Triverus worked with a Life Sciences company on a Data Protection Strategy following the launch of their first commercial product. As part of this engagement, Triverus led the assessment of the client’s information exposure and developed an actionable set of initiatives to address the information protection needs of the client’s growing business.

The Finance Department required a significant effort to reconcile the value of inventory in the inventory sub-ledger and the general ledger. Failure to complete this reconciliation could create risk for Sarbanes-Oxley compliance.

Triverus helped a Life Sciences company understand their current state of information storage, transfer and access, identified potential risks and recommended future state improvements to the organization’s data access and protection.

The client, a commercial biopharmaceutical company, has rapidly expanded the number of clinical trials it was conducting to over 180 clinical trials, across therapeutic areas, in various sites across the globe. To support their clinical operational reporting needs, they have been using a packaged solution from Oracle which addressed some out-of-the-box needs. Due to pain points in their existing reporting, the client began to move away from predominately using Oracle applications to using applications from other clinical vendors such as Veeva (Veeva CDMS and Veeva Study Startup) and Medidata Rave’s EDC solution.

In today’s digital world with increased remote work, organizations are handling massive amounts of data which is stored electronically. It is necessary for companies to retain data as efficiently as possible so that if they need to retrieve that data in the future, they can do so quickly and potentially save time and money. If there is a legal incident, having organized data in place will minimize costs and the time it takes to collect data. According to Transparency Marketing Research,  the global e-discovery marketing is expected be valued at more than $25.9 billion in 2031, due to the rise of digital data. With these rising amounts of data, companies cannot overlook how their data is retained and structured.

Our client, a pharmaceutical company founded in 2002 by a team of distinguished Life Sciences leaders, is advancing a pipeline of innovative RNAi-based medicines to transform the lives of people living with diseases for which there are limited or inadequate treatment options. As part of its Data Governance initiative in response to an audit, the company was seeking a partner to develop an enterprise program to manage and operationalize data retention in a phased approach.  Triverus was called in to deliver a baseline assessment, data retention policies and procedures, a data retention requirements framework and retention and disposal schedules for structured data, unstructured data, and third-party retention of data.

A pre-commercial biotechnology company was preparing for the commercial launch of a new treatment for which they were expecting approval in the next 12-18 months. They needed to develop a roadmap to stand up several new business functions and accompanying Information Technology capabilities and also ensure that roadmap timeline was adhered to, to support a successful launch.

The company was looking for a trusted partner that understood their business needs and financial constraints to develop and manage the IT enablment of  a launch roadmap that would maximize business value while controlling costs.

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?

The client, a clinical stage pharmaceutical company, dedicated to developing potential therapies for neurodegenerative diseases was seeking a partner to assist in developing a sustainable enterprise data protection program to mitigate data liability, support regulatory compliance and serve the needs of the business. As a result of the engagement, Triverus successfully delivered a baseline assessment to understand the client’s cyber security environment and identify gaps, a high-level program roadmap to improve the company’s data protection posture, a management model for program oversight and a foundational set of security policies and procedures.

Triverus led a strategic engagement focused on a new, global, Cloud-based Analytics Platform focused on helping customers leverage their laboratory data, metadata, improve processes and compliance. This platform also implements advanced data analysis to understand and respond to customer usage of both hardware and software products to further develop and deliver enhanced and new products and services to the marketplace. This program focused on enabling three distinct teams to plan and execute high quality software delivery with predictability, adopt lean-agile principles and practices, and work with senior leadership to implement continuous improvement across the organization.

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.

At a pre-commercial biotechnology company, Triverus was engaged to execute a Commercial Launch Roadmap engagement. At the time, the client was 12 months from launch but had no IT presence in the organization. Triverus met with business leadership across the commercial, supply chain, medical, market access, finance and HR groups to determine the needs of the biotechnology company and define a right-sized roadmap and budget for launch.

A clinical-stage biopharmaceutical company, focused on developing therapies to improve the lives of patients diagnosed with cancer, received “priority status” for its first approval.  Being fast-tracked for approval heightened the need to quickly transform the company from a clinical development organization to a commercial one.

A biopharmaceutical company had defined a strategic goal of simplifying and enhancing its global regulatory compliance capabilities. The company had adopted several compliance tools but had yet to define the required business rules and configure the tools effectively across their organization.  

Triverus worked with the organization to assess its current data governance capabilities and implement a program to meet the company’s data privacy and records management goals within three quarters.