Clinical Trials and Relationship Management
Description of Project
The client conducts a large number of clinical trials with study teams and investigators based all around the globe. The project is set to deliver a CRM application for managing information relating to those clinical trials activities in real-time, facilitating communications both internally and externally, and improving reporting capabilities. The new application will allow money to be saved through streamlining existing processes and retiring multiple legacy systems.
The client needed to manage numerous stakeholder groups, both internal across the business divisions and with external partners. The client follows a specific change management methodology, which places special focus on managing relationships with sponsors within each stakeholder group. Having had experience of applying this methodology on another project for the client, the project leadership were looking to Chaucer to provide expertise in implementing this change management methodology in a pragmatic and effective way.
Chaucer’s Scope
The project leadership knew that the project would accrue the best possible benefits if it created a collaborative and self-sustaining user community that is committed to the change. Therefore the team looked to provide ways for the users to get involved and stay involved in the development and enhancement of the system beyond the initial release.
The change management team contributed to this goal by identifying liaisons within each stakeholder group, on-boarding them to the project team and then delegating responsibility to them for cascading project communications to their respective stakeholder group. This meant that 2-way communication pathways were opened up with a globally dispersed and diverse stakeholder community, but with minimal travel expenses.
Chaucer also took every opportunity to introduce its best practice project management techniques, including initiating regular reports across the business work streams, managing the change management project plan, and contributing to the implementation plan and cutover strategy.
The Chaucer consultants worked closely with the other project work streams, high-lighting the interdependencies between the work streams and emphasizing the need to manage those interdependencies and associated risks.
Key Features of assignment
Business Objective: To create a streamlined & simplified set of efficient trial and relationship management core processes and tools, with the ability to more easily adapt to continuously evolving internal and external environment & challenges.
Project scope: all groups involved in clinical trials at platform sites, in Country Offices globally, and third party investigators. It encompasses all therapeutic areas, from study start up through closure.
Dependencies: There are a significant number of business process improvement initiatives running in parallel with the project; there are interfaces at the systems level which need to be managed.
Organisation: The project was governed by the client's internal project standards.
Business Change Management: Chaucer was invited to support the Business Change Management (BCM)activity, reporting to the Global Implementation Manager and the Program Management Office:
- BCM Strategy development: gather data relating to stakeholders (such as legacy systems, users, study status, communication channels, and sponsors) to support and define BCM strategy. Providing input to cutover strategy and implementation plans
- BCM Strategy implementation: define and implement the process for on-boarding stakeholder liaisons for each stakeholder group, supporting the creation of communication materials. Conduct an assessment of line management engagement with the project
- Scoping and Planning: Establishment of plans, deliverables and milestones – tracking process for delivery assurance
- Issues & Risks: Manage and run the risk process for the BCM element of the project. Work with the other project workstreams to high-light and manage the interdependencies and associated risks
- Project Team Meetings: preparations for leadership team and BCM meetings
- Reporting Process: Information gathering and development of reports for regular meetings as well as continual monitoring and development for any new requirements as the project moved through its phases
Benefits
Over six months, Chaucer has substantially increased the chances of successful implementation, by creating a firm foundation for the change management activity. It has ensured that the stakeholder groups have been identified and that the people are in place to communicate with line management and users of the new application. In addition, the work to create visibility of interdependencies and to manage the associated risks will have lasting benefits for the team as they move into the implementation phase.
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