Re-alignment of clinical study aggregation
and reporting tool
The Challenge
A large pharmaceutical company (F500) was struggling with a multitude of challenges within its clinical data management and reporting systems. This system is utilized for interacting with and managing data exchange with external groups including clinical research organizations (CROs) and regulatory bodies, and internal groups including R&D and leadership at various levels. The client’s business model for conducting clinical trial work was changing, requiring internal tools and applications to be able to receive drug protocol data from various alliance partners. As a result of changes to data sources, connectivity and application integrations between data source groups and consuming groups needed to be re-aligned and updated.
Approach
The client required external advisory to perform a gap analysis and establish new business and functional requirements on the basis of the client’s evolving needs and facilitate more efficient and effective data retrieval and usability for all stakeholders involved:
- Leadership: Need to enable greater visibility into clinical trials, adverse events, reporting, status to inform future direction, budgeting
- CROs: Require standardized and efficient interface for data exchange with client systems
- R&D: Standardization needed in data gathering/ exchange across multiple external stakeholders, with ability to query and update data and reporting standards as needed
- Regulatory bodies: Report generation must be efficient and comprehensive, including aggregation for overviews
Outcomes
Collaborated with client technical teams and business leads of stakeholder groups to assess gaps in functionality and standardization in clinical data aggregate layer. Process determinations informed business process documentation (Visio) and business/functional requirements. Challenges addressed include:
- Lack of query functionality that aligns with the Aggregate Deliverable reporting period
- Clinical trial databases may not be updated with the most recent and relevant information when the aggregate report is due
- Some clinical trial data may not be available to determine if the clinical trial is applicable for reporting from a systematic perspective
- Manual review required to guarantee accuracy of the data
Prioritized core functionality addressed included:
- Retrieval if all clinical trials for a specific product of interest
- Based on deliverable type and reporting period of interest, systematic determination of a draft listing of clinical trials that qualify for reporting, based on available data
- Ability for specified stakeholders to save manual updates of clinical trials qualification for reporting, if differing from the automated system determination