Behind the scenes: Why medical information authors need SCA

We believe that Life Sciences organizations need a centralized platform for medical information authoring, so we’re sitting down with experts to examine some of the greatest inefficiencies in the industry. To kick off our series, we interviewed Docuvera Medical Affairs SME Kenneth Galloway to hear what challenges writers face and learn how structured component authoring (SCA) can streamline the process for the whole organization.

What does a typical day look like for a Life Sciences organization without SCA?

Medical information authors always have much more to do than simply writing. For those working in Life Sciences organizations without SCA, it can be a madhouse between SharePoint, box sites, OneDrive, and other programs. On top of dealing with multiple platforms, documents often go through multiple rounds of reviewers and edits before landing in a master system.

It takes a great amount of planning and organization so that a medical information team can tackle the needs of the larger organization. For those without SCA, one small update can mean a lot of extra work.

How quickly can (disclaimer) updates get out of control when everything is not tied to one cohesive platform? Explain what that looks like:
A single product can have hundreds of supporting medical information documents for Life Sciences organizations. In traditional medical writing, 20–40% of a medical document is directly shared with others whether it’s reused or copied and pasted.

Without SCA, hiccups can mean the death of a thousand cuts that derails an entire plan. For example, legal changes a disclaimer — a disclaimer utilized by every document. But when working across programs, authors, reviewers, spreadsheets and individual Microsoft Word documents, copying and pasting a new disclaimer over an old one creates an avalanche problem that can jeopardize other goals.

In the above scenario, authors have to comb through every folder, search the DMS, queue everything for an update and then physically insert the new disclaimer over the old one — in every single document. It’s one disclaimer, but with Word, it’s broken up for each and every occurrence.

Disclaimers are extreme examples of this, shared across a broad range of documents from FAQ, SRL, CDS and custom responses. Prescribing information, references, intended use, description of the product, list of abbreviations, and many other document components are similarly shared.

A single disclaimer change can go from one update to hundreds. Further complexity arises due to offline copies floating around with old information, resulting in an extreme waste of time and resources.

What kind of bandages do Life Sciences organizations tend to put on documentation inefficiency problems?

I haven’t met a medical information team that didn’t need another person or two on the team. The first way many Life Sciences organizations circumvent inefficiency issues is to hire more people — if the budget can be wrangled to support it — not an easy pitch.

Cheaper options to counteract inefficiencies are to implement a variety of policies. Ultimately, one of two things comes from these policies. One, they do not hold up when push comes to shove; legal can easily justify the exception, i.e., think of the risk involved with not acting now. Or, policies get in the way of future work with additional bureaucracy. Red tape to protect today’s priorities can hinder tomorrow’s progress.

A couple of effective strategies are emergent in the authoring industry to drive efficiencies:

• The leading philosophy is to only touch a document once as a reviewer or subject matter expert.
• Modular content creation allows more nimble authoring.
• Meta-data tagging and flagging documents and even paragraphs can expedite constantly searching for specific information.

But, each of the above only incrementally increases efficiency and is limited to freeing up small chunks of time instead of addressing broader issues.

How can Docuvera make a difference for medical information authors?

When medical information authors start using Docuvera, they are typically at 20–40% reuse or copy and paste. With a little skill in writing content for reuse, we observe a jump to 50% reuse, which can climb to 80% over time.

Docuvera’s reuse relationship mapping handles updates and enables writers to be more efficient. Author, review and update once — and reuse across multiple documents. In this example, instead of the nightmare of tracking down, copying and pasting a new disclaimer, checking the box, and then repeating it a hundred more times, it can be completed with one fluid action.

With the number of times a broad-reaching disruptive update comes to medical writers, Docuvera feels like hiring a whole team of writers without increasing the headcount. Technology is a tool. Maybe it’s time to ask what your technology is doing for you.

That’s my job: making sure Docuvera is the best tool for medical information authoring.