Clinical Stage Biotech AIM Assessment

A biotechnology company focusing on clinical stage pharmaceuticals was embarking on a journey to mature how it handles and manages information.  Their goal is to provide access to the appropriate information to the appropriate stakeholders in a secure and readily accessible manner, however based on recent events there was increased urgency to mature the Information Asset Management (IAM) process to address the following challenges:

  • Ensure ability to prove artifact lineage and that documents are compliant, consistent, and accurate for FDA submissions.
  • Regulatory changes such as General Data Protection Regulation (GDPR) creating new requirements that are difficult to meet within the allowable deadlines.
  • Valid users have difficulty finding critical information and are unable to easily determine which document is the gold copy.
  • Need to have more control to increase loss prevention, provide early detection and initiate remediation.
Challenges

This company was experiencing significant growth in its information assets across a multitude of applications, both on-premises as well as in the cloud, compounding the challenges highlighted above.  These large datasets had little-to-no management process for loss prevention, archiving or deletion, and data volumes were projected to double in the next 18-24 months.

Results

The Information Asset Management initiative was part of a broader Information Management program. This initiative helped provide a view into information assets, allowing the company to identify and secure its vital information assets.

During this engagement, the Triverus team worked with four departments – Research and Development, Clinical, Technical Operations, and G&A – to gather information and document key findings.  This analysis focused on the following four areas:

  1. Data Integrity, Lineage, and Compliance
  2. Data Security and Access
  3. Data Infrastructure and Integration
  4. Business Performance and Productivity

Based on analysis across these key areas, Triverus developed an actionable roadmap outlining recommendations and next steps to better protect and utilize data across the organization.

How We Helped

Triverus worked with this organization to develop a pragmatic, long-term roadmap to establish a sustainable IAM program.  This plan factored in the organization’s current state, tolerance for risk, resource availability and overall urgency.  This plan also factored in their Information Technology group’s go-forward system administration and management footprint.  

Tags
Life Sciences
Data Liability Protection
Technologies
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