Cetero Research Seminars Provide Insights on Designing Accelerated Proof-of-Concept Studies
“Pharmaceutical and biotechnology companies are very interested in the efficiencies that this approach can bring to their early-phase clinical studies. However, there are a number of complexities involved in developing these studies to successfully combine multiple protocols into a single study,” said Troy W. McCall, Ph.D., Chief Executive Officer of Cetero Research. “Cetero leadership and independent industry experts will share case studies and best practices.”
The scientific sessions will cover three aspects of Accelerated Proof-of-Concept (AcPOC) study design and conduct: protocol development, safety in first-in-human trials and patient recruitment strategies. The seminars will offer real-world advice on creating studies that strike a balance between the strict schedule to which accelerated studies must adhere and the built-in flexibility that these trials require for troubleshooting, efficiency and regulatory approval.
“With the accelerated approach, the protocol must be a living document that can be adjusted as you move through each component of the study. There needs to be flexibility in adapting to feedback from regulators and reactions from participants,” said Alan Copa, PharmD, President, Clinical Operations - Fargo for Cetero Research. “With the increasing demand for this type of study, it is important to discuss the best practices that will ensure the most efficient, robust study design possible.”
Each seminar will last two hours and include three presentations as well as a question and answer session. The series schedule is as follows:
• Thursday, April 28 — Bridgewater, NJ
• Wednesday, May 4 — Northbrook, IL
• Tuesday, May 10 — King of Prussia, PA
• Wednesday, May 11 — Cambridge, MA
• Tuesday, May 17 — La Jolla, CA
• Wednesday, May 18 — San Jose, CA
The Cetero sessions are complimentary, but pre-registration is required. For more information about the series or to register for a session, please email rsvp@cetero.com, visit http://www.cetero.com/acpocseminar/spring or call 877-7CETERO.
About Cetero Research
Cetero Research, the leading early-phase contract research organization (CRO), has conducted more than 20,000 clinical pharmacology studies, more than any other CRO. With facilities across North America, Cetero offers flexible, high-quality clinical development services in a range of therapeutic areas, including asthma and allergy, dermatology and diabetes, as well as bioanalytical services to support clinical, preclinical drug and biomarker analysis for small and large molecules. It uses innovative approaches, such as the Accelerated-Proof-of-Concept study design, to provide key decision-making data earlier in the development process. A pioneer in the pharmaceutical and biotechnology space, Cetero prioritizes ensuring the safety of its patient and normal healthy study participants, reporting high-quality, reliable data and providing on-time results. For more information, visit www.cetero.com or call 877.7CETERO.
For more information, please contact:
April Johnson
Vice President, Business Relationship Management
Cetero Research
Direct Line: 919-468-4214
Email: april.johnson@cetero.com