Monthly Archives: June 2017

Do you manage documents using a modern-day Frankensystem?

The way we create, review, localize, store and manage documents in the pharmaceutical industry today bears a striking resemblance to the story of Frankenstein’s monster (at least in the original film version). Several tools, systems and processes are cobbled together to manage the high volume of documentation needed to support drug development and commercialization, without much planning, testing or feedback.

How did we get here?

Like many sectors, the pharmaceutical industry is known for functional siloes, which make it difficult to communicate and collaborate across the enterprise. The challenges are magnified when multiple systems are involved, and further compounded when information needs to be shared, or when larger documents, such as submissions, need to be created collaboratively across business functions.

It starts with scattered information and broken processes. 

When you’re creating a document that cuts across functional areas, such as a regulatory submission, medical writers, subject matter experts and/or authors must spend time identifying and retrieving content, by searching across multiple systems (drives, folders, other storage systems) and emailing various contributors to find the most up-to-date content. When more than one author is involved, people must either work independently on their sections, or documents must be checked in and out, making collaboration more complex.

The evolution of Frankensystems

Identifying content, creating documents, reviewing and localizing documents is challenging enough without complicating matters further by using multiple systems. But this approach started because an integrated solution wasn’t there to support the end-to-end process, so companies addressed each sub-process as technology became available. Today, “Frankensystems” persist and multiply in the absence of an integrated strategy that brings together business and IT goals, and manages information, documents and the supporting processes.

Can you banish the monster—or at least teach it to dance?

Yes! The
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Escaping the Information Vortex

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.
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