Azelix’s team of experts are adept at managing all aspects of Phase II-III clinical trials. Team members are assigned to studies based on therapeutic experience and will be fully aligned with the disease of interest. The project manager plays a crucial role in guiding the success of research studies particularly with large enrolling multi-site Phase II-III studies. Serving as a central point of contact with clients and our clinical project teams, strong and effective communication and organization skills are critical attributes that all of our project managers possess. Combined with our comprehensive approach to project management principles and our well-defined processes, our project managers will bring your clinical trial to success.

We believe in fostering strong investigator site relationships. By selecting the right investigator sites, it enables us to achieve enrollment targets within contracted budget and timelines. We use comprehensive study-specific questionnaires, feasibility assessments, and expert evaluations of potential sites to ensure a high probability of success for each study.

All members of our clinical monitoring team are experienced and highly trained industry professionals. Our first priority when it comes to team member assignments is ensuring that the CRAs assigned to your project are therapeutically aligned. As much as possible, we utilize regionally based CRAs who are located within close proximity to the selected investigator sites. This allows for CRAs to be more intimately involved with their sites while also helping to minimize travel expenses. With Phase II-III clinical trials, the ability to handle large volumes of incoming data is crucial. Our data management and biometrics teams have decades of experience having handled thousands of SDTM and ADaM datasets. Through the implementation of risk mitigation strategies and data visualization tools, our data management experts are keen to quickly spot data trends and issues ensuring data quality and subject safety. Azelix’s Phase II-III services include:

  • Project Management including Vendor Management
  • Site Management
    • Feasibility
    • Site Identification and Selection
    • Site Qualification
    • Negotiation and Management of Investigator Grants
    • Regulatory Document Management
    • IRB/EC Submission
    • Site Initiation
  • Investigator Meeting Preparation
  • Clinical Monitoring
  • Central Monitoring
  • Trial Master File Management
  • Medical Monitoring
  • Pharmacovigilance and Product Safety
  • Data Management
  • Biostatistics and Statistical Programming
  • Regulatory
  • Medical Writing (protocol and CSR)