Clinical Trial Management
We understand the critical issues for every study while focusing on meeting the accelerated timelines needed in today’s fast-paced drug development environment.
We recognize that our clients expect quality data utilizing the most current technologies available.
We have a clear understanding of the issues, environments, and challenges that are currently driving the industry and, with that in mind, we have structured our company to provide excellent execution of multi-therapeutic Phase I-III clinical trials.
Our Therapeutic and Research Expertise are:
- Abuse Liability
- Sleep Medicine
- Phase I
- Phase II-III
- Thorough QTc Studies
- CSF Extraction
- Dose-Ranging Studies- SAD, MTD
- Bioequivalence, Bioavailability
- Pharmacokinetic & Pharmacodynamic
Clinical Trial Management (CTM) Services include:
- Project Management
- Clinical Drug Development and Regulatory Affairs
- Study Design and Protocol Development
- Site Recruitment and Management
- Recruitment & Retention Strategies
- Medical Monitoring & DSMB
- Data Management
- Medical Writing