True Project Management

AC has a comprehensive Program Management Framework for managing a team across locations, guided by our Program Management Office approach. The key components of our framework include:

• Project Planning
  
  • Project Plan, Timeline and Dependencies
  • Resource Supply/Demand Management (Collaborative Planning and Forecasting)
  • Goals, Expectation and Change Management
  • Risk and Issue Management
• Resource Management
  
  • Retention Management
  • Performance, Rewards Management
  • Contingent Staff Management
  • Team Integration
• Financial Management
  
  • Cost and Benefit Management
  • Invoicing Management
  • Contract and Payment Term Management
• Quality Management
  
  • Quality Assurance
  • Quality Control
  • Continuous Improvement
• Knowledge Management
  
  • Project Orientation, Onboarding
  • Knowledge Capture and Transfer
  • Manage Processes, Policies, Procedures, Standards, SOPs
  • Training, Continuous Learning
• Service Management
  
  • Metrics/KPI Management
  • Service Agreement Management
  • Technology Management
  • Stakeholder Management
• Subcontractor Management
  
  • Sub-Contractor Selection, Contract
  • Performance Management
  • Align Tools, Processes
• Cross Location Management
  
  • Collaboration Management
  • Communication/Engagement
  • Team Member Orientation
  • Handoffs

Program planning seeks to guide all the elements below it and therefore, sits at the top of the framework. Cross-Location Management is a foundational suite of processes and tools across all elements of the program, which forms the bottom of the framework.

Project Planning:

Project Plan and Schedule:
A project plan will be created in MS Project format or a tool that our client uses. The plan will be divided into phases and have the following design for each phase:

a) Phase name and title
b) Timeframe and duration
c) Objectives
d) Task name, owner, original date, revised date, and status (R/Y/G)
e) Inputs
f) Outputs (deliverables)
g) Project management activities
h) Key dependencies

Project Tracking-
Project tracking will be in the form of work plan updates, a status report, and tracking against plan:

• The project plan will be updated real time during the week
• Dates/Tasks will be re-forecasted as agreed to by both the client and AC
• Issues will be noted in the status report with an associated action plan

• Tracking against plan will come in the form of illustrating which tasks are complete in our Project Plan and Schedule and in which tasks we are behind

Weekly Plans-
The AC project team will issue a day-by-day schedule of activities to ensure that the project team, the sponsor, and the partners are aware of meetings, events, interviews, workshops, and other obligations. The weekly plan will include key issues that should be addressed (and closed) during the week.

Status Reports-
Each Friday the AC team will prepare a status report in our format. This status report tracks the project’s success against seven key criteria and the current issues that need to be addressed to keep moving. Each issue will have an associated action plan. This report will be forwarded to the project sponsor, the project team, and the partners. The project manager will also forward an updated copy of the work plan, the tracking statistics, and the “week-at-glance” of the following week’s activities.

Resource Supply/Demand Management:
We match client resource needs to talent supply within Advanced Clinical and/or sub-contractors. AC has a proven Supply/Demand Management Methodology that projects resource requirements and matches them to our strong consulting team as well as a database with 200,000+ consultants.

Supply and Demand Management

Goals, Expectations and Change Management:
AC seeks to understand goals and expectations as well as manage change on a continuous basis. To manage the changes that occur, we have a strong change management methodology as outlined below:

• Identify and evaluate changes:
  • TCMs identify, evaluate, and document (change request form) requirements for changes/additions
  • Changes/additions are evaluated in terms of time, resource, and cost and risk impact
• Changes tracking:
  • Requests are maintained in change request log: a central directory where changes are coded, described, dated and given a status
  • When a specific task has a pending change request, the change request number may be reported on the project plan for monitoring
• Decision on changes:
  • Project Managers are responsible for approving changes together with the appropriate Amgen stakeholder:
    • If they have a limited impact on development time
    • If they do not impact the scope of the project

Risk and Issue Management:
AC seeks to prevent issues that can delay a trial. Therefore, we have created a rigorous risk management process. In addition, we have created a strong issue management process to quickly address barriers that are impacting project performance.

Risk Management

Resource Management:

Retention Management:
One of the most significant levers in creating a high performing team is selecting and retaining talent. We have our sophisticated model for selecting team members.

Resource Management Model

Performance, Rewards Management:
AC has a proprietary Performance Management Framework for consultants based on: capability/maturity objectives, client management and delivery, thought leadership and knowledge management. Each level of the project team has different capability objectives. Managers, for example, have additional objectives such as: fulfillment of engagement commitments resulting in satisfied clients, business case delivery (cost/benefit) and healthy teams.

AC also has an "experience model" for our clients, sub-contractors, employees and consultants. The elements under our Performance Management Framework are aligned to the positive experience that we desire for each of these stakeholders.

Team Integration:
AC has found that the team integration approach is one of the most important elements to master at the outset of the project. Team integration helps the team to work harmoniously together if done properly and ensures a well-functioning, high performance team. Our model focuses on the "soft side" of team integration as well as the "hard side" of team integration.

Team Integration

Financial Management:

Cost and Benefit Management:
At the onset of every project, we seek to understand the client’s budget, and we develop a model that illustrates the fiscal benefit we will deliver. The cost structure includes labor, travel, and other similar elements. The benefit structure includes items such as retention rate, onboarding timelines, productivity, time to recruit, etc. We develop a financial model that illustrates both the cost and the benefit we seek to achieve for clients.

Business Case Modeling

Quality Management:

Quality control consists of operational techniques and activities undertaken to verify that the quality requirements for the trial have been fulfilled.

Quality Assurance: A quality assurance plan will be created that describes the frequency of audits and the processes to be audited. The purpose of the audits will be to ensure that SOPs and other internal processes are followed. An internal audit will be performed at least annually to ensure that SOPs meet regulatory requirements and follow best practices.

Quality Control: A quality control plan will be created for each project that lists each task and the level of quality control required for each task. All statistical documents, such as SAPs and derived dataset specifications, will undergo an independent statistical review before they are finalized. Regulatory documents, such as clinical study reports, will undergo two quality control checks prior to delivery.

Knowledge Management:

Project Orientation, Onboarding and Ramping:
AC has a highly structured project orientation, onboarding, and ramp up approach for the members of the team. Our approach accelerates our ability to get the team to peak performance quickly. AC employs a variety of digital, Web-based tools to ensure teams get the appropriate training, virtually.

Ramping, Onboarding and Selection Process 

Training and Continuous Learning:
As part of our team’s Performance Management, we require that our teams receive ongoing training. In addition, Advanced Clinical is devoted to continuous learning as an improvement model that constantly accelerates scheduling, avoids risk, improves efficiency and optimizes the entire project.

Continuous Learning

Service Management:

AC's Service Management approach seeks to manage every aspect, both tangible and intangible, of the solution that the client receives. Identification and management of the appropriate KPIs is at the heart of what drives the best performance. AC has identified the common performance management KPIs, but we tailor these for every engagement to align ultimately with the business principles, management principles and data principles (we can provide these upon your request).

Metrics/KPI Management:
While AC has many approaches for Key Performance Indicator identification and management, a "first principles" approach is the most important ingredient in KPI management. The first principles AC uses are outlined below:

• Create a balanced view of KPIs: This includes: financial, service level, innovation, business process efficiency and portfolio prioritization
• Ensure KPIs are relevant and transparent
• Are owned jointly by the client and AC team
• Align KPIs to management objectives
• Reinforce continuous improvement

Subcontractor Management:

AC has learned through extensive project engagements and consulting audits that sub-contractor management is an essential scenario for our clients. We have a comprehensive sub-contractor management toolkit. As part of this toolkit, there are two elements that have the most impact on the overall sub-contractor performance.

Performance Management:
Subcontractors are measured differently based on what type of skill set they provide, the role they play on the project as well as the degree to which AC partners with them. The key is to align the client’s performance requirements with sub-contractor performance metrics. Therefore, metrics change based on the supplier. Generally, however, the following categories of metrics are managed:

• Invoice terms
• Payment terms
• Delivery terms
• Quality metrics
• Corrective action policies
• Additional measures specifically noted in the contract

In addition to managing metrics, it is important to follow a rigorous performance management method for sub-contractors. Every sub-contractor will have a scorecard, regular review meetings against this scorecard and use of standard corrective measures when necessary to ensure clients receive the best possible performance from the team.

Align Tools, Processes:
There are soft aspects of making sub-contractors part of the team, but there are also "hard" team management aspects. AC uses the "soft side" of integration approach to ensure sub-contractors feel they are part of a bigger team. From a "hard" team management standpoint, everyone needs to use the same tools and processes. Therefore, at the beginning of any work with a sub-contractor, they receive training and mentorship of our clients’ and AC's tools and processes. AC employs a training boot camp model to ensure all are aligned and understand the appropriate tools and training.

Cross-location Management:

AC has learned through extensive project engagements and consulting audits that cross-location management is a crucial area for our clients. As a result, AC has developed a method for cross-location management.

Collaboration Management:
The heart of making cross-location teams work seamlessly is in creating a team where every person feels they are a valuable contributor. AC has developed a suite of processes and tools to ensure that collaboration happens across the team and each member of the team is considered an invaluable asset. Within the AC process is a clear channel for collaboration across the team. In addition, AC has a suite of tools that allows for instant collaboration. Tools include instant messaging, an internal, secure "mash-up" for messaging across the team, a shared project and knowledge management workbench, etc.

The key with the collaboration processes and tools is to create a common understanding of what processes and tools will be used, what the expectation is in using these tools and how to ensure that all members of the team are using them when needed.

The result of collaboration includes elements such as:

• Joint process improvement opportunity identification
• Joint process improvement plans

Communication/Engagement:
AC believes in investing in formal communication as well as ensuring engagement with teams. Communication is "one-way," and engagement allows for "two-way" dialogue.

The objective of communication and engagement is to have a tool for managing stakeholder’s attitudes and building and sustaining commitment in a project by:

• Providing consistent messages to all stakeholders with standardized words
• Increasing transparency and transferring the needs and benefits of the project
• Providing relevant and current information to reduce anxiety
• Minimizing the spread of miscommunication and creating two-way feedback mechanisms
• Building commitment and readiness to perform by encouraging trust and confidence in the organization during a period of disruption and uncertainty

Team Member Orientation:
From a "soft-side" standpoint, many elements come into play when a team is working virtually. One of the most important elements of a virtual team working well together is a sense of mutual trust. To build mutual trust, it is important for each team member to understand the capabilities of the other team members. As a result, we make each team member's capabilities clear from a formal introduction to the team, but, in addition, post credentials on our internal shared project portal.

Given that AC wants the best possible experience for our clients, from a "hard" orientation standpoint, for each project we work on, AC develops internal orientation materials to ensure our teams are properly trained and have a common approach to the client. The purpose of this orientation is to align our team on the client experience AC requires. Elements like problem solving skills, escalation approach and stakeholder management are in this material.

Team Integration

Handoffs:
In a project plan, the dependencies are clearly outlined. However, there are typically unclear expectations as to what the dependencies mean. As a result, AC outlines specific handoff requirements in addition to outlining dependencies. The handoff requirements include templates of what the deliverable should look like, when specifically the draft should be completed, to whom the versions should be sent, who needs to review and approve deliverables, etc. The AC handoff approach makes it abundantly clear how a deliverable gets to an "approved" state. AC's handoff approach helps to set each team member up for success.