When we talk to our clients and colleagues in the pharmaceutical industry, their stories are very consistent: They are overwhelmed by the amount of information and documentation required to research, develop, approve, launch and commercialize a drug.
As one executive said, “If you think about it, we really produce two products: the marketed drug—and all of the documentation needed to support it through its lifecycle. And somehow, somewhere along the way, it becomes an information vortex.”
How did we get here?
The demand for information and documentation has grown exponentially as regulatory and compliance requirements have increased in scope and complexity. Patients, payers, and administrators are also playing a greater role in treatment and prescribing decisions, and desire increasing amounts of product information to inform those decisions. Throughout the research, development and commercialization processes, companies must capture, create, review, manage, store, distribute and track critical content and documentation.
Getting it wrong can impact approval, successful commercialization and create compliance risk for the company as a whole.
Are you trapped in an information vortex?
In a typical “information vortex,” there are many people creating, reviewing and approving information and content, using multiple tools and systems, stored in many places, shared over email or other platforms. The relative lack of process and structure leads to low reliability and confidence in the information. Knowledge workers can lose significant time searching for, retrieving and creating content, and tracking it through the collaboration, review and approval process.
When was the last time you had this conversation: “Is this the latest version of the document? Does it include the most recent results? Where is the citation for this? Has it been reviewed by Legal and Marketing?” That’s the information vortex.
But it doesn’t have to be this way.
Your information management strategy, explained
An integrated, enterprise strategy will help you define the processes and select the tools to manage regulated information and documentation across the lifecycle of the products in your pipeline from research and development to commercialization and medical information. It will drive consistency, transparency and compliance, answering a number of questions.
• What systems and tools are best suited for managing our regulated and controlled content?
• How can we make our creation and review and distribution processes more efficient?
• How do we enhance quality control and compliance?
• How can we reuse content and information around the globe and across business functions?
Ultimately, an information management strategy will drive significant competitive advantage in terms of costs, time and the quality of your information—and create a more positive experience for your colleagues, partners and patients.
If you would like to continue the conversation or learn more about the benefits of our approaches to developing an integrated information management strategy, email Mark Lane or Bruce Lotier.
