End-to-End Program Management

Capabilities and Experience:

Program/Project Management is a core component of our functional sourcing services, which allows us to deliver optimal results for our clients. Our project managers have more than just project management expertise: They understand how to manage a clinical trial with appropriate design (e.g., Adaptive), run the project at a high level with respect to the functional areas in a project, use our delivery methods and tools to accelerate the clinical trial with the highest probability of success, and be innovative in their approach.

We take a structured approach to creating an effective and efficient project flow Program initiatives are divided into a set of smaller, manageable projects.

• Projects are then further simplified into stages, milestones and deliverables
• Following high level planning, the initial program assumptions are reviewed and updated
• The teams function as a collective unit with the same goals via coordination of these program subcomponents

Our Project Management Office (PMO) approach:

We take a multilayered Project Management Office approach, with groups working both towards specialized goals and general goals in a clinical trial. Through role specialization within a collective project team, Advanced Clinical can coordinate and communicate to efficiently accelerate clinical trials and create value:

Results:
We have had significant results across Program/Project Management:

• Led program/project management for 220+ clinical trials
• Managed 100+ large consulting programs
• Designed and established Program Management Offices (PMO) for programs from $300K-$500MM
• Created codified templates and tools for running projects/programs
• Constructed quality project teams across industries.

Deliverables:
From a project management perspective, Advanced Clinical brings a suite of quality deliverables. These proven tools and techniques ensure coordination across work streams and organizations. Our seasoned project managers use the following to drive the project through proactive facilitation and subject matter expertise:

• Project Plan Templates
• Decision Identification and Process Guidelines
• Status Updates
• Issue/Action Item Registers
• Communication Plans
• Team Calendar Management
• Quality Control Process
• Risk Management Plans
• Communication Plans
• Resource Management Plans

Differentiators:
Advanced Clinical’s Clinical Project Management skills go beyond “typical” project management, as our competencies encompass both general project and clinical trial management areas:

General Project Management:

• Project and Resource Planning
  
  • Understand goals; create and maintain project timelines, dependencies and deliverables
  • Plan and coordinate resources and handoffs
  • Plan personnel requirements by skills set
• Decision Management: Identify key decisions and support management decision making between alternatives
• Resource Management:
  • Perform team integration, ramping, retention management, coach and rewards provisioning
  • Manage permanent and contingent staff
• Change Management: Manage changes to the original project plan to support goals. Provide a systematic method for evaluating, approving and managing changes to technical, cost and schedule baselines
• Quality, Risk and Issue Management:
  
  • Review and audit project activities and deliverables to ensure that the project deliverables will meet operation, industry and customer quality requirements
  • Identify risks, assess risks (e.g., impact, probability, etc.); identify mitigation activities for risks (Risk Management)
• Benefits Realization/Financial Management: Budget model illustrating fiscal benefit to be delivered and cost structure (labor, travel, etc.) to reach goals
• Communication Management: Identify stakeholders; create communication plan for each stakeholder group; construct and deliver
• Knowledge Management:
  • Identify, track and control documents required during project onboarding, training and orientation
  • Capture knowledge during project and create knowledge transfer plans to ensure continuous learning and identify lessons learned
• Service Management: Procure material, equipment and subcontracted resources to support project and manage third party services against contracts/milestones

Clinical Trial Management:

• Clinical Trial Management in Trial Specifics:
  
  • Decision management
  • Therapeutic area expertise
  • Phase-specific information
• Clinical Technical and Functional Expertise:
  
  • Knowledge of all functional components of Phase II trials and critical interdependencies across functions
  • Knowledge of how all key functional areas work
• Clinical Innovation: Knowledge of new “accelerators” for clinical trials, including Adaptive trials, Electronic Data Capture (EDC), etc.
• Clinical Trial Market Dynamics: Knowledge of critical steps necessary to ensure successful outcomes (e.g., price point for drug, differentiation, etc.)