Testimonials
Reviews of Clintrex by Our Customers
"Clintrex was an essential partner in Acorda’s successful development of our Parkinson’s drug, Inbrija, which led to timely FDA and EMA approvals. They are, hands down, the best group I have seen for help with any aspect of neurological drug development, including preclinical testing, clinical strategy, design and execution, regulatory interactions and approval, and post-commercial strategy and guidance. They brought us the highest possible level of international neurology and regulatory expertise, and we appreciated the deep collaborative nature of their interactions with us, as well as their patient-centeredness and integrity. "
- Ron Cohen, M.D.
President and CEO, Acorda Therapeutics, Inc.
"We brought the team at Clintrex in as expert consultants during the pre-clinical phase of the development of our lead program. They provided essential insights into the interpretation of our data. We retained them for the design and conduct of our Phase Ia clinical program, and their input during discussions with the FDA was critically important. The successful enrollment and final study results from the first-in-man study of SER-214 in Parkinson's patients have positioned our company for continued success. We have no hesitations about advancing our next Parkinson's candidate drug with this team. They are simply the best"
- Randall Moreadith, Chief Executive Officer
Serina Therapeutics
"I had the pleasure of working with Clintrex while I was the Chief Medical Officer at Cynapsus Therapeutics. The strategic support and operational guidance that Clintrex provided were foundational for Cynapsus for both its IPO and its eventual acquisition. Our success can be attributed to their clinical and regulatory acumen"
- Albert Agro, Ph.D., Previous CMO of Cynapsus Therapeutics, Now the current CEO Sublimity Therapeutics
Cynapsus Therapeutics (Now Sunivion)
"It has been our pleasure to work with the Clintrex leadership during the three years preceding our IPO in which time we launched a critical phase 2 study in Huntington’s disease. The advice and guidance we received from Clintrex on study design set the ground for generating data that supported the value of our lead product and stimulated interest from both clinicians and investors. This facilitated both successful enrollments in our study and the conclusion to our financing. We look forward to continuing to work with Clintrex as we expand the range of applications of our product to other neurodegenerative diseases"
- Maurice Zauderer, Ph.D., President & CEO
Vaccinex, Inc
"SynAgile became a Clintrex client when we were a startup with an unproven concept. Since that time Clintrex has functioned as SynAgile’s clinical arm, running our first clinical trial on a complete turnkey basis from design to regulatory approval to study execution. Along the way, we learned to trust the integrity, judgment, implementation ability, and deep neurology expertise of the Clintrex team. We found that for Clintrex their goal is not just to execute a clinical trial, but rather to ensure that SynAgile succeeds. Clintrex is now running SynAgile’s second clinical trial."
- Ephraim Heller, CEO
Synagile Corp
"The Clintrex Team has been helpful both strategically as well as operationally. It’s rare that you find an organization that can help in both identifying issues as well as solving them. We’ve been fortunate to work with Clintrex in helping advance an important therapy to market."
- Jeff Meckler, CEO and Vice Chairman of the Board
Intec Pharma
"Since 2010, Pharma Two B has been working with Clintrex in developing our combination product as a treatment for PD. We sought clinical consultants that will not only be the best experts in PD but will also have expertise in preclinical studies, drug development, and regulatory strategy. We have found all this, and more, in Clintrex. They have helped us to evaluate our preclinical results, joined with us at FDA and European regulatory meetings, designed the clinical protocols, selected the best clinical sites and investigators, and conducted training at the investigator's meetings."
- Nurit Livnah, Ph.D, Former CEO
Pharma Two B Ltd
"The clinical, regulatory, and statistical insights of the Clintrex team provided to Avadel during a critical point in our phase 3 program was invaluable. Their recommendations and execution support resulted in a meaningful acceleration of our pivotal trial enabling us in complete the study and generate significantly positive results more than 12 months ahead of the original plan. The Clintrex team were instrumental in helping us both advance our lead program and transform the future of our company.”."
- Greg Divis, Chief Executive Officer
Avadel Pharmaceuticals, plc
"Clintrex has been a remarkable help in forcing us to evaluate assumptions we have not thought in the past to challenge. It really makes this process more interesting and effective but also highlights the immense value Clintrex brings to NeuroCuresNY."
- Rajiv R. Ratan M.D., Ph.D.
Winifred Masterson Burke Professor of Neurology and Neuroscience
Weill Cornell Medicine Associate Dean (affiliate)
Weill Cornell Medicine Chief Executive Officer, Burke Neurological Institute
"Annexon is excited to see that ToxStrategies LLC and Clintrex Research LLC are now operating under one umbrella as part of BlueRidge Life Sciences (BRLS). Bringing experts in the non-clinical and clinical space under one umbrella offers clients unparalleled expertise in this space. ToxStrategies has developed and implemented the non-clinical strategies for Annexon since 2014 on all of our key programs. This includes multiple unique modalities and routes of administration in a variety of complement-mediated diseases. Likewise, Annexon has been working with Clintrex since 2018 on clinical development and regulatory strategy challenges for our lead programs, which overlap with those that ToxStrategies has supported. The level of expertise, dedication, out-of-the-box thinking, and solution-oriented approach on both teams has been first in class"
Doug Love, CEO
Annexon Biosciences
"We’ve had the pleasure of working with Clintrex, a BlueRidge Life Sciences Company, for over three years, and they’ve truly become invaluable thought partners in our journey to develop our Parkinson’s medication. Their expertise has been a game-changer in helping us map out a clear development pathway, from interpreting complex clinical and preclinical data to providing sharp insights that keep us on track. Beyond that, they’ve been hands-on with our Phase 2 and 3 studies—running the enrollment authorization committee, digging into anomalous data checks, and just being an all-around great addition to the team. When we’ve needed them, they’ve also stepped up with smart, reliable regulatory strategy support. BlueRidge Life Sciences doesn’t just deliver; they elevate everything we do and are a great partner who has been invested in our success."
Craig Thompson, CEO
Cerevance
"When Ovid’s vision expanded into brain diseases more broadly, we needed a deeply experienced partner to help us develop a creative clinical and regulatory strategy across our pipeline. I have worked with Clintrex for nearly ten years through several companies and immediately reached out to the Clintrex Managing Principal, Karl Kieburtz, MD to put into place a relationship with Clintrex. Over the past year, their level of experience, depth and breadth of clinical and regulatory knowledge, flexibility, dedication, innovative thinking, and solution-oriented approach has been remarkable and has contributed to rapid progression of our clinical programs. We have recently expanded this relationship to include experts at ToxStrategies, who are helping us shape our non-clinical studies for success. Clintrex and ToxStrategies have become a critical part of our teams. This group is not just smart and experienced, they are good, curious, open-minded people with high integrity."
Amanda Banks MD , Chief Development Officer
Ovid Therapeutics
"Since 2016 the BlueRidge Life Sciences Clintrex team has been supporting PhotoPharmics® with our clinical development program, regulatory strategy and securing investors for our FDA Breakthrough product, Celeste® specialized phototherapy for both motor and non-motor symptoms of Parkinson’s Disease and for future treatment in Huntington’s and Alzheimer’s. They have become an integral part of the PhotoPharmics team, whether it is solving complex clinical and regulatory challenges, explaining the science and clinical outcomes of our novel therapy to investors, or introducing us to clinical, scientific and industry contacts. The level of expertise, depth and breadth of clinical and regulatory knowledge, flexibility, dedication, out of the box thinking, and solution-oriented approach has been remarkable. With the support of the Clintrex team we look forward to successfully completing our FDA pivotal trial, receiving FDA and CE market authorizations and providing access to Celeste to improve the lives of patients throughout the world."
Kent Savage, CEO
PhotoPharmics