Pharmaceutical Industry

Overview

In the past, pharmaceutical companies were able to prosper with a focus on successfully discovering, developing, manufacturing, and then marketing their products. With the pharmaceutical industry in a state of flux due to rapid technological advancements and increasing competitive pressures, companies are being challenged not only by changes in R&D, supply chain management and pricing pressures, but also by regulatory pressures and an increasing volume of litigation.

Managing demanding regulatory response and ongoing litigation across numerous jurisdictions in civil and sometimes criminal matters have become a normal course of business for most pharmaceutical companies. All the while, companies must keep up with the increased complexity of managing electronically stored information (ESI). Traditionally, most pharmaceutical litigation support teams have relied on outside counsel to control each matter, and that outside counsel has often relied on local counsel. By turns of complexity, volume and frequency, the corporate client has lost transparency and ultimately, accountability over their departments and data as cases spread out over different law firms’ networks. The result is duplicate copies of data inside different law firms with little visibility or control by the corporate client.

Because the same documents are often reviewed many times for similar matters, corporations face increased risk from documents being produced in one case but withheld in another. Furthermore, corporations pay multiple times for the same documents to be collected and reviewed, without the benefit of the work product from previous cases. This leads to duplication of effort, lack of coordination, and increased cost.

Challenges

To minimize risk and expense, pharmaceutical companies must gain more control over the litigation process without impeding their counsel’s ability to handle the matters. They must ensure that documents are fully secured and made available outside the corporate firewall to authorized users from approved law firms and to third-party experts.

Additionally, they need to provide access to outside firms for some cases, while simultaneously restricting access to others. Corporations must impose greater control over the Discovery process, updating procedures to satisfy the new FRCP requirements, to meet the demands of regulatory compliance with government agencies such as the FDA, and to maintain the security of clinical trial data and intellectual property. 

All of these challenges must be met cost-effectively, in a manner that increases cost predictability for corporate budgeting purposes without ballooning the complexities of litigation management.

Solution

The CaseCentral® Corporate Edition™ is an ideal solution for the above described challenges, turning discovery into a repeatable business process. A standardized workflow on one centralized, secure platform enables the efficient management of massive electronic discovery and ongoing response to regulatory inquiries from government agencies such as the FDA. Evidence loading time, costs and errors are greatly reduced by direct data connectors to corporate IT systems such as email archives and content management applications. Administration is centralized within the corporate litigation support group, who maintains control over matters and evidence by granting access to outside counsel on a firm-by-firm and user-by-user basis. When a document is reviewed, all of the values added by each firm are retained, including designations, annotations, and redactions. This builds an institutionalized knowledge base that can be applied across future cases and regulatory response. CaseCentral scales easily to meet the demands of increasing data volumes and case sizes with no in-house IT maintenance or expense.

Benefits

• One centralized review platform delivers unprecedented transparency and control over regulatory response and litigation activities across law firms
• One centralized review platform also minimizes the security concerns that come along with production of sensitive information outside the corporate firewall
• Repeatable, defensible business processes including clear chain-of-custody address compliance with the new FRCPs governing discovery
• Reuse of administrative settings and work product across cases increases accuracy and speed, as well as incremental cost savings with every new case
• Reuse of prior work product also reduces business disruption and demands on IT staff
• Flexible platform architecture enables adding hundreds of users in a snap, while integration with corporate email and document repositories reduces loading time, costs and errors
• Scalable implementation ensures high performance access to tens of millions of documents
• Hosted services minimize startup time and cost while also simplifying ongoing management
• Predictable pricing facilitates effective litigation budget management

 

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