Mission

PRIMO’s mission is to (i) develop and advance records and information management solutions in the pharmaceutical industry; (ii) provide an open forum for pharmaceutical records and information management professionals to discuss the unique information management challenges and opportunities in the industry and to share information and best practices; and (iii) promote recognition of the vital role of effective information management in the research-based pharmaceutical industry.

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Goals

  • Provide a forum for dialogue, benchmarking and consensus-building on pharmaceutical industry information and records management issues of common concern, including both electronic and paper records and information;
  • Discuss and develop solutions, strategies and tools relevant to managing pharmaceutical records and promoting effective information management;
  • Contribute to more effective regulations and standards by communicating PRIMO’s consensus positions to U.S. and international regulatory and standard-setting bodies; and
  • Develop materials that underscore the business case and help internally educate employees and top executives on the need for and increasing complexity of information management.
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Background

For research-based pharmaceutical companies, effective information storage and records management is essential but challenging. Research and product development data; sales, marketing, manufacturing and financial records; and other informational assets are voluminous and ever expanding. The FDA, FTC, SEC, IRS, and other bodies, and their foreign counterparts, all impose strict records retention requirements, as well as penalties for non-compliance. Additionally, companies have a duty to preserve all information relevant to pending or anticipated litigation (whether related to, for example, intellectual property, product liability, or any other claims) or when on notice of a criminal investigation (e.g., investigations concerning antitrust, false claims, or FCPA). The 2006 amendments to the Federal Rules of Civil Procedure now make clear that electronically stored information is subject to discovery. Moreover, these information retention needs must be understood in the context of a world in which technology is rapidly advancing and communication practices are changing. Adding further complexity, privacy laws may place restrictions on the retention and use of records containing personal data.

An organization’s approach to records and information management must be driven by its specific regulatory and business needs. Regulatory obligations pharmaceutical companies must comply with are particularly complex, and large pharmaceutical companies are continuously involved in litigation and e-discovery. The Pharmaceutical Records and Information Management Organization (PRIMO) works to address these challenges and improve information governance within the pharmaceutical industry by conducting benchmarking, developing compliance tools and good-practice approaches to records and information management, and promoting workable RIM standards.

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Benefits of Collaboration

  • Due to the increasing volume, cost and complexity of records and information management in the pharmaceutical industry, sharing pre-competitive knowledge and techniques can improve the effectiveness of each company’s programs, and cross-fertilization of ideas can generate new insights or perspectives.
  • Global pharmaceutical collaboration can provide faster and more cost-effective development of Records and Information Management (RIM) programs, avoiding needless duplication of an individual company’s resources and resulting in a more complete, shared toolbox.
  • An industry’s power to influence regulatory and standard-setting bodies is strongest when the industry speaks out on shared goals with a common voice.
  • Collaboration can broaden and enhance each company’s network of RIM experts.
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