Duration: 16 Months
Project Overview:
Eli Lilly recognized the need for improved control over their clinical trial workflow, which consists of six distinct steps: Concept, Proposal, Protocol, Study Readiness, Active Trial, and Trial Submission to FDA. To achieve successful clinical trials, coordination among three user groups – Admins, [user group name], and [user group name] – was essential. However, the existing standards systems based on the Clinical Data Interchange Standards Consortium (CDISC) and the XML document interchange using Electronic Data Capture (EDC) systems, along with CDISC’s Operational Data Store, required better integration and management of project management tasks.
The Product:
During my involvement in the team, we developed a product based on Microsoft SharePoint MOSS and custom-built microservices. This product effectively handled project management tasks throughout an active trial.
The Problem:
The misalignment between project management and the trial’s state often led to issues during the FDA submission, resulting in delays and extended preparation time.
The Goal:
Our goal was to create a system that remained synchronized with the Operational Data Store (ODS) and project management. Specifically, the project management objective was to:
1. Develop an idea: Assessing the necessity of the project and identifying key decision-makers.
2. Make a plan: Outlining the required work, including prioritization, budget, schedule, and resource allocation.
3. Distribute tasks: Informing all teams about their responsibilities and deadlines.
4. Project tracking: Comparing the current project status and progress against the original plan and making necessary adjustments.
5. Evaluate: Highlighting project success and learnings for future endeavors.
My Role & Responsibility:
In this project, my responsibility involved configuring and preparing three environments of the MOSS system: development, staging, and production. Additionally, I extensively contributed to the coding for integrating microservices into custom web parts.
Pain Point:
Clinical trials entail substantial financial investments, and any delays or failed submissions can result in significant expenses. It became imperative for Lilly to ensure that trial management and project management were synchronized and efficient. The loss of time and money was no longer tolerable.
Solution:
Our solution revolved around enhancing the role of the clinical trial project manager, as they play a pivotal role in trial success. The solution encompassed vendor selection, timeline and budget oversight, IRB submission management, report generation, and meeting planning. By empowering project managers to evaluate and choose external vendors, maintain accountability in terms of time and money, manage IRB submissions, generate reports, and organize stakeholder meetings, we addressed these critical areas effectively.
The Impact & Lessons Learned:
Throughout this project, we realized the importance of examining the necessity of a function and identifying key decision-makers as fundamental to developing software solutions for a company of Eli Lilly’s scale. Furthermore, we learned that missed steps in the planning process can significantly impact the project, necessitating a reevaluation of required work, including prioritization, budget, schedule, and resource allocation. Effective communication channels and proactive stakeholder management were vital in mitigating these challenges and ensuring well-researched and feasible decision-making.
By implementing these improvements, Eli Lilly experienced enhanced control over their clinical trial workflow, minimizing delays and inefficiencies. The successful integration of project management and trial management resulted in more streamlined processes and reduced costs, demonstrating the significance of efficient project management in the pharmaceutical industry.
