Accelsiors approaches Project Management in a distinctive way that ensures effective collaboration, communication and execution. We standardise best practices across clinical management, compliance and data capture across all studies.

We begin with the study kick-off meeting to ensure that effective plans are in place and that Investigators are adequately trained and prepared for a rapid study launch. The Project Manager is the lead of the study and responsible for every facet of its success. To achieve this, they must possess a collaborative spirit while leading by example.

Unexpected difficulties may arise even in the most thoroughly planned trial. To prepare to those events that we cannot prevent Accelsiors introduced The Quality Heath-Check process, that is designed to ensure pre-defined and agreed acceptable levels of quality for deliverables and processes supporting a study are in place and metrics reviewed periodically to ensure all is “on-track” to deliver a high quality study.

THE STUDY QUALITY HEALTH-CHECK PROCESS:

• Establishes Quality expectations for the study
• Provides an overall and customized quality approach for the deliverables and services involved in the study
• Defines Project team quality management roles and responsibilities throughout the study
• Establishes and periodically reviews a balanced-scorecard of key performance indicators with thresholds for Quality Improvement/contingency plan implementation and/or escalation

WE ARE CONSCIOUS OF THE IMPORTANCE OF:

• Clear and detailed planning and maintenance of project plans
• Proactive budget planning and control
• Resource planning throughout the conduct of the study
• Comprehensive risk planning and proactive management
• Clear decision making based on project performance metrics
• Highly effective cross-functional communication.

PROJECT MANAGEMENT SERVICES:

• Project planning
• Risk planning and management
• Communication planning
• Budget control
• Project performance management and oversight

OUR ASSIGNED PROJECT MANAGER WILL:

• Serve as the primary point of contact for the Customer and internal study team
• Provide leadership and direction to the project team, effectively communicating specifications for time, quality and cost
• Utilise Accelsiors systems and processes to ensure efficiency and accuracy throughout the study
• Ensure effective risk management throughout the study, and
• Maintain a flexible, “can do” approach to address issues innovatively and efficiently

Learn more about our comprehensive clinical development services

Accelsiors offers a complete range of expertise in support of your specific needs: Scientific, analytical and regulatory complemented by global resources, state-of-the-art technologies and project management methodology for the most effective execution of your development program across all phases of clinical drug development.

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