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Building a SmartLab and Optimising Efficiency in 2013

Industry report compiled by SmartLab Exchange and PharmaIQ

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Contents
Foreword…………………………………………………………………………………………..……….3 Executive Summary……………………………………………………………………………..……......4 The laboratory informatics landscape 2012/2013………………………………………..……………5 Top challenges in current projects………………………………………………………………..……..6 Solutions most likely to be implemented………………………………………………………..………7 Information needed when selecting a service / solution………………………………………..……..8 Obstacles when getting sign off………………………………………………………………….……...9 GSK Case Study…………………………………………………………………………………………11 McLaren Applied Technologies Case Study………………………………………………………….12 Interview: South West Water…………………………………………………………………………...13 Interview: Pfizer………………………………………………………………………………………….16 Adapting Digital Signatures into your organisation…………………………………………………..19 Additional Resources……………………………………………………………………………………22 About the Exchange………………………………………………………………………….………….23

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might position themselves as high-volume. development. digital retail processes. including makers of generics. just key enablers. agile strategic pricing and inventory management from the consumer products industry. experiment. My personal goal is to contribute and assist the industry in moving from a passive to a proactive. consumer goods and electronics markets. and computation to incorporating a new fourth paradigm of data-driven discovery. Mass-market manufacturers. Internal cross-functional collaboration among research.com 3 Foreword I recently visited a conference on cross industry learning and experiences in the pharmaceutical. It appears much of the world is becoming paperless apart from in our laboratory operations. This SmartLab Exchange event will provide many opportunities including cutting-edge case studies. The use of social networking tools has illustrated that technology can enhance collaboration once some rudimentary data standards are in place. taking lessons in areas of lean manufacturing. car rental processes and a secured transportation example ending in digital boarding passes. marketing and manufacturing is not enough anymore. paperless processes. quality oriented mind-set. Big data. Research is undergoing a fundamental shift from the three traditional paradigms of theory. cloud strategies and secure deployments of mobile devices are no goals. I am looking forward to meeting you in München! Peter Boogaard Chairman. interactive forums and the opportunity to engage with a selection of one-to-one meetings with industry leading solution providers and specialist. I am delighted to be chairing this year’s 8th Annual SmartLab Exchange.www. SmartLab Exchange 2013 Take me back to the Contents page .smartlabexchange. Europe’s premier Laboratory Informatics event. low-cost providers. quality assurance. The cases presented were from across the globe and came from all industries that included studies on full paperless workflows in hospitals.

Winners will dynamically alter operations to changing business needs based on operational analytics and leverage of institutional knowledge” predicts Michael Elliot. VP Research & Development at Abbott Labs reflects. Scientific Manager of Chemistry. But. while at the same time offering an interface which is user-friendly and a significant space away from the paper designs traditionally used. There is also a desire now to have a lab informatics system which is adaptable to different silos. Take me back to the Contents page . But managing information is a challenge.smartlabexchange. The challenge for solution providers today is to provide customers with all the functions they require from their laboratory informatics system. “10-12 years after the introduction and adoption of Electronic Laboratory Notebooks (ELNs). Seth Pinsky. The concern today is whether technology is working hard enough for the customer. which deals with the day-to-day collating of 200-300 actual sample results. South West Water in the UK implemented a Laboratory Information System (LIMS).” The results are the opinions of a small percentage of the community and further analysis with a larger proportion of the community is needed to gain a wider perspective. “The corporate laboratory of the future will be adaptive and continuously optimised. The development of secure. perhaps this is something the Informatics community needs to press the vendor market on in the future. production and reporting of those results. early concerns with ELNs and other informatics solutions lay on data security and how implementing electronic systems would impact the generation and defence of intellectual property. Many are constantly changing and evolving to become more holistic in order to adapt to the increased workflow within the lab. they are likely to find themselves falling behind due to the increasing amount of data professionals are currently working with.” Not surprisingly. While the Informatics vendor market is brimming with solutions. "Balance is possible. SmartLab Exchange surveyed the network on the current state of their major laboratory informatics piece and their predictions of where their informatics lab will take them in 2015. CEO of Atrium Research & Consulting. reliable digital signatures was critical in the widespread adoption of ELNs in research. Case studies and interviews with industry leaders are also included to support the survey findings.com 4 Executive Summary The shift from a paper-based lab to a digital space is one which has been occurring for some time and labs have discovered that unless they implement sophisticated laboratory informatics. “Laboratory workers are looking for an overarching system that takes all of this information and produces a dashboard which holds all of it.www. told SmartLab Exchange. Each industry is on its own unique journey in building an informatics system. Kim Holt. we need to ask whether it really has affected our pipelines. No one perfect solution exists. but the highly competitive nature of the market and future demands of potential clients makes it a difficult challenge for any vendor” Michael Elliot adds.

00% 10.00% Vendor End user Take me back to the Contents page .www. with 75% of them selecting this. The third reason end users are looking at lab upscaling is to improve LIMS systems.00% 70.00% 0. Three quarters of the vendor market agree with this.00% 40.00% 20.com 5 The Laboratory Informatics Landscape 2012/2013 We asked both the end-user and the solution provider of the informatics community what the main drivers for those who are working with lab informatics what drivers led to investments in laboratory informatics solutions. with 75% of the vendor market selecting this same option. with 50% of respondents selecting this option while vendors believe regulatory compliance to be a reason. The main drivers behind laboratory informatics solutions 80. Improved data management appears to be the top priority for the end user.smartlabexchange. with over 60% selecting it as the reason for laboratory informatics solutions investment.00% 60. 55% of lab informatics users cited optimising for lab efficiency as their second reason for investment in the lab.00% 50.00% 30. vendors believe this to also be another reason for lab investment. we discovered that both the end user and vendor share almost the same opinions in their top 3 priorities.

“the inability to integrate systems and components through vendor provided mechanisms results in higher development and support costs. When it comes to integrating new technology. managing data flow between laboratories securely at 55% and putting standards in place for best practice data flow at 42. Take me back to the Contents page .9%. with half agreeing that managing data flow between laboratories securely and setting standards for best practice data flow are impacting informatics projects. Joe Liscouski Executive Director at Institute forLaboratory Automation warns.1%. Across the board they appear to have an evenly-spread opinion of the challenges that end users are experiencing.smartlabexchange.” While the Global Business Lead at Pfizer Arnaud Sartre says one of their biggest challenges is grappling with data standards. “One of our biggest challenges is understanding our data standards.com 6 The Top Challenges in Current Projects When looking to the main challenges that end users are currently experiencing in laboratory informatics: we can draw on the following conclusions from the results of the survey: The three main challenges affecting the end user are integrating new technologies at 57. What is our data quality framework? How do we use our various applications? Are we actually using the same terminology across our various platforms?” The vendor market appears to be in the picture of what the end-users’ challenges are apart from they recognise the number one challenge to be streamlining technology used within laboratories at 75%. and reduced likelihood that projects will be successful. increased regulatory burden.www.

Our results show that the most popular investment is likely to be in search systems and data mining over a 12-18 month period.5 1 0.5 Years & Months 2 1. we can share the results of two timelines: medium term investment (6mths to 12mths) and long term (12mths to 18mths). What solutions will you be investing in and within which timeframe 4.5 4 3. looking to our survey results will be in the area of change management and data quality and in accuracies.com 7 Looking ahead to informatics solutions that are most likely to be invested in. The most likely medium term investment.www.5 0 Solution Type Medium term investment (6-12 months) Long term investment (12-18 months) Take me back to the Contents page .5 3 2.smartlabexchange.

with an average of 16-17% across cost.smartlabexchange.00% Looking to factors which are most important when making a decision on buying an informatics solution. does it fit in with a long-term strategy at 50%.com 8 So what information do end users require when looking to invest a new solution? The most popular requirement at just over 70% is references. What factors are most important when making the decision? 17% 50% 16% Does it solve the problem we want to address? Cost Does it fit with our longterm strategy? Is it easy to use? 17% Take me back to the Contents page .00% 60.00% 0. this is followed by history and functionality.www.00% 70.00% 50. ease of use and whether it will actually solve the problem the end user wants to address. both at 57%.00% 30.00% 20.00% 40.00% 10. What information do you need when selecting a service / solution provider? 80.

the way that I would look to do it.smartlabexchange. cost is the main obstacle at 85%.6% Kim Holt. “when budget is a concern. Scientific Manager of Chemistry at South West Water describes how cost may slow their progression despite the company’s ambition and talent.3% Cost Flexibility Priority Support during sign-off 28. is try to get a supplier on board to work closely with. What obstacles do you face getting sign off? 28. while flexibility and receiving support during sign off.” Steven Thomas. Investigator at GlaxoSmithKline adds that expensive software can prohibit how and when equipment is distributed though the company.com 9 When looking at the obstacles that affect the signing off of solutions. both account for over 28% of the reasons of why solutions are not acquired and implemented. we’ve got people who are very passionate and keen to get the products out there.6% 85% 14. “there needs to be a smart way of looking at either low-cost browsers or other web smart interfaces that can allow people access that data for next-to no cost.” Take me back to the Contents page . We haven’t got the cash to spend but we’ve got time.www.

How often do you review your suppliers? 14% 0% 29% Annually Every 0-6 months Every 2-3 years 57% 0% Every 3-5 years Every 5+ years Take me back to the Contents page .www. while 29% said they did so annually.com 10 The SmartLab Exchange also asked the informatics community how often they review suppliers. Over half said they did so every 2-3 years.smartlabexchange.

or say. “It’s our job at GSK to look at the fate of all our molecules in the body so that we understand what the body turns them into to ensure that we don’t have a problem in the clinic with a metabolic liability. We now have the ability to use this data to search from almost any facet so we’re not limited to search by structure. that was done two years ago as it was seen in bile. So. But we took it and in a metabolic world. not just the data. Our colleagues in the US had used a certain brand of software for just storing their analytical data. I can search by mass. Investigator at GSK explains. which allowed us to map data onto biotransformations.com 11 Case Study: Data Cube GlaxoSmithKline recently implemented a piece of software that makes it easier for the user to drill down into the data and search from almost any facet. a lot of our data was on paper for regulatory submission and there was an element of having to know where the answer was before you could go and find it. I can ask for everything that was done in safety species. search and share our knowledge of the metabolites and the outcome. We coined the term “data cube. The Result: Data is far easier to access. Up until recently.” you can turn the face of the cube what you’re interested in and drill down from whichever piece of information you’ve got. your parent can go up to 100 metabolites. We have a lot of information coming through the department that we have to get right quickly so that we can put the best and safest drugs out onto the market and improve peoples’ quality of life.www. I believe ACD had it as a chemist’s tool of A plus B goes to C plus D. It wasn’t really designed for it. We use this knowledge to add to our corporate wisdom.” Take me back to the Contents page . Steve Thomas. analyst or the site. project. getting data to every corner of the company. thus making it available for anybody who can make use of it.smartlabexchange. We want to be able to store. but hadn’t used it to map metabolic outcomes. We have managed to shift the bottleneck to dissemination of that data. so all through the alphabet four times over. we took a look at that over the last couple of years and had a pilot trial that used ACD’s ChemFolder Enterprise.

One of them was having engineers being able to find data when they needed it. When we’re designing dashboards and creating systems we’re always very focused on the decisions that will be made and understanding the information users need to get from any given dashboard. This helps with decision consistency. We needed to be able to compare and contrast data sets from all of these different locations. Instead of focusing necessarily on collecting more data and getting more data integrated into one system. This way a user only has to look at one particular display in order to get enough information to be able to make a decision. Solutions Architect for McLaren Applied Technologies explains the data management solution McLaren built to manage and distil a huge volume of data around racing down into a set of configurable dashboards. so where possible we can actually suggest the action that should be taken based on the data. We try very hard to find ways to translate data into information which can then be used to make a decision. including our headquarters and at the track side. so that if you were looking at a piece of data you would know that it was the latest piece of data and correct. My advice around data management is to make sure you’re getting the most out of the data you do have. so that they don’t have to do any processing in their heads. and not just in pharmaceutical but in all the industries we see. making sure you’re extracting the maximum value from the data you do have is a very good first step and something I’d like to see a lot more people doing. These were some of the challenges we were trying to overcome when producing our system. But actually extracting value from that data is a step that we don’t see many people taking.” Take me back to the Contents page . “We were facing a number of challenges at McLaren. Lots of people have data. We wanted to have one version of the truth. We’ve really focused on understanding the information a user wants to see on a dashboard. and helps the business understand what’s behind any decision that’s been made. We always have the ability to drill down into any aggregated number or data set that you see. We often also try and make the extra step from actionable information to prescriptive information. We bring everything together in the most concise way possible focusing very heavily on visualisation and how best to display that data so that it transmits the most accurate and factual representation of the data. We have data at a number of different sites. knowing exactly where the data was and being able to compare that to any other data sets that they were interested in.com 12 Data Management at McLaren Racing Stephen Rose. or get the understanding they need.www. but does also help to remove some of the ambiguities that can be created when decisions are made Business rules and anything else that’s being taken into consideration when a decision is being made can also be added into the dashboard. but we aim at the highest level to present the minimum amount of information that’s needed for somebody to make a decision.smartlabexchange. there’s a lot of data. This particularly helps in times when you need to make a quick decision.

www. we can reject the results and retest them. It’s only now that we are trying to take a lot of paper-based or previously paper-based systems for auditing and for managing training and even for our consumables’ ordering. Scientific Manager – Chemistry at South West Water explains the informatics system they use. Take me back to the Contents page . which we’re looking to improve. They analyse that water to make sure that it’s safe for people to drink and also ensure that the waste they’re putting out into the rivers is not going to cause any massive contamination. up to 200/300 samples per day and we’ve got to turn these samples around. SmartLab Exchange: What challenges are you facing when it comes to managing your data? K Holt: We do have a lot of data to store. we’re running out of space to actually handle this information and to pull it back quickly enough. One system that we’ve recently introduced. which is dealing with the day-to-day collating of actual sample results.smartlabexchange. SmartLab Exchange: Do you face any integration problems by using various systems? K Holt: We have in some ways but because our LIMS system was very established and was a known quantity we weren’t trying to introduce both of these systems at the same time. production and reporting of those results. The integration works pretty well. our only limitation really is in service base and service speed. the supplier was able to take a lot of our experience with LIMS and integrate quite easily with that system. do a great deal of analysis on it and produce results so that people can take actions out in the field. but it functions absolutely fine. it’s only now that we’re facing those challenges because we were storing this all in hard copy in filing boxes. portable water samples and waste water samples from the whole Southwest region. We had a lot of awareness of the limitations and the abilities of the LIMS system as it currently stands. We’ve put a lot of work into this AqcTools’ package which is what we’ve recently introduced and it’s quite new to the water industry. checks our quality standards and the results from those through producing charts. But we also have other systems that are involved to make sure that the results that we’re producing are accurate. Thermo’s Sample Manager.com 13 Interview: South West Water South West Water laboratories take in water samples. We’re now hitting those problems where not all the systems are talking to each other. can you give me an overview of the work that you’re currently doing at South West Water and the informatic system that’s currently established there? K Holt: We receive hundreds of samples. We have a LIMS system. We report on those charts. so that we can take actions if an instrument is performing badly. We could buy new servers to improve the speed of the integration and speed of the link. Our servers up to this point have been satisfactory. SmartLab Exchange: Firstly. When we went to create the brand new system to handle these products. Kim Holt.

which holds all of it. But again. overall system that takes all of this information and produces a dashboard of sorts. and I think for quite a few of the other people that I speak to. having spoken to other people and seeing some of the innovative solutions that are out there. Can you give any example or any of your own experience on how standards have been set for best practice state? K Holt: Well. again. that’s a difficult question for me in that we have a lot of standards here and we’re highly regulated. The people who are managing those systems would be able to pull back information at the touch of a PC. except when it comes to managing data and managing electronic data. SmartLab Exchange: Having attended the Smart Labs Exchange and having spoken to your peers. having looked at what’s available. not just a laboratory but we could have a South West Water corporate system which handles and makes this consistent across the whole company. particularly. Yes.smartlabexchange. there’s a standard out there for it. We have to manage it but not how we’re supposed to do that.www. selling these ideas to the business as a whole. To have everything going in electronically in a userfriendly single system. that. it is one of our priorities coming up. Every single thing that we actually do on a daily basis. we could have. There are products that are coming out onto the market which do a lot of this work. that would be my driver. another issue we hear a lot of is people talking about the lack of standards in the industry. I think once we’ve got the backing of the people higher up and the decision-makers within the company then that goes a long way to us being able to get further Take me back to the Contents page . And I think that’s a problem because almost the regulations and the standards are lagging behind the technology that’s becoming available.com 14 We’re making inroads with the new package that we’ve put in. But we are very interested in looking for an overarching. how that information is going to be managed is going to be actually one of our challenges over the next two to three years. for me. where do you think the industry is going? K Holt: I think. Will you also consider increasing people’s skills or employing new people to work in the lab? Where will your main focus be? K Holt: If we’ve got these huge ambitions budget is a huge issue to us. Smartlab Exchange: Would you say that this is a primary objective for you between now and 2015? K Holt: It’s becoming increasingly so. SmartLab Exchange: Kim. And it’s actually thinking bigger. but it’s not just water companies that could take on this particular package. would be the ultimate goal. it’s possible in the next five years that this laboratory could be completely paperless. possibly water companies. I also have to put a lot of time and effort into selling this ambition. The way we got round it with developing the AqcTools’ package was we got on board with a particular supplier and really put a lot of hours into helping to create the solution that they could then take to other companies. SmartLab Exchange: Where is your focus going to be in the next three years. my aim.

really. Take me back to the Contents page . we’ve got the skills.www.com 15 down the road. we’ve got the knowledge.smartlabexchange. really. to make things happen. I think we’ve got the people. we just need the backing.

This is where we try and minimise the footprint to get the best of our existing footprint and. at the end of the day. He gave an overview of ways to improve work-flow automation levels in laboratories and advice on how to choose the right vendors. deliver as much business value as possible for our customers. if you look at the various business processes when you work in a global environment. a laboratory level all the way up to enterprise level applications. Pfizer ahead of the 8th Annual SmartLab Exchange event. as opposed to making a lot of manual input in a variety of systems that could lead to discrepancies. In other words. So for us it really is the number one challenge. how do we manage to integrate our various lab informatics solutions that we have from a local level. But one of the key hot topics at the moment is assimilating integration and finding ways to reuse as much existing data as possible. Take me back to the Contents page . around the business analysis of things and how this actually gets applied to our global application.com 16 Interview: Pfizer The SmartLab Exchange caught up with Arnaud Sartre.www. we try to have a core set of applications that actually serves a variety of business lines and purposes. because 55% of our community said they were struggling with this? A Sartre: One of our biggest challenges is understanding our data standards. What is our data quality framework? How do we use our various applications? Are we actually using the same terminology across our various platforms? That sounds very simple. various different work streams. obviously.smartlabexchange. This is done on a project by project basis and is very much controlled through some good levels of training and system access with. when looking at how data flows. SmartLab Exchange: What are the main challenges that you are currently facing working with lab informatics at Pfizer? A Sartre: The number one challenge is really around the data management piece and how to ensure that we generate data once and reuse it multiple times. just internally at Pfizer as well? A Sartre: In terms of the data flow between internal and external parties. but. There are obviously other areas of challenge around maintenance and around global footprints of various applications. a high level of internal oversight. multiple departments. Global Business Lead: LIMs. multiple divisions. SmartLab Exchange: How do you ensure a secure data flow between internal and external parties and. indeed. Internally. SmartLab Exchange: How do you manage secure data. we do have some systems that may be open to some of our partners. you realise very quickly that a lot of people are talking about the same thing in completely different ways.

what is the end business goal? Is the business goal to just generate data? Is the business goal to generate knowledge? Is it intermediate? Is it about generating information? Or maybe it's a bit of all three. The other element is around how the system is really performing. could you share some ways of improving workflow automation levels in labs? 17 A Sartre: Workflow automation at a lab level starts from the ground up so we really need to have our key stakeholder and laboratory colleagues understand what we are trying to achieve. Obviously the technology aspect is one element. at the end of day. at the end of the day all of these various systems actually allow us to do a lot of things. We can have a lot of systems. different systems to all sorts of different things. a CDS. SmartLab Exchange: Are you saying budgets really affect the overall decision-making or are there any other factors which become obstacles when moving forward with new technology? A Sartre: I've not been directly involved in this decision in the recent past. SDMS. but also technical abilities and merits.smartlabexchange. how do you select the right vendors to work with and what factors are most important when making the decision of investing in technology? A Sartre: Obviously cost is a big element. but really at the end of the day it's finding the right balance between meeting a business need as well as working within a constrained budget. The real question is around what are we actually achieving or trying to achieve? I sometimes like to start from the end. I would say that cost is one element. SmartLab Exchange: I know that you have an ELN and a LIMs system in place. What sort of business solutions has been provided to other customers and are we likely to benefit. it's about understanding the best system that we can get to meet the business need and meet the internal constraints of cost. we can have a LIMS. it is very much around defining what the end business goal is. Various vendors provide a tremendous range of capabilities. about knowledge and this is really where you have to start thinking around the overall lab informatics platform and how the various systems actually interface with each other in a very meaningful fashion. without necessarily seeing an overarching definition and answer to the question of what's in it for me at the lab level. SmartLab Exchange: What changes do you expect to see within the next five years that will have an impact on lab informatics? A Sartre: I have this vision of a fully integrated lab and I really think that we are on the brink of actually seeing this becoming a reality. there are a variety of cost structures. it is certainly not the only element.com SmartLab Exchange: From your own experience. Beyond. ELN. Mainly.www. From my own experience I have often seen very good systems and new processes being implemented to a variety of laboratories. but I'm also starting to see a lot of vendors moving into platforms that allow customers to perform a lot Take me back to the Contents page . It may be about generating data that leads you to information and.

new platforms and systems.com 18 of things in a very similar fashion. SmartLab Exchange: What industries are you looking forward to hearing from at the SmartLab Exchange this year? A Sartre: Primarily. the answer might be yes.www. but there is definitely some very good headway into that direction. from our peer group: the pharmaceutical industry. And the platform is really the key. I think we are moving away from the system-specific to a more platform-like where the various lab informatics solutiona actually become more modularised and the labs.smartlabexchange. But I think ultimately the key point for me is how to actually benefit from these new technologies. the answer might be no. I'd personally welcome any other industry just to broaden the horizon and try and understand what other industries are actually doing because I'm sure there is a lot of very good work happening in different industries around very similar topics that the pharma world is interested in. Do we need to re-evaluate our technology solution. Take me back to the Contents page . but really it's about achieving a fully integrated lab. I'm not going to get into the detail of which vendors. There are obviously a lot of questions pending these changes. time will tell. what solutions. pick and mix different types of solutions that may have been presented before in various software suites. in some ways.

Could you give us some clear reasons as to why this is? M Shields Uehling: Identity trust is the fundamental issue in electronic systems -. faxing. Business processes are struggling to keep up with electronic communications. President & CEO.smartlabexchange. This transformation is made possible because digital signatures. Paper-related processes like scanning. SmartLab Exchange: Digital versus electronic signatures at SAFE Bio-Pharma. reducing time and costs and can be used globally. and the signature meets regulatory requirements in all leading regulatory jurisdictions. The digital signature is replacing the wet signature in all organisations. It might be as simple as a faxed version of a wet signature.creating the document electronically. and exchanging it electronically. If a digitally signed document is changed. We need to focus on full electronic immersion -. the viewer knows it immediately because the signature is invalidated. they can be validated at any time now or in the future. unlike common “electronic signatures.” are uniquely linked algorithmically to the individual’s proven identity. Unfortunately. modifying it electronically. The signature is legally enforceable in the world’s major jurisdictions. SmartLab Exchange: The development of secure digital signatures obviously has been critical to the adoption of informatics systems. signing it electronically. This assures that the identity of the person behind the signature can be trusted. Digital signatures remove the vulnerability by linking the signer’s proven identity to the signature. and courier use no longer cut it. Safe Bio-Pharma Association explains. Digital signatures are also persistent. email attachments. what are the benefits of digital signatures? M Shields-Uehling: Using digital signatures is transformative. This is extremely important in protecting intellectual property. Common electronic signatures simply don’t provide sustainable levels of protection.com 19 Interview: Adapting Digital Signatures into your Organisation The world is becoming an electronic landscape and businesses are no longer paper-based. You may never know that an electronically signed document had been changed. consequently. are transitioning the bio-pharmaceutical and healthcare community to fully electronic communities. The laboratory. more efficient and more productive. There are additional advantages to digital signatures.www. SmartLab Exchange: So what is the difference between an electronic signature and a digital signature? M Shields-Uehling: Common electronic signatures are vulnerable because there is no identity linkage. Businesses become fully electronic and. regulatory body or court of law doesn’t know whether or not the signatory actually applied the signature. Mollie Shields-Uehling.the assurance that you can trust the identities of those accessing your sensitive information. Take me back to the Contents page .

It makes the process fully electronic and provides much more rigour in terms of defending patents and other challenges. universal. telecommunications. chemical lab notebooks. And there are similar efforts underway that will result in being able to trust different digital identities across Europe. Some 400. and bio books. They are being utilized in multiple industries and by the US federal government. portable identity and digital signature that can be used with all partners across multiple systems. This exists between SAFE-BioPharma and US Government agencies. aerospace and defence. The European Medicines Agency and the FDA have publicly stated that they’re on path to fully electronic receipt. we should strive for universal identities that are interoperable with multiple information systems. review and respond systems. In the United States we see huge use of SAFE-BioPharma digital signatures associated with electronic prescribing of controlled substances. they’re used in financial services. and submit their background information. The greatest growth of SAFE-BioPharma digital identities and signatures is in the area of collaboration. Most organizations require a separate identity for anyone entering their enterprise.000 prescribers now in the process of receiving digital identity credentials that are compliant with the SAFE-BioPharma standard.smartlabexchange. Instead. we'll see all clinical data signed and submitted electronically.com 20 business is applying industrial era policies to the information age. External partners. SmartLab Exchange: Have you any case studies that you could share with us of an organisation that has adopted digital signatures and perhaps discuss the challenges they overcame? M Shields Uehling: Digital signatures are used extensively to sign electronic lab notebooks. they can sign anywhere in the world if they have internet access. sign their contracts. There have been hundreds of thousands. particularly clinical investigators authenticate into websites to gain access to clinical trial documents. Scientists no longer have to hold signing parties. In the future. We're seeing the initial cases of that today. Users need only one digital identity to deal with multiple sponsors. if not millions of regulatory submissions to the FDA using digital signatures. Among others. multiple regulatory agencies and to conduct all of their work in the cloud.www. SmartLab Exchange: Can these signatories be used or adapted to other industries? M Shields Uehling: Digital signatures are about productivity improvement and cycle time reduction. There are initiatives to make all of these identities interoperable – meaning broader bilateral trust of digital identities between multiple enterprises.. and atomic energy. Take me back to the Contents page . The Drug Enforcement Administration requires a strong level of trust in a digital signature related to electronic prescribing of controlled substances. The SAFE-BioPharma digital identity standard supports – a single. Regulatory document management systems have adapted to support the SAFE-BioPharma standard.

000 patients enrolled and they have multiple. they’re signed. scanning. using the signing application. At any given time they have 800 to 900 trials underway. SmartLab Exchange: What are you looking forward to most at this year's SmartLab Exchange event? M Shields Uehling: I’m looking forward to discussing the success of SAFE-BioPharma member companies using interoperable digital identities to move business and research collaboration to the cloud. indeed. This process is possible because the SAFE-BioPharma digital identity credentials used by the company researchers are interoperable with the government identity credentials used by the NCI researchers. The process allows the National Cancer Institute to reduce the amount of time and cost to start a study. etc. multiple partners.com 21 SmartLab Exchange: I understand that you will be speaking about the National Cancer Institute and research partners at the SmartLab Exchange and their use of identities. both in academia and in private practice. Once signed. There is bilateral identity trust. NCI is now moving into production with this application and will expand it to a variety of business processes. They have some 33. signatures and.smartlabexchange. sponsors. submitted and exchanged before a study starts. Among the hard costs NCI eliminated are couriers. Can you elaborate a little bit more on the work that they're doing? M Shields Uehling: The National Cancer Institute is the largest conductor of clinical trials in the world. NCI has an elaborate study initiation process whereby many documents have to be signed. NCI saved 2.www. Although they have not yet calculated personnel costs for those and other functions. in the cloud where. the signing app notifies the originator and the document is taken off the signing app and executed.2 hours for every transaction and for every wet signature that was replaced by digital signature. photocopying. cloud computing to accelerate their drug development. SAFE-BioPharma and the National Cancer Institute have been using a signing application that allows NCI researchers and their private sector counterparts (in this case from Sanofi and Bristol-Myers Squibb) to put trial start-up documents. Take me back to the Contents page . major pharmaceutical companies and small companies as well as many clinical researchers.

QC and Principal Scientists choose which solution providers they will be investing in over the next 12 months? We surveyed our international network of data management and lab informatics professionals to find out which solutions they will be investing in. Head of Biologics Research Informatics .www. Scientific Data Analyst. Array BioPharma Array Biopharma was one of the first pharmaceutical organisations to implement an ELN 11 years ago. Roche Ralph Haffner. Cat Andersen and the team at Array have been instrumental to ensuring its success. Listen Now Get help solving this challenge INTERVIEW Accelerating Discovery by Enhancing Data and Information Integration With Ralph Haffner. Head of Biologics Research Informatics at Roche. about the secret behind a successful integration with an existing informatics systems. followed by a lightweight LIMS. spoke to Andrea Charles.com 22 Additional Resources INTERVIEW Array’s ELN: Maturing into the Teenage Years With Cat Andersen . the advantages and disadvantages of customisation and looks ahead to the next 5 years. Listen Now Get help solving this challenge INFOGRAPHIC Building a SmartLab & Optimising Efficiency in 2013 Ever wondered how CIOs. QA. She spoke to the Exchange team. to help them achieve an efficient lab in the most cost-effective manner View Now Get help solving this challenge Take me back to the Contents page . about the challenges of achieving seamless integration between ELNs. interoperability and collaboration. LIMS and other IM systems and how the industry is addressing these challenges to achieve better integration. Global/Regional Heads of R&D.smartlabexchange.

please contact us: Telephone: +44 (0)207 368 9484 Email: exchangeinfo@iqpc. Niamh’s journalistic career began in Ireland where she worked for the National Broadcaster.com 23 About The Exchange The SmartLab Exchange Network is an invitation only forum designed to help senior strategy makers overcome their most pressing challenges. Exchange only invites CIOs and Laboratory Informatics executives with the highest credentials. and solution providers with the most cutting edge capabilities. to deliver a unique business development opportunity and true peer-to-peer learning and networking forum.smartlabexchange. Niamh has used her combined experience as journalist and events manager to produce and host online learning forums such as webinars and Online conferences for IQPC.com About the Author Niamh Madigan is Editor of Pharma IQ . If you would like more information about the Exchange. as a Television Producer on current affairs and health programmes for 5 years.smartlabexchange. RTE.com Website: www.www. She holds a BA (Hons) in Media Studies and a First PostGraduate Diploma in Journalism. Take me back to the Contents page .

FMCG. You will have the unique opportunity to learn. please call +44 (0)207 368 9484 or email exchangeinfo@iqpc.com . healthcare. please call +44 (0)207 368 9500 or email exchangeinfo@iqpc. pharmaceutical and biotech industries? The 8th Annual SmartLab Exchange will take place 26 .smartlabexchange. Hilton Munich Want to find out more? Are you interested in exploring the themes of this report in greater depth with Director-level representatives from food & beverage. if you are a solution provider and want to find out how you can join the event. cosmetics. network and find solutions to some of your biggest challenges by joining innovative solution providers and the most senior decision makers at the Exchange. Germany.com Alternatively.com www.27 February 2013 in Munich. For more information about requesting an invitation to attend SmartLab Exchange 2013. to discuss how the largest of smart laboratory and informatics projects can be fully realised. petrochemical. oil & gas.8 26 .27 February 2013.