Through Azelix’s strong partnerships with dedicated and specialized Phase 1 research centers throughout the U.S., we are able to provide our expertise in the management and execution of early phase clinical trials. This includes regulatory and medical writing, clinical data management, bioanalytical, statistical expertise in PK/PD analyses, and protocol design. Our team of early phase experts will work closely with your team to develop a study strategy, including adaptive protocol designs, that will help move your product to proof-of-concept quickly.

Azelix’s early phase services include:

  • Project Management
  • Medical Monitoring
  • Pharmacovigilance and Product Safety
  • Data Management
  • Biostatistics and Statistical Programming
  • Regulatory
  • Site Management
  • Clinical Monitoring
  • Medical writing (protocol and CSR)