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Execution Model for Clinical Data Management IT Support

Execution Model for Clinical Data Management IT Support

HCL was engaged by a top 10 global pharmaceutical to define an Organizational and Delivery Model for the role of Global Clinical Trial IT Trial Support Specialist. This engagement required business process analytics and technology assessments delivered via industry best practices.

Business Objective:

  1. The client was looking to reorganize the IT support staff responsible for clinical trials management applications, aligning it with the business needs. HCL was to provide the following:
    1. a RACI chart with supporting documentation for the new role
    2. Updated Process workflows
    3. Governance and Organizational Models for the new role
  2. The client was looking to build a set of supporting tools to allow the newly engineered position to be successful from day one

Solution Highlights/Engagement Highlights

  1. HCL surveyed the staff and documentation stores and created an Information Map, detailing all sources of Information used for reporting and the supporting metadata. This included who published the data, the frequency of publication and highlighted redundancies and information gaps
  2. HCL provided and analysis of operations, including detailed finding on workflow management, business gaps, information escalation and identified problem areas
  3. HCL provided a detailed recommendation, mapping against ITIL standards for Reporting, Governance, Demand Management, Problem Management and Root Cause Analysis
  4. HCL's proposed Operational Model provided the first "Enterprise" or "Portfolio" view of the role, removing it from the Study or Project centric view used historically
  5. An IT Services Catalog was generated supporting the role and its place in the larger IT organization. This initial catalog covered all phases of the study lifecycle
  6. Using the Information Map generated as a part of the engagement, HCL created a Reports Catalog covering Operations, Business Metrics and Help Desk Support activities. This catalog also highlighted areas that needed additional coverage in reporting
  7. Through the identification and mapping of all relevant data sources, HCL was able to provide a view across all relevant information areas, establishing a framework for the data source mappings used to create the Trials Portfolio Dashboard
  8. HCL's macro programming expertise paired with business analytics led to an effort to streamline and normalize metrics collection and reporting. Manual labor was replaced with macros, resulting in significant reductions in metrics preparation cycle time and errors
  9. HCL wrote an application that created an Executive Dashboard for Study metrics. This dashboard provided the first portfolio view of the study data, across IT operations, business data mapping and server metrics. The dashboard presented by an aggregated view of the data as well as study specific detailed views. This dashboard provided a first time normalized view of operations across the portfolio
  10. HCL was able to bring the Dashboard application through an accelerated SDLC from project planning to Proof of Concept Deployment in 8 weeks

Benefits Delivered

  1. The dashboard provided the client with its first portfolio view of study metrics, allowing them to move from a reactive operations model to a proactive model. This also allowed them to readily view trends over time, further providing them with the ability to be proactive
  2. The realignment of the trials support role with business needs increased the value and efficacy of the staff in the supporting roles. By leveraging the new processes and taking the support role out of daily operations and into trial health monitoring and trends analysis, the staff in this role were able to act on issues before they impacted operations
  3. The creation of Excel macros in the metrics spreadsheets reduced the cycle time of reporting preparation by several hours per week, in addition to increasing Quality by removing copy and paste errors


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