Clinical Project Management

Averion provides full project management support for global Phase I through IV trials in all major therapeutic indications.  Averion assigns a Clinical Project Manager (CPM) to each study to communicate and manage all study activities and act as the primary liaison to the Sponsor.  At the onset of a trial, the CPM works closely with the client to understand their goals, sensitivities and expectations.  In addition, they identify the client’s target audience for the study results  (be it an FDA/EMEA, clinical or marketing audience) and research all aspects of the specific product, all of which will factor into the overall project planning.  They communicate the client’s needs to the entire project team and plan the trial design, execution strategy and set project team goals and timelines to align with the client's expectations.

Averion additionally offers program management support for overseeing large programs or accounts and ensuring consistency across the individual trials by aligning them with the needs of the overall program. 

Clinical Project Management Activities 

• Assure compliance with GCP and other regulations and guidelines.
• Oversee study planning, implementation and close out throughout life cycle of study.
• Facilitate study activities and the provision of key deliverables.
• Design and maintain timelines in alignment with key study milestones.
• Establish lines and flow of communication with internal team members, the sponsor, and outside vendors.
• Provide ongoing communication with team members and partners of study progress, procedures and policies.
• Establish agendas, organize and facilitates in person or online team meetings and communication (internal & external).
• Monitor study budgets and associated financial procedures and manages variances.