Data Liability Protection for a Biotechnology Company

A biotechnology company specializing in genetic diseases embarked on a journey to mature how it handles and manages information with the goal of ensuring that the right information is available to the right people at the right time in an efficient, secure and compliant manner. The company anticipated significant growth in business capabilities and the addition of new systems to support those capabilities, all of which will generate more data.  

Triverus was engaged to create an Information Asset Management (IAM) roadmap with the goal of establishing an enterprise information architecture to guide the identification, storage, protection, transmission and access of vital information assets in support of business objectives. The IAM initiative was focused on identifying critical data and documents used in core business processes across the organization with the architecture, methods, policies and procedures used to manage the company's information assets.  

The IAM Roadmap provided a current state view and initiative definitions sequenced across a 3+ year time horizon that answered the following questions:

• What are the critical information assets?
• How and where are assets currently managed?  
• What information is managed by, or shared with, external organizations?
• How are trade secrets and intellectual property managed?  
• Is information readily accessible, timely and accurate?
• Are all assets protected appropriately?  
• Are information management methods compliant with applicable regulations?
• What opportunities exist for productivity gains, data management process improvements, and improved decision making?
• What future initiatives will improve compliance, efficiency and effectiveness in managing information assets?

Challenges

The company wanted to balance enterprise scale architecture, policies and procedures as it related to IAM in a manner that was consistent with their culture and their startup mentality. That meant the roadmap had to be deft at introducing IAM formality into the culture so that it was not rejected by the culture, but instead embraced as the way the client operated.

Results

The roadmap supports the establishment of information management capabilities to not only keep pace with, but more importantly, anticipate and stay ahead of upcoming requirements to enable the company’s growth in supporting:

• Clinical trials and subsequent submissions
• New types and volumes of clinical data (e.g., subject, supplies, safety)
• New sources and third-party service providers
• New requirements for handling of the information (e.g., 21 CFR Part 11)
• Increased regulatory compliance requirements and scrutiny  

How We Helped

Triverus followed their proven approach for establishing an Information Asset Management (IAM) Roadmap. The IAM Roadmap defined a series of steps designed to achieve a series of interrelated objectives:

1. Enabling the information management capabilities required for the IND submission;

2. Ensuring readiness of information management capabilities for subsequent clinical activity; and

3. Enabling overall scalability and effectiveness of the information architecture throughout the company as it grows and evolves.  

Triverus deployed a team of experts in life sciences, information asset management and information security to define the roadmap.