DCL Learning Series

Marianne Calilhanna:

Hello and welcome to the DCL Learning Series. Today's webinar is titled "Accelerate Life Sciences Content Creation by Augmenting Industry Guidelines." My name is Marianne Calilhanna, I am the Vice President of Marketing at Data Conversion Laboratory, and I'll be your moderator today. Before we get started, I want to let you know we will allow time at the end of the webinar for questions and answers, so please write and submit your questions whenever they come to mind. If we don't have time to answer all the questions we will get in touch with you personally after this webinar. This webinar is being recorded and it will be available from our website at dataconversionlaboratory.com.

Before we begin, I'd like to provide just a brief overview on Data Conversion Laboratory or DCL, as we are also known. Our mission is to structure the world's content. Content can unlock new opportunities for innovation and monetization when it has a foundation of rich structure and metadata. For content to be easily discovered and used across various platforms, it should be converted into an XML format, from which machines can extract pertinent information.

Marianne Calilhanna:

And DCL services and solutions are all about converting structuring and enriching content and data. We are one of the leading providers of XML conversion services, data conversion, structured product labeling or SPL conversion, and S1000D conversion. DCL is best known for its excellent customer service, as well as working with complex content and data challenges. And we work across many industries, here on this slide are just a few of the representative customers with whom we engage across the markets we serve. So we have a lovely panel lined up for you today. I'm happy to introduce Mark Gross, President of Data Conversion Laboratory. Ann Rockley, CEO of the Rockley Group, and Val Swisher, CEO of Content Rules. Mark, I'm going to turn it over to you.

Mark Gross (2:39):

Okay, thank you, Marianne. So just in terms of FDA approval and working in the pharmaceutical world, I thought was some interesting facts about it. This is not meant as a history of the FDA and its oversight of pharmaceuticals, which is a fascinating history by itself. But it's interesting I think that, less than 120 years ago, there was almost no oversight at all, there was no regulation. It was started with in 1906 when Theodore Roosevelt signed into law the Food and Drug Act, which merely prohibited the interstate transport of foods and drugs that had been adulterated. As they weren't checking anything other than it had to match what the label said. Other than that, nobody really did very much of anything, no pre-evaluation, didn't deal with false or fraudulent claims, that was it.

Mark Gross:

It wasn't till 1938, right at the height of the depression really, that, FDR Franklin Delano Roosevelt, put into place, the Food Drug and Cosmetic Act, which was really a result of a lot of scandals that happened to the 30s and those muckraking journalists of 1930s who were after him. It was after a hundred people died in 1937, in what was called the Elixir Tragedy, which an elixir sort of drug, which was toxic and untested, was sold as a drug. So this Act was the first time it really mandated a pre-market review of the safety of new drugs. It banned false claims, authorized some level of enforcement, but nothing not much other than that. By the way, I thought it was interesting, I didn't know that FDR and Teddy Roosevelt were were related, they're fifth cousins and Eleanor Roosevelt, who was Teddy Roosevelt's wife, FDR's wife was actually Teddy Roosevelt's niece, so it's a little fact for those trivia games.

Mark Gross:

So this expanded over the years, it was until 1962, the Kefauver-Harris Amendment, which was really the revolution at the regulatory authority, it's not that long ago. And it required new drug applications would actually would show substantial evidence, was a terminology of a drugs efficacy. So it was until 1962 did you actually have to prove that a drug actually did what said it did. Now, all that over the years has meant more and more documentation, support drug applications, and in the days when paper filings required, it was not that long ago, I think twenty years ago, you still have to do much of that. There are many stories of semi-trailer trucks like this one, pulling up to the FDA to unload the required paperwork. So that's a lot of paper.

Mark Gross:

Today the delivered documents is electronic but still I think that visuals is helpful and understand just how much content you need to deal with them you're dealing with pharmaceutical applications. And today the need for speed and communicating is higher than ever. The current situation with COVID just highlights the life-saving importance of being able to process a drug and get it to market very, very quickly, but even in normal times, research moves quickly and people are waiting for life-saving cures and it's all waiting for the proof of efficacy to be proven in providing, it's certainly more prosaically in addition to saving lives. The faster the market, the quicker companies can make sales, and the longer they have patent protection, which runs out after a certain number of years, and that all pays for the next drugs to be developed. Next slide please?

Mark Gross:

Which gets us to controlling and structuring content in an environment where you're dealing literally with millions of pages and charts and other kinds of information, which has to be shared, has to be shared with lots of people these days, lots of people involved, we share with researchers, contractors, partners, the regulatory authorities and others, all of which makes it much better to work with structured content, so that you can really work with it and find things. And also to follow standards and everybody's working with the same things. It's much easier if everybody's reading documents in the same way as you're producing them, for them to be able to respond them and test them and look at things. And it's really hard to find things in that semi truck trailers, so organized structured data speeds up the process, makes it easier, and it's a very expensive process today so anything you can do to make it easier and less expensive and quicker is very important.So to speak to this today it's my pleasure to have with us two world renowned experts in the field, Ann Rockley and Val Swisher, and I will now turn over the microphone to Val to introduce herself.

Val Swisher:

Thank you so much mark and thanks for having me on this webinar and hi everybody. My name is Val Swisher and I am the CEO of Content Rules. I had a fundamental belief that content should be easy to read, efficient to create, and cost effective to translate. We're going to be talking about aspects of that today. I am the author of three books. My third is, Global Content Strategy, A Primer. And in October, I will be releasing my fourth book which will be called, The Personalization Paradigm, Why Companies Fail and How You Can Succeed at Delivering Personalized Experiences at Scale, and boy that's a mouthful. Next slide please. So I started the company in 1994, we have worked with hundreds of customers, we've worked on thousands of projects, we are extremely proud to be the exclusive licensee of the Rockley Method. We are hand-trained by Ann Rockley, which doesn't get better than that. We are also very proud to be a partner with DCL, and with that I will turn over to Ann and next slide please.

Ann Rockley:

Thank You Val, and thank you Mark. So I'm Ann Rockley and I am CEO of The Rockley Group. I was named the mother of content strategy, mainly for really introducing the concepts of content strategy to the industry through my first book, Managing Enterprise Content, A Unified Content Strategy. Over the years, it's been even more important for me to develop methodologies to help people understand concepts, to find better ways of creating and delivering content. As part of that, I was the creator of the Intelligent Content Concept, and the Intelligent Content Conference, which helped others to focus on putting content together in a more effective way. And yes I do have Master of Information Science. So as I mentioned, Managing Enterprise Content, that's the first book. There's Intelligent Content, A Primer.

Ann Rockley:

I have worked in the industry, as a consultant, for more 30 years, but in particular in life sciences for over 20 years. And I've worked with life science materials from many different perspectives, so from clinical, so dossier information and labeling, and also from promotional, from the marketing perspective. So we are industry experts and structured component based content strategy, content reuse strategies, and structure content management systems, helping companies to select the most effective one for their needs. We also work with content global strategy and we always work with content rules when we're focused on a global environment. Next please.

Ann Rockley:

These are our clients, and as you can see, we have worked across many different areas of Life Sciences, from pharma medical devices, healthcare organizations, a variety of different types of companies in this area for quite a long time. Next. So I wanted to start off by talking about the pressures that life sciences companies face today, and obviously the first one is time to market. There's a huge pressure to get your products approved and out to market first, because when you get it out, there you do acquire a very large share of the market. Anyone following behind will not get quite the same breadth and depth of the market as they go forward. So when we've got that pressure on time to market, we also have increased shareholder expectations, and they're looking for profit, obviously. There's increasing competition, we see it over and over again, that there may be many different companies who are developing similar types of drugs or medical devices at any point in time, and again, it's extremely important to find the best method for getting your product to proof, which means lots of content, as Mark said, and getting out to market.

Ann Rockley:

There's also increasing regulation. There's always been, well not quite always, according to Mark, but there's an emphasis on making sure that the products that you create and deliver, meet the standards, that they are effective, and that we are increasingly making people aware of any potential contraindications. So we see regulations increasing and changing all the time and we have to be able to adapt our content quickly to meet those changes. Next.

Ann Rockley (13:29):

So to continue on, on the concept of issues, it is difficult to manage content, actually large volumes of content. The equivalent of hundreds and hundreds and hundreds of thousands of pages of content, to make sure that the content is valid, that the content is of good quality, that it's meeting all the regulatory and legal requirements, and that you can create it, and assemble it, and get it out to the health authorities of FDA and EU, and others, as quickly as possible and with minimal cost. It's really hard to locate content when you've got that massive volume and you've got many different teams working on that content. So if you are not able to locate the content and pull it together in a consistent way, it makes for cumbersome reviews. And often within an organization, there are many different standards for how that content is created, especially if you have a quite a diverse product line, and you'll have different teams who may be creating their protocol in quite a different way then another team is, and it's published in many different formats going forward, and many different languages, and it may be tagged with different metadata, so that makes it even harder to find. Next please.

Ann Rockley:

So content, we have found, as we've done our analysis over time with each and every organization that we worked with, it is inconsistent from document to document. It's very difficult to find all occurrences of content to ensure that it's consistent. Copy, paste is just not sufficient anymore, you cannot trace, you do not have an audit trail with that. Cost of translation is very high, as you move into the label, and you start sharing your content out to the organizations that will use your product. And because content's inconsistent you end up with content being translated and retranslated and retranslated. I already mentioned competition means timelines are shorter. We have seen R&Dd productivity declining where companies are putting huge sums of money into R&D and it's not always profitable at the other end. Costs are increasing for a variety of different reasons and of course compliance. Next.

Ann Rockley:

So what is the challenge. Worked with hundreds of companies over the years, and while there is, to a certain extent, a set of standards that everyone follows, ICH being one which provides structure for a lot of your materials and some authoring guidance, some writing guidelines associated with it. But it is fairly open and there can be a lot of variations in that. And one of the drawbacks with ICH is it was never designed for modular reusable content, and we do have research that proves if you can create your content in a modular way in components, and then design it right at first and then reuse it across your document sets, you can speed up your time in terms of development and to market quite significantly. So just in the last couple of years, can we go back please? Just in the last couple of years, we've started to see a lot of discussion around TransCelerate BioPharma Inc. and this is very fascinating because it is providing guidance for modular reusable content. But one of the challenges with TransCelerate is that it is a private organization with members that join it, so that it's not necessarily as accessible to everyone across the board. Next.

Ann Rockley:

So what's the solution? A unified content strategy. So a unified content strategy is a repeatable method of identifying all content requirements up front, creating consistently structured content for reuse, managing that content in a definitive source, and automatically assembling content on demand to meet your needs. Next. We are using a unified content strategy in many different areas as I was saying in the beginning. So we're using it in clinical, with a clinical study report, a summary of clinical safety, SCE, CO, others. And of course in labeling with the core data sheet, the USP, the SmPC, and of course many, many other areas. Next.

Ann Rockley:

So there's a number of benefits associated with creating a unified content strategy. Next. One of the biggest things is, it's less work to create content, it's less work to maintain that content, it's less time to review the content, it's higher quality and consistency. And the reason for this is because you're creating very structured content that is modular and designed for reuse, write once, use many, create once and review once along with it. You, of course, get better use of resources, so we have repetitive processes are reduced, and you get more value added work. So instead of people working on the mechanics, trying to make sure it's all consistent and you got the right information in the right place, you're putting your time and effort into the message, into the strategy associated with that message and ensuring that you are communicating as effectively as possible. Next.

Ann Rockley:

There's increased consistency. If you create content once and you reuse it multiple times, then you can be assured that everywhere that that content appears, it's consistent. And by having writers follow structure and following structured authoring guidelines, it's also more consistent, you don't get all sorts of different ways of writing the same type of information. Next. You have improved quality because, again, once you've written that content and it's reused, you can guarantee that it's accurate and consistent. And your reviewers are looking at that content in many different contexts but the one piece of information, so you know you have improved quality. It's structured for consistency and readability. Next.

Ann Rockley (20:53):

So a unified content strategy defines, what is the structure you want to apply to your content? Does it differ from the standard in the guideline? Are you starting off with ICH and then you are modifying it? Where are you modifying? It where does it differ? Why did you decide to make that decision to have it differ? What are the variants? So we can create consistent content but we know that as we produce our information, that we have to vary it, maybe your CSR varies based on the phase of the study that you are reporting at that point in time. Maybe it's the disease condition, so you'll have one variation, say for oncology and another variation for something else. But each and every time you work with that variation, it's consistent within the context of that variation. And there can be other reasons why you might have variants, but you're very clear in defining those variants and you're consistent with those variants.

Ann Rockley:

You take a look at the information and you communicate to your medical writers and your co-authors what part of that structure is mandatory, what's required, how much of it is optional, how much of it is dependent upon a certain situation being true or not, say for example that, if you're writing about a small molecule, well then you want to use this type of information, but if you're writing about a large molecule, you should be using a different set of information. And how structuring is the actual content when you get to it, so if you're looking at the paragraphs and the phrasing and the way to put together your information, how structured is that, how consistent can that be, can you actually come up with almost boilerplate content that of course you have variations for data and variety of different things like that, but how structured could you make it so that the focus is on, as I said before the message, and less on the tweaking. Next slide.

Ann Rockley:

So if we continue into this, into the detail, what content is for writing guidelines only? So in some cases you can't 100% structure it, but you could give some really good guidelines. How much of it is standard? What are the variables? What's the data? Where's it coming from? Can you tie it directly into the production of the of the data that's associated with your information? When you get into the content, how much of that varies? So you use this paragraph in one situation use that and another let's say if there were a small number of deaths, you have this standardized content, if there were a larger number of deaths, some other piece of standardized content, well what if there were no deaths, well then you have yet a third standardized piece of content. So you know how it's going to vary you have defined it as part of your content strategy. Next.

Ann Rockley:

And then we are looking at a reuse strategy, so what does a reuse strategy do? Well, one of the biggest things with a reuse strategy is we are able to define a pattern for that information, so that certain types of information may be is always created in one location, reused in a summary or in a conclusion. We identify very clearly what is the source, what is the single source of truth for that content? Where is it created and where is it reused? What is the target, so we know exactly where that is? What content is planned for you, so we can determine it in advance? And what might be ad hoc where we're not going to know because it very much may vary based on the clinical study in the trial. We define whether content is verbatim or as-is, meaning you don't change it you simply reuse it the way it is. Or if you can make a modification to it, for derivative reuse, which is reuse with change. We figure out, what is the granularity of reuse? Are we talking about components? What about sub components? Are we going down to something even smaller, like a fragment or a sentence? Or maybe you don't want to support that kind of reuse, it is a little bit more technically challenging.

Ann Rockley:

Or what about going up in size, can I reuse a whole section somewhere? Where can I reuse that section? This is all part of your planned reviews. And once you know all this information, if you're going to carry your content into something like a structured content management system, you can define how content will be reused, whether it's automated or manual, so based on your reuse strategy, you can auto-populate downstream documents with a clear definition of plan reuse. Next.

Ann Rockley:

So there are multiple pieces of a content strategy, the content model, and the reuse map. Next. We have sequential reuse, which is, I'm showing an example here just visually, I'm just showing four different documents that are common. So the CSR, the SCS, the SCE and the CO, and sequential means that you're reusing that content from document to document and you may then use it from where you reused it, you reuse it again next. Next slide please.

Ann Rockley:

Then what many companies are moving towards is a single source of truth. This is particularly important in a structured content management system, so then you have a library of content and you reuse from that library so the content is first created, the blue, and then reused into the CSR, and you can see how it comes out of the library into the CSR, the SES, the SCE, and the CO. And we can see that being pooled pulled across. Next slide please. We can also have reuse within a document so intra-document reuse. So you could create it early on in the document, where it's more explanatory, and then you pull some of that key information into a summary or a conclusion. Next.

Val Swisher:

What does a content model identify? Well, in order to reuse content and be successful at it, the first thing you need to do is develop the structure of that content that you're going to reuse. So when we create a content model we're doing many things, and among them we're separating the content from the format because the ultimate format of that same content will vary from use to use. The content model enforces consistency and that allows us to strategically reuse the different pieces of content. It's all part of your plan, it's all part of your content strategy. And as we've been saying, when we reuse content when we structure it, when we have a model for the different types of content, then the quality of that content goes up and the amount of effort it takes to create that content goes down. Next please.

Val Swisher:

So among the things that models define, models are really important. Of course, models define the purpose of the content, define the semantics that we're going to use associated with that content. Models define a hierarchy of content, so what is above what? What comes from what? A model defines the level of granularity that we want to get to, in terms of reuse. So it could be something as large as a component, it could be even smaller and smaller and smaller. So large as a paragraph, multiple paragraphs, sometimes we even get down to the sentence level. How we're going to reuse it, we're going have boilerplates, so some of your content can just be auto populated, when you plan the reuse. And of course, we always have guidelines that go with all content modeling. Next.

Val Swisher:

So when you develop content models, you're going to develop a couple of different kinds. And the first, you're going to develop an information product model. So that's a document model that the big model, into which, you will put all of your reusable components. So we need that type of model that structures our final output. Now remember, that's not the format that's the structure of the content itself. And then we also have component models, so each different component that goes into that final information product, what is the structure of each part of those models, each component? So you're going to develop your corporate content structure and then of course, we know, that we're going to have variables because when we reuse content there will be times, in that content, where we have to swap out different things according to our data, and we're going to be able to map the variables to the data.

Val Swisher:

When we work on a structured writing project, can you go back one slide? When we work on a structured writing project, we always make sure that we develop structured writing guidelines. So these are guidelines for all of your authors so that they understand how they need to write in this type of scenario. How do you write in components and how do you write for reuse? Because if you know in advance, we're specifically going to be using this component in these different things, we need to make sure it's written in a way that that component can be used in multiple circumstances. Next please.

Ann Rockley (32:21):

So this is an example of a content model. It's only a fragment because you can't possibly see the whole thing on a slide, and it is a simple one, it's the prescribing information, and so the label. We have a fairly basic structure down the left, which is consistent, typically from organization to organization, but we're starting to, as we get into the model, we want to understand the usage. Is it mandatory or is it optional? So they M for mandatory, a black box warning obviously nobody wants that in their label, so it is optional. And we have a statement in terms of when you would use that or when you wouldn't. What is some of the boilerplate? Are you boiler plating the titles? We're only showing titles here to a certain extent until you get down to towards the bottom of the model and you can see, we're getting into the boilerplate text itself. And things like phone numbers, if you boilerplate this and you create a placeholder for phone numbers, you can automatically change that number depending upon the region where that content is going to. Next slide lease.

Val Swisher:

So in order to be successful reusing content, we really need to plan it as much as possible in advance. So we create what's called, a reuse map, and the reuse map identifies a number of things. Of course, it identifies the source and what we're creating, it also identifies the target, and are we going to reuse content as is, or do we need a derivative of that content and how are we going to do that? It also defines whether this particular piece is required or if it's optional, and then it defines the condition, what must be true in order to be able to reuse the content? Next please.

Ann Rockley:

So this is an example of a reuse map, again, a fragment, they can get very, very large and just showing it here generally, the development does take place in some sort of a spreadsheet. But then we can see a CSR section where the content is created. So the C for create, where in what section is it reused? In the SES. In what section is it reused? In the CO. Are there any conditions associated with it, so adverse events that led to dose modification. Well, if dose modifications were permitted, then you're going to have that section but otherwise, it will be deleted and things like pregnancies, it may be required in some cases it may be optional. So we are planning out where the content is sourced from, where the target is, as it goes downstream through the information. Next please.

Val Swisher:

So when you're using content models in the reuse map, there are a bunch of things you need to do. One is, we're going to have some authoring template. So we're going to have to guide the creation of those templates. And as we've been saying, we really need to have structured authoring guidelines so that everybody understands how to create the content and the different things that are put into place in order to support the structure. We generally build these templates in the structured content management system, and we set it so that it's auto-populates where it's supposed to. And of course, it supports the automatic creation of content, that's what reusing and modeling permits. Next please. So the ecosystem of structured content is a bit different from what we're used to, so let's let's look at the components of that. Next please.This is the end product, and I'm going to go through each piece of your structured content management system so, next please, we'll start with the first part.

Val Swisher:

So we start with content components. So again, these are small chunks of content that are reusable, they're created according to the structures that we have defined. So we've defined the structure of it, and now we actually create these components in individual chunks. Next please. Along with creating each component, we need to make sure that the components are tabbed with the appropriate metadata, because we need to make sure that, first of all, everything is categorized and in order to reuse content, we actually have to find the content, and we need to pass the content in such a way that we can back to that library and find the content when we need. Next please.

Val Swisher:

This information is all stored in a structured content management system, and this is a library that we were referring to earlier. A structured content management system is essentially a database, it's a database that contains these small chunks of content, organized using a taxonomy, which is usually hierarchical, but could be flat, and each piece of content that goes in, each component, is tagged with the metadata that we need to help categorize it and again find it when we need to find it. Next please. It's at this point, when the content is created and we're putting it into the SEM, that we can also apply various content optimization techniques. So for example, we need to make sure that our terminology is consistent throughout everything that's going to be in one of our deliverables. It could be disastrous as we don't consistently use the same term all the time. This is where we can optimize the content, where we can apply quality scores to the content, to make sure that each component is at the highest level of quality that it can be. Next please.

Val Swisher:

And we also store all of the localized versions in with the target, and this is really important because that keeps all of our localized versions in sync with our original source. So if I make a change to a small component, and that change needs to go out for translation, well we really only want to send that one small component to translation. There are many reasons not to send everything back to translation, including quality, consistency, and of course speed, time to market, and cost. So this is your entire structured content management system and all the different pieces that you need to develop a used content in this way. And with that, DCL now plays a very big role in the process and I will pass it over to Mark.

Mark Gross:

Okay, well thank you very much, that was terrific. Val, Ann, that really was terrific job. So I guess the next step is, well how do you get started, do you have to build all this from scratch and how do you get all those documents you've been building for the last few years in into a system like this. And that's a place where DCL plays, I mean, first of all, we do have the technology that'll let us take your documents in whatever form they are and and turn them into this standard [inaudible 00:41:32] system. And whatever the stand is that you end up choosing, because as we saw that a lot of guidelines and there are specializations in terms of how you're gonna use this data, but there is soft, and we can take that pile of documents, a pile of information whether it's coming in Word, it's coming in, some on paper still, coming in and one kind of XML and now it needs you move... so that's that's an area that that we can help and that really speeds up the process tremendously because you don't have to start rewriting everything from beginning, you can just use whatever you have, those are tremendous assets you've got and next slide.

Mark Gross (42:19):

And the other tool I just wanted to talk about, is we've talked a lot about reusable content and reusable pieces of content and the question's how do you how do you find all that because chances are if you've been working for years on various kinds of documents, those pieces are already in the documents and they've changed a little bit, they duplicate, the same section my appear in a hundred different documents. So among the tools that DCL provides, is a tool called Harmonizer, which as it says, harmonizes your content. It'll go through an entire set of documents, a hundred, a thousand documents, a million pages, and identify all the paragraphs or all the sections that are either identical, and this is very important, or are similar to each other because things morph as they go from place to another, people add commas and semicolons or take them out or they change a word. So identifies them, not just identical, but also the ones that are similar and produces charts like this, which are summary charts but also if you'd open the next slide.

Mark Gross:

It also produces more detailed kind of information. It identifies all the paragraphs in a document that should be looked at that have close matches to each other, and actually breaks that down if we go to the next slide, breaks it down so that you can actually look at and see how are they similar how are they different. For example, this match group, if you look down, there's a variant A, and a variant B. They're only different by a couple of words. In one section over there that says third party and the other one it says other. Well that's pretty much the same and you may choose to pick to normalize on one of those and and then and then use that throughout your document set. And by doing this, first of all, you reduce the number of sections or paragraph subject that you have there, but you also maintain less information, as we discussed before, and is also a lot less risk that you'll make an error from one place and others a lot less time spent, not just translation, but also just legal review and all kinds of other review.

Mark Gross:

So it's really very valuable to be able to do that and this is a tool that lets you do it. It shows the way, show the two variants and on top, it's really a composite of all the variants you have. So if you've got 50 paragraphs, it might show you there's really only three or four variants that might occur over there. And on the left over there is a navigation aid that lets you go and go through the entire document set to just be able to to look at the heads of each of the paragraphs so you can just go through and see for each paragraph what variants you should you do. So it's really a tool to just help that. I think it reduces the amount of little stickies that you put into your documents and I've seen some of those, been to workshops where we're doing that and just books spread out all over with sticky pads, this sort of reduces that a little bit. And with that I think is that the last slide?

Marianne Calilhanna:

Yeah.

Mark Gross:

I think it is.

Marianne Calilhanna:

We are opening up for questions and we have a couple questions coming through, so thank you everyone. But now that we have our industry experts if we could toss a few questions your way. I think one great one just to sort of set the stage is you talked about structured content management system, but could you just quickly clarify how that's different from other types of CMS is, like a Web-CMS or an enterprise CMS?

Val Swisher:

I guess I'll take it. I'm not if Ann or I will take it. So in a structured content management system, what you need is we need components, and we need to be able to store these very small components in a way that we can find them again and again. And oftentimes in Web-CMS'. They don't really allow us to get down to that level of granularity. We also need a lot of tracking information and now all Web-CMS' can develop that tracking information. And Web-CMS' are really designed to store and manage web content, and the output that we're producing, while some of it may go on the web, is really not developed specifically for the web. So a structured content management system is really going to provide all of those elements that you need to successfully componentize your content and be able to retrieve it in small reusable chunks and then free of format, be able to marry it to some type of publishing system, where you will then be able to get all different types of content.

Marianne Calilhanna:

Thank you. This one is probably for Mark. How should one get started with the content audit?

Mark Gross:

Well, I think a first step is to do an inventory of what you have because I think very few people know what they actually have and to really classify all the documents that are going to be part of all this and first of all, determine which parts do not need to be there, but the ones that need to be there, identify what format they're in, does it need to be broken apart where does it fit into the structure so that gives you a sense of how much, how big the breadbox is, what needs to be done. And I think that that's that first step, just really identify what you have there. Once you've got that, then you can develop a strategy for how do you convert it? What kind of conversion needs to be done? Which things should be automated? Which is some things may not be enough to be worth automating, maybe it's a simpler process, or parts can be very large and really are worth a lot of automation. I think that's the first part in terms of that pre-conversion, pre-implementation kind of step.And [inaudible 00:49:23] really early because that really gives you a sense of what you've got and it develops just the whole sense of what you're going to need. It's also valuable for knowing how big a CMS you need, all those kind of things.

Marianne Calilhanna:

Mm-hmm (affirmative). Thank you um this one's likely for Ann. Where have your life sciences and pharma companies found the most bang for their buck in terms of content reuse? Is that structured product labeling? Clinical trials documentation? Marketing info? Other types of content? Could you share a little bit of your thoughts around that?

Ann Rockley:

Sure, many organizations start with the label, because the label is a small set of content. So the core datasheet, most companies have been manually creating a core datasheet over the years where, they often have an Excel spreadsheet, or maybe a very elaborate Word document, and they start to implement structured content. And from the core datasheet out to the USBI, from the core datasheet out to the SMPC, and then out of the local labels, so that's often a good first step, a foreign organization who's interested in moving forward with structured content. Working with dossier content or clinical content, there's a lot of opportunities there to improve the process and to speed up the process, but because of the sheer volume of that clinical content, it may take an organization a little longer to get started and get to a tipping point where they're starting to see that value. But in terms of size and a long-term impact, it may be the clinical where a company is getting more results.

Ann Rockley:

And then in marketing, we absolutely see some opportunities for reuse, particularly of that content that must remain the same, so a contraindication or a variety of different things like that, where if they can put those very specific, must stay the same content, in and then they can be creative around the message and the other information there's opportunities there as well.

Marianne Calilhanna:

Thank you. So this is sort of a two-fold question, how long does the content strategy take to create and who should be involved in creating one?

Ann Rockley:

That's a good question, and it always depends, it depends upon the kind of content that you're working with so as I mentioned the label, that could be done fairly rapidly so it is possible to do the analysis and the content models and the reuse strategy and in typically six to nine months and start seeing results within the year or definitely within just the beginning of the second year so that will go more quickly. With dossier content, as I said, it does take longer and you really need to structure more than one document, so say the CSR in the SES, you need to do two, before you really start to see the benefits of that and it will take longer to do that, it could be a couple of years. But then when you think about the timeline associated with clinical materials, we're often talking five, seven, 10 years out, you start creating and then take advantage of something that some product that's at a particular stage, you can start bringing in and doing pilots with it.

Ann Rockley:

And then who should be on the team? You need, obviously from the corporate side, you need really strong medical writers who have good comfort feel with the content and know how the content has been produced previously within the organization, co-authors, often you might have a variety of different types of co-authors in your organization, they're very important to have as part of the project because they're often the decision makers who say, "Yes this content is good or no we cannot go forward with this," and they often set the strategy, and so you need them involved to gain and understand, what does it mean to create consistent structured modular content for reuse? Because it was a very different, for them, it's a paradigm shift.

Ann Rockley:

You're also going to need an expert, you're gonna need somebody who understands content modeling for structured content. This is unlikely to be something that you want to sort of guess at or try to figure out on your own, you could get moving very, very quickly with a consultant you can come in and put you on the fast track so to speak, moving forward with your information. And then one area that sometimes gets forgotten, and that's you know your biostats team or the people that are responsible for the data because often in a current environment, people are copying and pasting tables or they may be having to create tables or make sure that they pull the right number off a table and put it in the content, and so if you can work with them and figure out where this data is coming from and be able to identify how you can tie it together, how you can help them to push data into the structured content for use as you keep going forward, as opposed to putting a tremendous amount of reliance on the writers who have to get it absolutely right, they've got the right number, the right cell, the right everything else.

Ann Rockley:

Now, I'll say that medical writers are very, very good at this but if we can relieve them from some of that tedium of exactly making sure, whereas they know it's right because it's automatically been populated, makes their life easier so bringing in people from a variety of different areas helps you determine where to put your focus, how to create your structured content, what makes the most sense, in terms of reuse, what you're doing today versus what you really like to be able to do, then you'll have a good solid team.

Marianne Calilhanna:

And with that Ann, do you think that does one need a structured content management system?

Ann Rockley:

Well you don't have to have one. Many organizations start without it and they start in something like Microsoft Word when they're getting started, but think about it, think how many pages how much content goes into your deliverable. Now break that up, think of for every page that you originally had you're going to have a minimum of three components, maybe five, maybe more, depending upon the granularity. So as you start to break content down into more and more component based modular content, it gets a whole lot harder to manage that content. And if you want to do things like automated reuse, you can only do that with an SCM. If you want to do things like automatic content generation, that is really hard with just a word document. So in the beginning, great, you probably don't need it. As you're doing your analysis and your early pilots, probably not, but when you get into full production, I think you're definitely gonna want it.

Marianne Calilhanna:

Well, thank you everyone, thank you Mark, Ann, Val and most importantly thank you everyone for attending this webinar. The DCL Learning Series comprises webinars, monthly newsletter, and our blog. You can access other webinars that are related to content structure, XML standards, and more, from the on-demand webinar section of our website at dataconversionlaboratory.com. I sure hope to see you at future webinars and I wish everyone a great day. This concludes today's broadcast.