Lori McKellar

Lori McKellar

Three Pillars of Digital Transformation – Efficiency, Usability and Insight

Digital transformation

In my previous blog, It’s Not About the Pill. It’s About the Patient, I asked if digital transformation was just a buzzword and if not, what did it mean? I talked about leveraging both existing and real-time information to gain insight, make better decisions, unify and speed key business processes and to engage with customers in a way that drives business value and customer loyalty. At our recent Customer.Next event I gave customers a quick peek at the newest release of the Documentum for Life Sciences solution suite, which is now available. In this release, the four major areas of enhancements were all focused on three things – efficiency, usability and insight. Why? Because to transform, companies need to set a solid foundation for driving process efficiency, ensure that workers can easily get their jobs done and derive actionable insight to help make informed decisions, allocate resources and continuously improve. These three things are foundational “pillars” of digital transformation. Let’s take a closer look…. Pillar #1 – Driving Process Efficiency Life Sciences organizations are tasked with maximizing efficiency across the full drug lifecycle. Bringing safe, high-quality drugs to market faster at a lower cost requires unifying processes that extend across domains, divisions and external partners. It requires the ability to link and seamlessly share documentation—the critical element inherent throughout the drug lifecycle. Unfortunately, what we often see is organizations who are managing a myriad of disjointed systems, often gained as a result of mergers and acquisitions. Many are custom applications designed for specific departmental needs. In this situation, companies can benefit from asking themselves a couple of questions: Why introduce unnecessary complexity, inaccuracies and risk to business processes by exporting and importing content from one system to another? How do you rationalize the data models of each system to help unify processes across systems, eliminate duplicate data entry and ensure overall data accuracy and completeness? In our new release, we are driving process efficiency in a new segment of life sciences. Many of our pharmaceutical customers also market medical devices as part of their portfolio. Yet, because of a lack of formal, regulatory requirements related to electronic submission requirements for medical devices, many of our customers were managing their medical device documentation outside of an electronic document management solution (EDMS.) The process was largely paper-based. Therefore, to drive process efficiency, we now provide a single, cohesive solution that manages quality and regulatory documentation for both medical devices and pharmaceuticals simultaneously. With a global, standard document inventory and processes harmonized across the regulatory and manufacturing domains, we can now support the full medical device documentation lifecycle from design to production manufacturing. And because of the ability to seamlessly link and share information across domains, it helps unify and automate the process to drive efficiency, accuracy and better visibility. Pillar #2 – Improving Usability Another foundational pillar of digital transformation is to make it simple and straightforward for workers to access the information they need and to easily get their work done. Workers expect easy-to-use, consumer-like mobile applications that they can access on their phones and tablets to ensure that work continues even when they’re on the go. But of course, all actions must still conform to compliance requirements. To summarize, in today’s world, solutions have to be designed for people, not power users. The first example of how the Documentum Life Sciences solution suite addresses this may cause a bit of a flashback. Why? Because I’m going to talk about controlled print. Yes, that’s right – controlled printing in the quality and manufacturing area. But controlled print has been around for ages, you say, right? It has. But that doesn’t mean something like this can’t “transform” as well. We’re continuing to meet compliance requirements but we’re doing it in a more flexible and user friendly way. Trust me; this was an unexpected hot button among our customers. For example, wouldn’t it be easier to be able to set up a series of print profiles so that when someone needed to print a standard type of document, it automatically knows what watermarks, overlays and metadata needs to be applied? Or perhaps, the process of having to select a printer, select each recipient and print controlled copies one by one, repeating that process over and over hasn’t been “efficient” when it comes to getting the job done quickly? I don’t want to give too much away but you need to check this out. Another improvement we’ve made to make it easier for workers is enhancing our document inventory to ensure alignment with industry/regional guidance across the globe. While we adhere to the DIA Reference Models and other industry guidance, we’ve expanded on these to ensure that our inventory supports global quality, clinical trial, and regulatory document types. Users can filter by region and select from a pre-defined list of document types to speed operations and make it simple to get the job done. Pillar #3 – Delivering Actionable Insight The final pillar that I’ll mention is the need to gain insight to help organizations focus resources and make quicker, better informed decisions. With Life Sciences’ ever-present goal of accelerating time to market, being able to quickly get a status or understand key metrics and trends is increasingly valuable. Documentum Electronic Trial Master File (eTMF) was significantly enhanced to help provide insight into the clinical trial process and collection of required documentation. Granular level milestones at the country and site level reflect what TMF documentation is required, what’s missing and what’s completed based not only on the trial status but also as countries and sites progress through their individual milestones. If a site is not yet initiated, document collection requirements would not appear. Similarly, if a country has not given approval to conduct a trial, document placeholders would not appear. However, when those milestones are met, the placeholders appear. This granularity allows managers to focus on exactly what is needed at a specific point in time. And, with quick color-coding and icons, they can quickly grasp where the trouble spots are. Similarly, new trend reporting helps identify which sites are consistently late in submitting documentation, which documents routinely fail the quality checks etc. By having tangible metrics and trend reports, companies can focus stretched resources to where the need is greatest to address the issues and boost overall efficiency and productivity. Three Pillars and Three Questions As I said in the beginning, digital transformation is about managing information as a strategic asset. It’s about leveraging both existing and real-time information to gain insight, make better decisions, unify and speed key business processes and to engage with customers in a way that drives business value and customer loyalty. Efficiency, Usability and Insight are three foundational pillars that help support and drive digital transformation. Hopefully, you also have a better understanding of how the Documentum for Life Sciences solution suite and its new enhancements can help support your transformation objectives. Now that I’ve shared some thoughts with you, I’d like you to share some thoughts with me. Is there a specific process or area that your company is targeting to improve efficiency? What do you expect in terms of “usability?” What do descriptors like simple, easy and intuitive mean to you? What do you wish you could have more insight into? Are there areas where you would like more quantifiable metrics? What role are analytics playing in your organization?

Read More

It’s Not About the Pill. It’s About the Patient

digital transformation

“Digital transformation”is one of today’s common buzzwords. What does that really mean? After all, in the content management world, we’ve been digitizing paper and automating business processes for years. So, what’s new? We know that digital transformation is about business strategy , not just technology. We’ve all seen the examples of “disruptive business models” like Uber, Amazon and Airbnb. Great, but they all used digital mediums to engage with the customers and provide a better customer experience. So, if technology does matter, where does it fit in? Today’s digital transformation is about connecting the dots and it’s based on content that is available throughout the organization and beyond. It’s about moving away from paper-based decision making to real-time decision making. It’s about leveraging both existing and real-time information to gain insight, make better decisions and to engage with customers in a way that drives business value and customer loyalty. So I was curious—what does digital transformation mean in Life Sciences today? Patents are expiring, competition is intense, and organizations are compelled to continually speed time-to-market for new medicines. Organizational responses vary, but most are adopting new business models, expanding globally, entering into alliances and partnerships, outsourcing, pursuing acquisitions—or all of these. Companies are executing on these initiatives against a backdrop of regulations and government reforms that are not only in a state of constant flux, but shift from one market to the next. How do organizations that are dealing with all these challenges, transform? It comes down to a single focus, the patient. The business strategy needs to shift to put the patient at the center of everything an organization does. It’s no longer about the pill, device, or medicine. It’s about Life Sciences organizations orienting themselves to bring safe, high-quality drugs to market faster at a lower cost. But that’s not all. It’s also about engaging with and educating doctors, patients, their families and caregivers to improve health and well-being in material ways. It’s not about the pill. It’s about the patient. Let’s look at three ways companies are shifting their focus and embracing technology to help drive transformation. 1. Patient Outcomes: According to McKinsey, “Payors and governments have an ever sharper focus on managing costs while delivering improved patient outcomes, putting an even greater onus on pharmaceutical companies to demonstrate the value of their drugs in the real world – not just in randomized controlled trials – if they are to retain market access and premium pricing.” The CEO of Novartis, sums it up well in this article where he says that companies must shift from a transactional approach to an outcomes-based approach. “Transactional means, for example, just selling a pill. An outcome approach focuses on delivering a positive patient outcome, of which that pill is one piece.” 2. Patient Monitoring: For Life Sciences companies to prove real-world health improvements, technology can be leveraged to gain insight. “…digitally enabled, ‘beyond the pill’ solutions, which include not only drugs but also sensors to collect and analyze data to monitor a patient’s condition between visits to healthcare providers. These are becoming critical to serving both parties’ needs. Such solutions drive the adherence to treatment and outcomes that payors and governments seek, and they generate the data that pharma companies need to demonstrate their drugs’ superior efficacy.” 3. Patient Engagement: Today, access to information is easily available. We can search out information at home and from our laptops, tablets and phones. Who among us hasn’t searched for health information on sites like WebMD at one time or another? In one survey, more than 85 percent of patient said they were confident in their ability to take responsibility for their health and knew how to access online resources to help them do so. Because of this, Life Sciences companies are expanding their use of websites to communicate information and engage with patients via chat and callback features. They are also embracing social media to engage and drive both peer-to-peer communication and communication between doctors and patients. These three things are just the start of what digital transformation means in Life Sciences. Today, Life Sciences organizations must find new ways to identify, prioritize and develop promising therapies more quickly; to leverage their existing (and rapidly growing) data to derive meaningful insight; and to maximize efficiency across the full drug lifecycle. They must also engage and communicate with patients, doctors and others to enable them to treat the whole patient and drive better outcomes. In short, it requires a business transformation that parallels the radical changes in the industry.

Read More

On the Journey to the Cloud, Choice Matters!


Whether your organization is a 25-person biotech startup or a billion-dollar global pharmaceutical company, you face the same critical challenges that impact your business every day: reducing risk, speeding time to market and ensuring compliance. For smaller organizations, it’s a challenge because IT systems designed to help in these areas have traditionally been out of reach – either due to high investment costs, resource requirements or a combination of both. Unfortunately, the lack of content management systems to support these critical processes can lead to insufficient control of documentation and time-consuming, manual processes that result in errors, delays and increased risk of non-compliance. For larger organizations, it’s still a challenge but for different reasons. Many companies have customized content management systems in place. While custom-tailored solutions certainly met the organization’s needs at one time, they usually hinder the kind of agility that companies need today. Alternatively, some organizations have a mix-and-match infrastructure of departmental solutions – once best of breed, but now outdated. The ability to harmonize and share data across these systems to unify key business processes and drive efficiency is a very tall order. Yet others maintain multiple and often duplicate systems resulting from mergers and acquisitions. Regardless of what the infrastructure footprint looks like, the cost to maintain these systems often takes a big bite out of limited IT budgets. At the intersection where some companies need to get up and running quickly, with minimal IT resources at a lower cost while others need to improve agility, and reduce maintenance costs while (often) preserving existing investments, we have cloud technology. Typically, the word “cloud” brings up all sorts of different definitions.  And that’s okay. Cloud technology is not a “one size fits all” paradigm. At least it shouldn’t be. Today, Life Sciences companies of all sizes are looking to maximize their resources and budgets in a way that enables innovation, seamless business processes and quick responses to changing business needs. At the same time, they need to meet their security, privacy and control requirements at an affordable price. Because of this, different companies will have different needs. The priorities for a smaller company may be to leverage a hosted solution reflecting industry best practices to get up and running quickly, with minimal IT overhead and an all-in-one subscription-based price. A larger organization may prefer to leverage both public and private cloud solutions in various parts of the business. Others may prefer a managed service to help offload management of their existing on-premise systems yet preserve their current investments. The main point is that each company has its own unique IT landscape in place, and each company is unique in its resource availability, risk tolerance and overall objectives. This is why the Documentum for Life Sciences solution suite gives you choices. Need a hosted cloud solution that your partners can access from almost anywhere? We’ve got that. Need external accessibility in the sales and marketing area but prefer to keep your R&D information in a private cloud? We’ve got that. Trust your Documentum system, but want someone else to deal with the upgrades, patches and migrations? Done! Today’s environment calls for choice. Choice is what will allow organizations to successfully make the journey from where they are today to where they want to be tomorrow in the most efficient, simplest and cost-effective way. The right choice for one won’t be the right choice for all. Whether your organization is looking for its first content management solution to get that first submission out the door, to position your company for expansion and growth, or to deliver next-generation solutions while preserving (or even streamlining) your current content management footprint, we’ve got you covered. And we’re here to help.

Read More

Close Collaboration: An Essential Ingredient in Life Sciences


I think most of us would agree that it’s great to be part of a team that collaborates and genuinely gets along. But collaboration is not only good for morale; it is good for business. Research by McKinsey indicates that companies with better collaboration capabilities achieve superior financial performance. But the truth is that making collaboration across functions a reality is a challenge. From a Life Sciences perspective, how do companies share information, ensure accuracy, work with regulators and expedite handoffs—that is, collaborate—to achieve the ultimate goal of getting a drug to market efficiently? This complex process involves so many people, in so many areas of the business and with so many partners—how can collaboration be facilitated and sustained? One angle to consider is the role that content plays in driving collaboration. After all, content is associated with the drug starting at discovery and stays with it throughout its lifecycle. This goal, enabling collaboration on content, is at the very heart of the Documentum for Life Sciences solution suite. Let’s take a look at how this collaboration happens by taking a simple, high-level, but illustrative “day in the life” view of the end-to-end process to see who does what and how. Maybe you’ll walk away with a new perspective and some ideas on how collaboration can help drive efficiency and streamline content development across your organization. “Day One” — Clinical With every new discovery comes documentation (i.e. content.) From inception, life sciences companies are documenting their discoveries and filing investigative new drug (IND) applications for permission to conduct clinical trials. During clinical trials, there are strict requirements for many types of documentation—from the curriculum vitae of the doctors involved to the trial protocol and informed consent form, to name just a few. Literally hundreds of documents are involved, many contained in the Trial Master File. The beauty of Documentum Electronic Trial Master File (Documentum eTMF) is the ability to help sponsors and Investigators share and collaborate on critical clinical content. Using the investigator portal in the eTMF solution, these documents when submitted are automatically posted in the right place within the TMF for fast and easy access. Leveraging standard reference models, Documentum eTMF facilitates collaboration and management with accurate, consistent and complete documentation. Equally important, Documentum eTMF makes it easy to collect, share and provide access to trial documentation between sponsors, clinical research organizations (CROs) and sites. By integrating compliance and security models and enabling controlled access, it facilitates safe information sharing across the extended enterprise and ensures that people see only what’s relevant to them. Additionally, the ability to collaborate electronically reduces the time required for the review, update and finalization of content. “Day 2” — Research and Development Now let’s move to the research and development (R&D) phase. I should note that typically, a number of cross-over documents contained in the Trial Master File must also be available to Regulatory staff compiling the submission. In short, Documentum for Life Sciences solutions enable seamless sharing of these documents from one functional area to the other—a single source of the truth, eliminating version control and traceability issues. It’s within R&D where collaboration is perhaps most critical: using collaborative authoring to expedite the review and approval process. Documentum Research and Development (Documentum R&D) encompasses workflow-driven collaborative authoring tools for simultaneous editing. Multiple contributors can edit and annotate a document simultaneously—and the system automatically merges the changes. The primary author has access to a single copy of a document with all participants’ input, and then can review, accept or reject edits as appropriate. Further, the solution enables seamless information sharing and bidirectional communications between the sponsor’s headquarters and local affiliates. With a single authoritative source, sponsors have confidence in the accuracy of the data submitted to health authorities. Affiliates, in turn, have access to approved information, with the flexibility to adapt content to meet local requirements as needed. “Day 3” — Quality and Manufacturing Finally, once the application is approved, all documentation must be shared with quality and manufacturing, where a new set of compliance requirements come into play. Many types of documents originate in the R&D realm, but must be transferred to commercial production as scale-up and knowledge transfer activities are initiated. Documentum Quality and Manufacturing (Documentum Q&M) enables that seamless transfer of content and provides traceability between the original content and new, GMP as well as GxP – compliant quality documentation. Furthermore, proactive notifications between both Regulatory and Quality stakeholders ensure that any change to a quality /manufacturing document can be quickly assessed for the potential regulatory impact. Finally, Documentum Q&M supports “to be read and understood” tracking and reporting for instances where documents such as a batch record or manufacturing SOP require pre-processing/training before execution, and automatic distribution of key documents such as standard operating procedures to team members as required further ensuring communication and collaboration. I hope this “day-in-a-life” glimpse has provided some insight into how a focus on content can be an enabler to help drive collaboration and communication and boost efficiency in key business processes. Hundreds of documents, countless people working together across multiple boundaries over thousands of days: that’s why content collaboration as well as integrated communication is an essential element of the drug development lifecycle. By breaking down functional silos, enabling content collaboration between key stakeholders, and fostering clear and ongoing communication between them, productivity and performance can be improved.

Read More

Regulatory Information Management – Where are you on the Journey?

Regulatory Information Management

Life Sciences companies are under pressure to reduce the costs of regulatory operations and speed up health agency approval to accelerate time to market. However, this is no easy task! Each organization is in a unique place on the Regulatory Information Management (RIM) continuum – some need to put a foundational content management system in place, others are trying to unify processes with affiliates or shrink their dependency on spreadsheets and yet, others are trying to rationalize myriad and duplicative systems to streamline processes and drive down costs. Fortunately, I have a bevy of regulatory experts ready to share their knowledge and experience to help you meet your RIM goals regardless of where your company falls on the continuum. Regulatory Information Management is Complex! First, the regulatory landscape is complex and always changing so just keeping up with regulatory requirements across global markets is challenging. Second, organizations are often in varying degrees of maturity when it comes to regulatory processes. Some organizations do not have a content management system in place to help manage all their controlled documentation including how documents are created, reviewed, approved, trained on, distributed for use, revised and retired. On the other end of the spectrum, some companies manage multiple content management systems and are striving to rationalize them in a way that streamlines operations and reduces costs yet ensures information accessibility and compliance. For most companies, regulatory processes span a myriad of disjointed systems and processes. Operational complexity reigns and accessibility and usability are problematic. Due to these challenges, regulatory organizations struggle to efficiently submit to regulatory agencies. They struggle to know which of their products are registered in specific markets. Sponsors often lack visibility into the exact contents of submissions within each country or region. And keeping track of agency interactions brings yet another collection of systems and applications into the mix. Changes clearly need to happen to achieve the goal of accelerating time to market when it comes to RIM.  Life Sciences organizations must improve efficiency and productivity, as well as, data quality, accuracy and compliance. Where Do I Start? If your company is one that doesn’t currently have a content management system in place, let’s look at two fundamental capabilities outlined by Gens and Associates in their Drug Information Association (DIA) presentation, “Measuring and Achieving World Class RIM”, that companies must do very efficiently when pursuing an effective (and world class) RIM strategy. R&D Document Management: Organizations must have a streamlined process for the creation, review and management of submission documentation. By leveraging industry-standard dictionaries, taxonomies and object models combined with a template-based authoring process and collaborative review process, the speed, accuracy and completeness of submission-ready documentation can be improved. Documentum Research and Development  helps ensure the efficient creation of accurate and complete submission documentation. Health Authority Interactions (Q&A, correspondence): On-going communications with Health Authorities continue throughout the drug lifecycle. Organizations need easy access to regulatory submissions and the associated regulatory correspondence to enable a complete view of regulatory activity. Submission Store and View simplifies the search and retrieval of archived submissions and their associated correspondence, while improving security and compliance. The solution links regulatory correspondence and communications to submission files, enabling a full view of regulatory activity within a scalable, secure Documentum repository. If your organization falls into the second camp where you are trying to rationalize multiple and often duplicative systems, let’s look at another key consideration – the need for a single source of truth for regulated content. While most Life Sciences organizations operate in silos; content follows the lifecycle of the drug. Therefore, having a single authoritative source across all functional areas breaks down information silos and enables documents in one domain to be used by key stakeholders in another. This approach minimizes discrepancies and uncontrolled copies, ensuring that information is accurate, timely and accessible. Organizations can respond faster to product changes, compliance concerns or health authority requests. How Can I Ensure Success? Regardless of where you are in terms of your Regulatory Information Management initiatives, there is certainly lots to figure out. RIM is not easy but it’s essential to driving more efficient regulatory processes and accelerating time to market. Where does your company fall on the RIM continuum? What challenges are your experiencing that we can help you with? Do you have some best practices to share based on your own success? Read more on Life Sciences and how we are helping here.

Read More

Leaping With Joy in Life Sciences


There is a well-known quote by Sir Arthur C. Clark that says, “Any sufficiently advanced technology is equivalent to magic.” It’s pretty amazing when you get to see technology that has the power to completely change the game. For those of you who were lucky enough to attend our recent Momentum Conference or follow the announcements, you may have heard about the suite of cloud-native content apps called LEAP that we introduced there. LEAP consists of both ECD and third-party content apps, a modular platform, and a marketplace. These apps are interoperable with existing content repositories and are engineered to work with the Documentum family of content management products. As we know, Life Sciences is an industry where compliance has historically been a dominant driver when making decisions about technology and content-related business applications. And, it wasn’t uncommon for business users to be told that things needed to be done a certain way for compliance reasons. Over time, we’ve seen how easy to use apps in our personal lives has led us to question why we can’t have a similar, intuitive experience with our work applications. Liberate the User Today, we want that same consumer-like experience when working with key applications in the workplace. And, we want to access those applications on multiple devices  desktops, laptops, tablets, and mobile phones. This is why I am so excited about these five apps, for the business users, they are like magic. Let’s look at each of them and how they have the power to transform the user experience in Life Sciences. LEAP Courier:  Content exchange without the chaos Courier allows secure and structured document exchange, validation and tracking. I can think of all sorts of use cases in Life Sciences. In clinical, an Investigator Portal can facilitate the exchange of key study documents between Sponsors or CROs and Investigators. Similarly, a Regulatory Affiliate Portal can enable the distribution of a core submission dossier to global regulatory offices and enable the collection of regional specific submissions. LEAP Snap: Enterprise-class capture made for everyone Snap allows anyone to quickly digitize, organize and convert documents to data to automate your business. Expanding on the use of Courier in clinical to exchange key study documents, Snap can allow documents from Investigator Sites to be scanned and uploaded. In Quality and Manufacturing, it can be used to capture Executed Batch Records and other hard copy files on the manufacturing floor. LEAP Express: Anywhere, anytime access to your content Express allows you to quickly access, review and approve all your content, no matter where it lives. Imagine being able to provide your team with an app that requires minimal training and allows them to quickly access, review and approve documents from anywhere, eliminating delays. I am sure that teams working on documents required for regulatory submissions could benefit given how critical time to market is. Teams working on standard operating procedures (SOPs) can also benefit. Really, any person in the industry who needs to access their content to review or approve will benefit – there are too many examples to list! LEAP Concert: Collaborative authoring with content Concert enables document creation in a collaborative and controlled environment. Documents can be easily divided and workflows applied, while controls prevent unauthorized content changes. Referring back to the regulatory submissions process, how great would it be to be able to easily assign sections of a document to different people to work on and enable collaboration from a mobile app on the go? LEAP Focus: Optimized content viewing designed for mobile Focus improves document content consumption on mobile devices. It replaces pinching and zooming with a user experience that’s perfect for whatever device you use. The Life Sciences industry is no different than others in the need to be able to view contracts, agreements and other documents on multiple types of devices in a clear, straightforward way. Maximize the value of your existing investments For business users, the time has come to be liberated from cumbersome “because we need to be compliant” experiences. Not a fan of training? These applications are intuitive and require minimal training. Don’t like to read the manual? Forget about it. The time has come to move from complex to simple. This is true both for the business user and IT. In Life Sciences, the Documentum content management platform is proven, trusted  and prevalent. And the Documentum for Life Sciences solution suite is seeing strong adoption. With Leap, companies can avoid the cost and time of migration by leveraging the existing Documentum platform while providing modern, purpose-built Life Sciences solutions with the simple, user experience that people expect from cloud-based applications. This can all be accomplished while still balancing the ever-present need for control and compliance. It’s the best of both worlds, they are better together and it’s magical!

Read More

Are Life Sciences Organizations Ready for Business Transformation? The Returns Are In

Life sciences

The pressure is on for Life Sciences organizations to transform by accelerating time-to-market and improving efficiencies enterprise-wide. The word from the executive suite: reduce operational complexity, improve productivity and repurpose headcount to higher-skilled activities. Are organizations responding? The answer is a resounding yes. Multinationals and midsize companies alike are beginning to adopt business-specific solutions for regulated content management in large numbers to help them accomplish these critical objectives. And, we are pleased to report, many of them are adopting solutions from the Documentum for Life Sciences Solution Suite. In fact, we’ve experienced 6X solution growth over the past 3 years. Some customers are choosing individual solutions, while others are adopting the entire suite. I had a chance to speak with the head of U.S. sales for Life Sciences industry solutions at Enterprise Content Division, to get his perspective on what’s driving this growth. Question: What’s happening in the industry that’s driving the demand for our solutions? There are many reasons, but what we’re hearing most often is that industry pressures are prompting them to adopt new business models, enter new global markets, and expand alliances and partnerships. As they execute on these initiatives, they simply must become more strategic in how they manage information across this extended network. Central to the drug lifecycle is content: from discovery and regulatory approval to commercial production, regulated content “follows” the drug. Therefore, one essential path to improving efficiency and productivity is by implementing life sciences– specific content management solutions that streamline and simplify processes and serve as a single authoritative source of truth. Question: What do you think has led to this market acceptance of our solutions? I’d say it’s the fact that companies can use our solutions out of the box, without customization. The solutions are completely integrated and configurable—encompassing compliant clinical trial documentation, research and development, storing and viewing of archived submissions, and control of quality and manufacturing documents. With a single source of truth, clinical, regulatory and quality stakeholders are able to link submissions and make sure content is accurate and up-to-date. With documentation in a single repository, it can be easily searched. This allows these organizations to make huge strides in reducing operational complexity. Our customers are also telling us that they truly appreciate the flexibility of being able to use our solutions in a private, public or hybrid cloud, or in a traditional on-premise deployment. With any of these choices, they can be confident in security, privacy and access control. Question: You mentioned pretty impressive growth for the solution suite over the past four years. What’s made the difference? First, the great majority of life sciences companies have used Documentum for years – the gold standard for compliant content management. So when we determined that life sciences companies had needs beyond that—as compliance became a given and efficiency emerged as a key driver—we made a big investment in this industry. That meant designing a very different solution suite with an information architecture based on industry reference models, and one that is flexible and configurable to meet the requirements of individual companies,their affiliates and partners. Usability is key here, too, because we learned that people at regional affiliates and infrequent users especially respond best to simple tools and a consumer-like experience. And since our life sciences solutions are built on Documentum, all these companies can protect their existing investment when they adopt our industry solutions. Question: Can you give us an example? Sure. Really exciting news is that PAREXEL, a leading contract research organization (CRO), offers an end-to-end RIM and regulatory content management solution. PAREXEL is combining its InSight RIM platform with our solution suite to give companies a complete solution for a product’s complete regulatory lifespan, from strategy and planning to authoring, publishing, submitting and archiving. Question: That’s fantastic news. What was PAREXEL’s reasoning? Well, PAREXEL’s customers are facing a real challenge in navigating a regulatory landscape, both globally and regionally, that seems to become more complex by the day. PAREXEL wants to help them do that with a single solution they can use for regulated content throughout the product lifecycle. It just makes sense to bring together the industry-leading solutions all hosted within PAREXEL’s Regulatory Cloud. Question: You use the term “industry-leading.” What do you mean by that? That’s actually PAREXEL’s term! But given that seven of the top ten largest biopharmaceutical companies (according to the ranking in Pharmaceutical Executive) use Documentum for Life Sciences solutions, I think that’s a fair description. Question: You noted that EMC made an investment in product development. But what else is responsible for this market acceptance? We also brought on people in product development, marketing and services who understand the industry. For example, we acquired Sitrof Technologies back in 2013 to increase our Life Sciences services expertise to meet growing demand and we’ve developed an experienced, industry-leading sales team. When I’m talking with our customers, I love that I can offer a team of qualified experts who understand the Life Sciences business, can help determine the best path forward and have experience with the validation component of the implementation. We also offer tools for migrating large volumes of data with minimal risk, which enables streamlined consolidation of multiple systems. That’s another important benefit.

Read More