From the CNS Experts
CNS clinical trials are scientifically complex, with higher regulatory expectations than almost any other therapeutic area. Without deep therapeutic insight, strategic trial design, and early engagement with regulatory agencies, programs stall or fail.
Clinilabs’ clinical trial advisory and regulatory support services are your pathway to CNS approval.
Expert Advisory & Regulatory Support Services
Combining our unmatched CNS drug development expertise with our industry-leading knowledge of health care delivery, our advisory and regulatory support services help you launch your CNS therapy or device with the greatest potential for commercial success.
Advisory Services
Pulling from our senior advisors, external subject matter experts, and a diverse panel of professionals from industry, academia, and clinical medicine, we create advisory teams tailored to your development program that deliver actionable insights and solutions in protocol design and development, investigational new drug (IND) applications, translational medicine, and more.
Clinical Trial Regulatory Support
Clinilabs works with trusted partners worldwide to support clinical and regulatory activities in the North America, European Union, and emerging markets with:
- Regulatory guidance for the development of new chemical entities
- Execution of multinational clinical trials
- Evaluation of previously marketed products
- Multinational filings
- Regional applications for marketing drug products
We can also serve as your in-house regulatory team or offer advisory support on regulatory matters.
Clinilabs Is Your CNS CRO
What makes our advisory and regulatory support so valuable? Our deep, indication-level command of the central nervous system.
