris. As the project lead, Alyssa has been nothing short of phenomenal. Her expertise is paired with a dedication to excellence and a detail-oriented approach, making her a true asset. She seamlessly blends professionalism with congeniality, making every interaction a pleasure. Under her guidance, our projects have progressed smoothly and efficiently, bolstering our confidence in the success of our clinical trials.

In summary, our experience with CRS has been exceptional. Their commitment to providing top-notch clinical research strategy and execution has helped us navigate the complexities of medical device clinical trials. We highly recommend CRS to any life sciences company in search of a capable and reliable partner in the clinical research field. With CRS, you’re not just getting a service provider – you’re gaining a partner committed to your success.

John W. Cromwell, MD

CTO and Founder, Entac Medical Inc.

Based on a recommendation, I reached out to Clinical Research Strategies (CRS) to prepare a Breakthrough Device Designation submission for the FDA. The CRS team was very responsive, knowledgeable, efficient, and supportive throughout the submission process, and a Breakthrough Device Designation was granted by the FDA within 3 ½ months after first contacting CRS. CRS has also been involved in the development of key strategic research partnerships and collaborations with favorable traction. It has been very rewarding and productive collaborating with the CRS team, and I welcome the chance to work on new projects with CRS as these opportunities arise.

Ricardo Mancebo, PhD

CEO and Founder, GenEndeavor LLC

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.


CSO, 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.


Pittsburgh Marketing Professional and Innovation Futurist

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.


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.


Medical Device Founder and CEO

Clinical Research Strategies (CRS) has invaluable insight into managing CROs for Sponsors, which includes their extensive experience in clinical research. They were able to help us detect what were discrepancies or unnecessary charges, and negotiate more favorable terms in our contract, ultimately saving us over more than a third of a million dollars.

Sean McDonald

CEO and Serial Entrepreneur, Ocugenix

Clinical Research Strategies has provided critical guidance for helping us understand the FDA approval landscape, develop our strategy through their Regulatory Pathway Assessment, and then helping us every step of the way with the logistics of obtaining FDA approval. They have decades of experience, and it really shows in their expertise and thoroughness. They strive to understand our unique needs and customize their offerings. This is my first time navigating the FDA approvals pathway and having consultants you trust is so important. CRS has provided quality guidance and made me feel supported every step of the way, and I am so grateful to them!

Anna Li

CEO and Founder, Korion Health

The M2D2 IMPACT accelerator is a federally-backed program that brings together best in class biotech and medtech startups to support bringing their solutions to market faster and more efficiently. Clinical Research Strategies has been an integral partner since the IMPACT accelerator program launched, providing a combination of education sessions and mentorship to help early-stage biotech and medtech founders navigate the complex challenges involved with clinical trials. Their case driven insights and tailored support have been invaluable for startups to become more investor ready and to de-risk their pathway to regulatory approval.

Richard Meiklejohn

Innovation Leader, M2D2

In the last two projects we worked with CRS on, we have been impressed with their industrial expertise, high quality work product, and fast turnaround time. They went extra miles to cater for our business needs. We are looking forward to working with CRS on the next project!

Clinical-stage Oncology Biotech


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


RADx-Tech, Team Lead, NIH

Your team is fantastic and amazing to work with.


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.


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.


VP of Quality and Regulatory, Oncology Company


We are with our clients for the long haul — the ups and downs — supported by resilience and pragmatism.

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