The Life Sciences Environment Is Evolving. EMC Documentum for Life Sciences Has Changed Accordingly. Here’s How.

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences. Follow @Mcktweet

We’re pretty excited about what our customers have been saying about our solutions—how much they appreciate the improvements in usability, collaboration, and seamless linking and sharing of content, just as a few examples. In my last blog, we examined the pressures that are driving them to adopt our solutions, and looked at some of the numbers: 6X growth over the past 3 years. Wow. How did that happen?

The quick explanation is this: EMC Documentum for Life Sciences solutions have changed to meet the evolving needs of the industry—in a very big way.

For our customers, it’s a wish come true. Think about it: seven of the top ten largest biopharmaceutical companies use our solutions. If they can protect and leverage their existing investments in Documentum—the industry’s most proven, trusted, scalable platform—by adopting solutions from EMC that integrate with it seamlessly, that is very good news. It’s perfect: they can stay on Documentum and still get comprehensive next-generation solutions from a single, trusted partner.

So what exactly did EMC do to build these business-specific solutions for regulated content management? I talked with Jennifer Wemstrom, senior director of product management for Life Sciences at EMC’s Enterprise Content Division, for her perspective.

Question: Jennifer, let’s start with what’s going on in the industry. What do you see happening?

Well, as in every other field, Life Sciences organizations have had to adapt to digital transformation. That means meeting today’s user expectations for ease of use, mobile-friendly interfaces, cloud availability, simple collaboration and so on. Users today are sophisticated and tech-savvy, and they expect to work with applications seamlessly. And globalization has made a huge impact, both the move toward outsourcing to contract research organizations and the like, and as well as expanding markets to emerging economies. Our solutions have responded to that reality.

And we recognized that, because of the need to respond quickly to ever-changing business needs, customers must limit the time and money they spend on customization. They no longer want to go it alone; in fact, they would far prefer to take advantage of best practices, standardization and lessons learned by their industry peers.

In that same vein is the desire to limit user training. Given demands for efficiency and cost control, there is simply no time for a learning curve, whether for new users at headquarters or at a local affiliate in, say, Brazil or China. It turns out that a great many people use the solutions only occasionally, which means that the experience has to be simple and intuitive. Infrequent users must be able to get it right away with minimal instruction.

Finally, and perhaps most important, we learned the importance of designing the solutions to drive process efficiencies and provide visibility across the extended enterprise. Users must be able to collaborate seamlessly, and to link and share documentation, with intuitive search capabilities. For example, multiple users should be able to edit a document simultaneously, and have the system automatically merge all the changes. And the central office must have visibility into regulatory activities, especially regarding local affiliates’ submissions, to assure accuracy, compliance and product safety.

Question: EMC has made a major commitment and significant investment in supporting Life Sciences. How have our offerings evolved as a result?

Most important is the integration of the various solution components, which are completely configurable and require zero coding. Companies can choose individual solutions that address the full drug lifecycle: compliant clinical trial documentation, research and development, storing and viewing of archived submissions, and control of quality and manufacturing documents. These are turnkey solutions; once they’re implemented, nothing more has to be done but to put them to use.

Each of these solutions uses standards and preconfiguration in document inventories, terminology and vocabularies that are driven by years of lessons learned, industry standards, as well as the latest guidance provided by the DIA reference models. This approach really speeds up deployment time, promotes harmonization and goes a long way toward ease of use thanks to familiar, repeatable processes.

And we are committed for the long term, looking ahead as we make ongoing investments.

Question: It sounds as though EMC brings a great deal of industry expertise to the table. Do you agree?

Yes. When we speak of investment, we mean people: over the past few years, we’ve brought in experts in product development, marketing, sales and services. That’s key, of course. And EMC already had 25 years of experience in Life Sciences. But equally important is our experience in content management. We have built all those years’ worth of lessons learned and best practices into our solution suite. In fact, EMC Life Sciences experts have led the way by extending the DIA EDM Reference Model to the quality domain.

Question: You’ve mentioned the importance of the user experience. Can you go into a little more detail?

These days, no matter what industry or line of business or job type, people expect a consumer-like experience. User interfaces need to be simple and intuitive. Tools need to be mobile-friendly so people can work on the go.

Our solutions are designed with all that in mind. And—this is an essential point—they are role-based and easily personalized, tailored to the primary tasks of that role. For example, the interface for a user who only reads content is different from that of someone who authors content. And the solutions can be personalized to ensure that everything a user needs is readily accessible. That’s what we mean by efficiency!

Question: How about the element of collaboration and sharing of documentation?

Our solution suite comprises what we call a unified solution layer that is built on a common data model. In short, the common data model ensures that all solutions across all domains are standardized; no more silos that function independently. So instead of importing documents from one system to another, documents can be shared and content reused. For example, a manufacturing specification is required simplify, simplified businessfor the submission, but is also maintained in the quality management system. The unified solution layer links the current approved content directly from one to the other. It creates a single version of the truth with content always accurate and up-to-date, and since the documentation resides in a single repository, it can be easily searched.

I also mentioned the importance of visibility across the enterprise. It’s the same concept. The corporate office can distribute the current, approved version of the content to the regional affiliates, while enabling them to create local content based on regional requirements and then communicate it back to headquarters. This not only helps maintain compliance, but reduces the workload. And here again: processes are streamlined and efficiencies gained.

Question: How can our readers find out more?

So glad you asked! Our readers are invited to attend Momentum 2016 at EMC World in Las Vegas, May 2–5. Stop by the Enterprise Content Division booth and see our Life Sciences solutions in action.

And you can see demos right in your office, just by visiting our online showroom.

Would you like to share your thoughts or experiences? Please comment here.

EMC and PAREXEL: On the RIM of Innovation

Lena Shafir

Lena Shafir

Product Manager, Regulatory Solutions, Enterprise Content Division, EMC
Lena Shafir is the Product Manager, Regulatory Solutions, with over fifteen years of experience developing and implementing electronic content management systems for Life Sciences industry. In the last few years she has worked as a Subject Matter Expert for multiple global EDM projects, specializing in Regulatory and eCTD.

Last week, we announced an alliance with PAREXEL to deliver a cloud-based, end-to-end Regulatory Information Management (RIM) solution. I want to share this exiting news and provide my perspective on the importance and value-add of this endeavor.

Organizations with regulatory requirements, particularly those in Life Sciences, understand that RIM can be complex, and time- and money-consuming in its implementation. According to the 2015 Gens & Associates report, Next Generation Regulatory Information Management and Intelligence; Strategy, Investments and Status, over half of Life Sciences industry survey respondents had a cross-divisional RIM program in place, and this increased to 77% for the larger multi-national companies. Which means that if you do not have RIM strategy in place, you are already behind your competition.

Why is RIM so important?

Life sciences companies are under pressure to balance innovation with cost-cutting measures, across the enterprise. They need to reduce the costs of regulatory operations and speed up health agency approvals to accelerate time-to-market. Effective RIM strategy and solution implementation allow organizations to stay competitive, compliant and informed. While providing needed medicine to patients quickly is an honorable objective, delivering on it is easier said than done.

 

It’s complicated!

Despite a diverse range of tools in place to help analyze, interpret and share information, what is typically missing is a coordinated effort across the enterprise supported by integrated systems for regulatory operations. Yet, even after making significant strides in establishing cross-divisional RIM programs, many companies are still not meeting their efficiency goals. Processes span a myriad of disjointed systems, exacerbated by mergers and acquisitions and an extended enterprise encompassing global partners. In fact, the Gens report references 16 capabilities that are needed to support global regulatory activities and the list is still growing. You can imagine the challenge of taking multiple systems and determining if (and how) to integrate them to drive a seamless, efficient global regulatory process.

The Role of Content Management in RIM

Content management is a vital component of any RIM initiative. After all, content is associated with the drug starting at discovery and stays with it throughout its lifecycle. EMC offers a Life Sciences solution suite that facilitates and supports information access, sharing, visibility and communications across the extended enterprise—for both internal and external participants. However, the ability to provide extended integration capabilities is critical to ensuring a perfect fit in an enterprise-wide RIM strategy. Each company will likely have its own unique situation in terms of product types, markets engaged in, IT systems in place, and the overarching goals and objectives.

Document management is a vital component but it does not cover all RIM requirements in a silo. This is why the EMC and PAREXEL partnership is so exciting.

Two Industry Leaders Unite

Both EMC and PAREXEL are market leaders in the Life Sciences industry. EMC Documentum has been the leading content management platform for over 25 years. PAREXEL® LIQUENT InSight® Regulatory Information Management platform has been a leading industry solution for submission planning, registration tracking and publishing. By forming the alliance, we bring to our customers a fully developed, time-proven and tested, cohesive solution to cover end-to-end regulatory business processes. What is even more interesting, these capabilities are delivered with a cloud-based offering to greatly simplify systems maintenance and upgrades.

“This alliance is the combination of two life sciences powerhouses joining forces to provide further value to the industry,” said Steve Gens, managing partner of Gens & Associates when we spoke to him. “EMC and PAREXEL’s ability to provide a cloud-based Regulatory Information Management (RIM) ecosystem aligns well with most companies’ RIM strategies.”

Furthermore, this partnership will afford our teams to work closer together to extend integrations between our products to add efficiencies to the process and intelligence to systems communications.

If RIM initiatives and solutions are on your mind, come talk to us. We’ll be at the Informa RIM Conference in Madrid, Spain on April 26th – 28th. You can also leave us a comment here or visit our website at www.emc.com/documentumforlifesciences.

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

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences. Follow @Mcktweet

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 EMC 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 John Loucks, head of U.S. sales for Life Sciences industry solutions at EMC’s Enterprise Content Division, to get his perspective on what’s driving this growth.

Question: John, 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 Continue reading

Driving Transformation with Analytical Insights

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences. Follow @Mcktweet

The Life Sciences industry is in a state of flux. Against the backdrop of patent losses and pressure to accelerate time-to-market for new medicines, today’s business realities and governmental reform are driving new models of healthcare. The new models demand lower costs and prioritize positive, measurable outcomes and patient well-being.

Data analytics 99760451Life Sciences organizations are tasked with thinking outside the box to find 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. When it comes to digital transformation, big data analytics offers a way to accelerate the finding of key connections and insights while enabling faster, data-driven decision making.

The Role of Analytics in Digital Transformation Efforts

It goes without saying, the entire health sciences eco-system needs to shift and transform to realize the most important objective, to improve patient health. Digital transformation and analytics can plan a role here. For example, Continue reading

29 Days of Digital Maturity: February Highlights

Jill Orbell

Jill Orbell

Marketing Program Manager in the Enterprise Content Division at EMC. Twitter: @jillorbell

As we leap in to March, let’s take a look back at what bloggers shared during the month of February. Over the course of the month we focused on Digital Maturity and why it’s a crucial part of the future of any business.

Throughout the month we looked at the current state of transformation in the Life SciencesDigital Maturity industry and what that means for the future. outlined steps that can be taken to accurately and efficiently exchange eTMF content. She also sat down with EMC’s own Mary Gallagher to discuss her DIA presentation, “Managing Global Submissions – From Identifying Core Content to what is Actually Submitted.” Did you attend DIA? What Life Sciences industry trends did you find most notable?

We continued the month of blogs with John O’Melia discussing why customers are “enamored by Captiva.” He detailed the ways Captiva transforms business beyond just getting rid of paper. He also shared eight examples of how Captiva has positively impacted our customers’ businesses. Additionally, we continued the focus on Continue reading