Join the Clinical Research Strategies team of talented and accomplished professionals serving the Life Sciences industry.
“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
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.
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.
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.
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.
CONTACT US TODAY!
THE LATEST FROM CLINICAL RESEARCH STRATEGIES
CRS Welcomes Sidney Lane as Our Newest Intern!
Clinical Research Strategies welcomes Sidney Lane as our new intern for the next 16 weeks beginning May 1, 2023. Sidney is currently a PhD Candidate at the University of Pittsburgh School of Medicine. Her thesis work focuses on the role of extracellular vesicles in mediating bacterial-immune cell interactions in the respiratory tract. Sidney’s interests are in translational work that can make an impact, and in clinical trial management.
CRS is collaborating with the University of Pittsburgh to provide interns with experience in clinical and regulatory affairs, medical writing, consulting, and business development. Sidney will work with the CRS team to gain an understanding of clinical trials and the different steps involved in bringing new technologies to a place of impact. Please join us as we welcome Sidney to our team!
EVENTS & MEDIA
The Inaugural Pittsburgh Industrial Statisticians Association (PISA) 2023 Conference
May 15, 2023
Clinical Research Strategies assisted in the organization of an industry-focused statistics conference in the Pittsburgh region. For the 2023 event, our very own Haley Fuller, PhD, presented in the Biostatistics in Healthcare Session. Pictured above (l-r) are CRS’ Julie Cramer, Haley Fuller, Sidney Lane, Alyssa Harris, and Parul Nisha.
A Case Study on Dose Ranging: From MADness to Method
David Anderson , Clinical Research Associate, Clinical Research Strategies
CRS IN THE NEWS
CRS Team Members are Helping to Promote Careers, Leadership, and Entrepreneurship for All Women in the Life Sciences
The Women in BIO (WIB)-Pittsburgh chapter is working to support recognized and emerging women leaders in the biosciences industry of Western Pennsylvania, Eastern Ohio, and West Virginia. CRS’ Parul Nisha, Chapter Vice Chair, will be supporting new Chair, Joie Marhefka. Vonya Eisinger has joined the team as Communications Co-Vice Chair, and Alyssa Harris has joined as YWIB Communications Chair.