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hello and welcome to the DCL learning series today's webinar is titled accelerate life sciences content creation by old hunting industry guidelines my name is Maryann Kallen Hana 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 data conversion laboratory comm 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 and DCO services and solutions are all about converting structuring and enriching content and data we are one of the leading providers of XML conversion services did a 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 challengers 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 and Rocklea CEO of the Rocklea group and Val Swisher CEO of content rules mark I'm going to turn it over to you ok Thank You Marianne so just in terms of FDA approval and and working in the pharmaceutical world I thought was some interesting facts about it it's a this is not meant as a-- a history 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 ninth 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 if 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 it wasn't till 1938 you know right at the height of the depression really that FDR Franklin Delano Roosevelt put put it put into fat and place the Food Drug and Cosmetic Act which was really 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 Luxor tragedy which Analects er a sort of drug which was toxic and untested was sold as a drug so this act was the first time it really mandated a premarket review of the safety of new drugs at banned False Claims authorized some level of enforcement but nothing not much other than that but by the way I thought was interesting almost I didn't know that FDR and Teddy Roosevelt were were related their fifth cousins and Eleanor Roosevelt it was Teddy Roosevelt's wife was it was was was FDR's wife was actually Teddy Roosevelt's niece it's a little little fact for those trivia gains so this expanded over the years it was until 1960 to the calf our Harris Act to which amendment which represented a revolution at the a 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 seda 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 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 so and today the need for speed and communicating is higher than ever the current situation would Cove it 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 sand it's certainly more prosaically in addition to saving lives too fast at the market too quick your companies and 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 develop in the next slide please switch gets us too which gets us too 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 involve share the researchers contractors partners irregular Tory authorities and others which all of which makes it much better to work with structured content so that you can really work with it and and 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 as you're producing them for them to be able to respond and and test them and look at things and it's it's really hard to find things in that semi-truck that semi truck trailers so organized structure data is 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 and Rock Lee and Val Swisher and I will now turn over the microphone to Val to introduce yourself thank you so much mark and thanks for having me on this webinar on hi everybody my name is Val Swisher and I am the CEO of content role 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 book my third is global content strategy apana and in October at we'll 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 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 Rockne method we are damned trained by Anne loftily which doesn't get better than that we are also very proud to be a partner with TCL and with that I will turn over to M and next slide please Thank You Val and thank you Mark so I'm man Rock Lee and I am CEO of The Rock Lee crew and 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 it's been Eve 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 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 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 for 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 prove which means lots of content as Mark said and getting out to market there's also increasing regulation there's always been well not quite always a turning mark there 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 to adapt our content quickly to meet those changes next so to continue on and the concept of issues it is difficult to manage content naturally large volumes of content you know hundreds and hundreds the equivalent of hundreds and hundreds and hundreds of thousands of pages of content to make sure that the content is valid 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 you know 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 place 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 it 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 is inconsistent you end up with content being translated and retranslated and retranslated I already mentioned competition means timelines are shorter we have seen Rd productivity and 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 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 IC h being one which provides structure for a lot of your materials and some authoring got and some writing guidelines associated with it but it it is fairly open and there can be a lot of variations in that and one of the drawbacks with ichs 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 we go back please and it just in the last couple of years we've started to see a lot of discussion around trans celery biopharma Inc and this is very fascinating because it is providing guidance for modular reusable content but one of the challenges with transcelerator 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 so what's the solution a unified content strategy so unify 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 the summary of clinical safety and Cee at co others and of course in labeling with the core data sheet the USP I the SNP C and of course many many other areas next 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 right once use many review once a sorry 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 you know the 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 Thanks 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 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 I CH 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 it's your CSR is is varies based on the phase of the study that you are reporting on 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 it each and every time you work with that variation it's consistent within the context of that variation and there could not be other reasons why you might have variants but you're very clear in defining those variants and you're consistent with those variants 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 on the tweaking next slide so if we continue into this into the detail what content is is for writing guidelines only so in some cases you can't a hundred percent structure but you could give some really good guidelines how much of it is standard what what are the variables what's the data where is 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 you know how much of that varies so you use this paragraph in one situation use that and another let's say it's um you know if there were a small number of desks 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 nests 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 Thanks and then we are looking at a riu strategy so what does a riu strategy do well one of the biggest things with a new strategy is we are able to define a pattern for that information so that certain types of information may be is always created and 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 it if you can make a modification to it for derivative 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 look to support that kind of raise it is a little bit more technically challenging 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 riu strategy you can Auto populate downstream documents with a clear definition of plan breeze next 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 SES the SE 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 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 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 in TRADOC youment reuse so you could create it early on in the document in where it's more explanatory and then you pull some of that key information into a summary or a conclusion next 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 so among the things that models define mommas 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 the 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 of a paragraph multiple paragraphs sometimes we even get down to the sentence level how we're going to reuse it we're going have boilerplate 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 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 to have variables because when we reuse content there will be times in that content where we have to swap out different things ing to our data and we're going to be able to map the variables to the data when we work on a structured writing project and you go back one side 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're 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 Queen so this is an example of a Content model it's only a fragment because you can't possibly see the whole thing on 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 and in terms of when you would use that or when you wouldn't what is some of the boilerplate are you board 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 if you boilerplate this and you create a placeholder for fold for phone numbers you can automatically change that number depending upon the region where that content is going to next slide please 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 most please so this is an example of a reuse map again a fragment they can get very very large and we 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 c4 create where in what section is it reused in the SES in what section is it reused in the co is 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 there 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 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 permit next please so the ecosystem of structured content here 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 so we start with content components so again these are small chunks of content that are reusable they're created ing to the structures that we have defined so we've defined the structure of it and now we actually create these components in individual chunk 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 nothing 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 chocolate content organized using a taxonomy which is usually higher up go but but could be flat and each piece of content that goes in each component this tags with the metadata that we need to help categorize it and again find it when we need to find it next screen 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 technique 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 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 huge content in this way and with that DCL now plays a very big role in the process and I will pass it over come on okay well thank you very much that was terrific that well and that really was terrific job so I I guess the the the next step is well how do you get started do you have to build all this from scratch 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 and that's a place where DCL plays I mean we 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 ID system and whatever the stand is that you end up choosing because as we saw that a lot of guidelines and and and and there are and there are specializations in terms of how you're gonna use this data but there is soft and that's uh we can take that pile of documents a pile of information whether you know 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 that 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 and the other two I I just wanted to talk about is we've talked a lot about reusable content and usable pieces of content and questions how do you how do you find all that because chances are if you've been working for four years on various kinds of documents those those those pieces are already in the documents and they've changed a little bit they're there they duplicate the same section my appear in a hundred different documents so uh a tool among the tools of 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 documen documents of million pages and identify all of about all the paragraphs or all the sections that are either identical or were and this is very important or are similar to each other because things morph as they go for and play somehow people add commas and semicolons or take them out or they change a word so it fine it identifies them ones not 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 next slide it also produces more detailed kind of information it identifies all the paragraphs in a document that should be looked at there are that have close matches to each other and and actually breaks that down if we go to the next slide breaks it down so that you can actually look at and see what what how they similar how they different for example this match group if you look down as a variant a in the variant be that only they're only different by a couple of words in in in in one section over there that says third party and the other one it says other well that's pretty much the same and 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 you can you whistle you reduce the number of sections or paragraph subject that you have there but you also maintain feet and less information as we discussed before and is also a lot less if you'll make an error from one place and others a lot less time spent not just translation but also just legal legal review and all kinds of other review so so it's really very valuable to be able to do that and this is a tool that lets you do it it shows her the way it's shown 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 and there and on the left over there is a navigation a that lets you go and in go through the entire document set to just be able to to look at the heads of each of the paragraphs even 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 crap out all over with sticky path this sort of reduces that a little bit and with that I think is that the last slide yeah we are 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 hi I guess I'll take it I'm not your banner I'll take it so um in a structured content management system what 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's 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's can develop that tracking information and web CMS's 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 thank you um this one is probably for mark how should one get started with the content audit well III think a first step is is to do an inventory of what you have because I think very few people know what they actually have and 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 if they 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 much how big the breadbox is what needs to be done and I think that that's that first step that 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 love what kind of conversion needs to be done which things should be automated which is some things may not be enough to be worth what I'm a maybe it's 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 the pre-implementation kind of step and sure you don't 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 growling you're hopeful knowing how big is CMS you need all those kind of things mm-hmm 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 sure many organizations start with the label because the label is a small set of content so the coordinators sheet most companies have been manually creating a coordinator sheet 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 USB eye from the core datasheet out to the SM PC and then out of the local labels so that's often a good first step of 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 in terms of size and and a long-term impact it may be the clinical where a company is getting more results and then in in marketing we absolutely see some opportunities for reuse particularly of that content that must remain the same so you know a contraindication or you know 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 the message and the other information there's opportunities there's as well thank you how 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 question and it 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 review 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 you know we're often talking five seven ten years out you start 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 and then who should be on the team you 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 organisation co-authors often you might have a variety of different types of co-authors in your organisation 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've you know 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 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 that 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 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 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 down you know 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 there now I'll say that medical writers are 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 and with that and do you think that does one need a structured content management system well you don't have to have one many organizations start without it and they start in something like Microsoft Word when they're when they're getting started but think about it think how much how many pages how much content goes into your deliverable now break that up you know think of for every page that you originally had you're gonna 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 you know that 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 well thank you everyone thank you mark and 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 a data conversion laboratory com I sure hope to see you at future webinars and I wish everyone a great day this concludes today's broadcast