Client Testimonials

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.

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.

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.

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.

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.

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.

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.