Roger at DIA
Roger at DIA

Recently I attended the EDM and ERS/eCTD conference, hosted by the Drug Information Association (DIA). The conference is a neutral forum to discuss practical insights on addressing regulatory issues, managing change, and supporting the content life cycle.

Perhaps more than others the life science sector is supported (burdened) by a number of ever-evolving regulations. This regulatory burden adds requirements to document stringency... and also makes members of the sector leaders in document handling. It's also why Adlib features so prominently in this space.

Now I'm still learning the Adlib ropes, so I was excited to get some field experience. Being a specialized company in document-to-PDF rendering (and having spent my previous 10 years with a major F-500 technology leader HQ'd in Canada), I expected that few would know the Adlib brand and I'd be doing a lot of introductions and explanations during the show.

Boy was I wrong! In the Life Sciences IT sector, Adlib is either the center of the universe or the icing on the cake - either way, we touch everything, and everyone knows us.

We are partners with more than half of the vendors on the show floor. Every other attendee knew us, had personally deployed Adlib (recently or at their previous firms), or wanted to know where "so-and-so from Adlib" was this year! With a who's-who (though largely confidential) list of pharma clients, we've clearly achieved a critical mass that I was unaware of.

Not only was I wrong, but also I had no idea how broadly our solution fits across multiple areas within Life Science. As illustrataed in Adlib's whitepaper on 'regulating submission processing' we have a lot to offer in terms of improving the FDA submission process, but I figured beyond that I wouldn't have much to offer the audience. My anxieties were baseless, with no root in reality.

As complex as Life Science is - lots of nuanced details - and its own vocabulary - CRA... eCTD... eTMF - at its core, Pharma is working through many of the same issues as our other clients. Some of the areas that stood out for me included...

  • Document merging: I know all about Adlibs conversion and transformation capabilities, and I've been pitching for the past month to prospects around how they can more efficiently produce briefing books, RFP responses, etc. It turns out this same core offering has a large play in pharma. They call it "roll up publishing" but it's premised on the same notion - taking many disparate artifacts (they call them artifacts, not documents, who knew?!), creating one single document, and then distributing that information.
  • Paperless & eSignatures: As advanced as the Life Science sector is, and almost in spite of the many regulatory bodies, organizations are still grappling with the policies, procedures, and most importantly, people factors around going paperless. The biggest issue seems to be around staff's addiction to wet signatures. It wasn't that the regulators required a signature per se... in fact in many cases they had already declared the acceptability of electronic alternatives. But old hobbits die hard, and training staff to move away from paper is tricky. At one point we had a lively debate in the corridors on whether it was better to wean people from wet signatures to electronic signatures, or to just rip it off like a band aid and go to no-signatures. There's no right answer, and I'd like to hear how you'e handled this issue.
  • Opportunities to re-purpose IT projects: everyone is looking to do more with less and Life Science is no exception. I recall seeing eyes light up after describing how many of our clients are starting to expand their use of Adlib across multiple departments… for example, moving from a single instance in sales for creating RFPs, to a second deployment in manufacturing for distributing SOPs, using the same underlying convert-combine-enhance model. In the case of Life Sciences, the big "ah-ha" came around the notion of applying the more formal Drug submission process (and software backend) to the current "rogue" submission process for marketing promotional and advertisting materials. These scenarios rely on almost identical workflows, have similarly stringent document and records requirements, and serve different stakeholder groups. The IT administrators I spoke with are drooling with excitement about sharing this opportunity to leverage their current infrastructure investments across multiple business units.

So... while I was clearly wrong in my naïve pessimistic view that next to no one would know Adlib and I could add nothing to the conversation... I left the EDM and ERS/eCTD conference a new person... full of optimism, confidence, and enthusiasm for Adlib's ongoing growth in the Life Sciences sector.