The Regulatory Radar in Life Sciences: Reference Models in Motion

Steve Scribner

Steve Scribner

More than 20 years experience in business strategy and implementation of Content Management in Life Sciences at EMC

There has been a common cry for consistency and harmonization in Life Sciences around managing the Intellectual Capital of the business. Efforts started over 6 years ago to develop flexible, open, free and sustainable reference models by the industry, for the best practicebenefit of the industry with ownership held by the industry. These have become known as the DIA (Drug Information Association) Reference Models.

While quite a few of you are familiar with the EDM (Electronic Document Management) and TMF (Trial Master File) models, several new ones are also in current development.

  • Labeling – a draft is currently published in the EDM model, version 1.3. An update is coming. This update will include refinements based on implementation experience. It will also introduce a new visualization tool that will help users to better comprehend and use the model. This method of graphical representation will be extended to the existing EDM and TMF models as well as all new models. The plan is to release it for public comment, most likely in the second quarter of 2015.
  • Quality & Manufacturing – A new model is being built. Previously, coverage in the models for Q&M has been limited to documents in the submission process (within Development). These documents are currently defined in the EDM model (Module 3 of the eCTD, Electronic Common Technical Document.) This new Q&M model will add Manufacturing and Quality documents from the commercial processes that follow marketing authorization. Policies and Procedures will also be included. This new model is a considerable extension that expands the scope of the models to cover more of the Life Sciences business. The current plans are to release this model for public comment late Q1, 2015.
  • Medical Devices – Development of a reference model has begun. The pending Regulated Product Submission (RPS) standard, authored by Health Level 7 (HL7), specifies that all regulated products will be covered. To meet that standard, a new Reference Model for Medical Devices is required. A committee has been formed and will work towards a public review sometime, probably late, in 2015.

Even the existing models need maintenance and periodic updates to reflect our Continue reading

The Regulatory Radar in Life Sciences: 2015 Considerations

Steve Scribner

Steve Scribner

More than 20 years experience in business strategy and implementation of Content Management in Life Sciences at EMC

In life sciences, our future is heavily governed by the actions of the major regulatory agencies in the world. To get a better view into the future of 2015, we carefully listened to the information heard at conferences, published in official channels on the web and gleaned from our colleagues within the life sciences community. I’d like to share with you the important topics that may have a critical impact on your business. These topics should be on your radar for 2015.

Let’s start with what I mean by “radar.” Radar was a term that was invented in the beginning of World War II (1940) by the US Navy and it stands for the detection of objects Globe+Radarusing radio waves.  Early on, the military was interested in ships and planes. More so, they were interested in whose ships and planes were in motion and where are they going. They wanted to know if these objects were a threat.

A more current use of the metaphor can be found in the tremendous complexity of airport traffic control and the vast number of objects in motion. In Life Sciences, we not only need to listen to government agencies and standards organizations that govern this regulated business but we also pay attention to what experiences sponsors are having and what the vendors are seeing as well. Timelines for implementation are considered for priority. Conditions of non-compliance are the threat. As in times of war, not all threats can be considered equal.

One of the regulatory initiatives that has emerged from Europe over the past several years is IDMP, and its predecessor XEVMPD. IDMP stands for Identification of Medicinal Products, and is a set of standards whereby safety events can be consistently linked to a particular product anywhere in the world. On the surface, the association of an Adverse Event to a product is elementary. But it’s not so simple. The company identifies its products differently in different markets of the world. Implied within these standards is a requirement to correlate all Continue reading

A Flexible, Single Throat to Choke

Dave Hsu

Dave Hsu

Marketing Manager for EMC’s Life Sciences Content Solutions with responsibility for building awareness, advocacy and adoption of EMC’s market leading clinical and quality offerings.

Last month I blogged about finding your Journey to the Cloud showcasing man covered in sticky notes FAN1005910
ORC International’s Part 1 report about what’s driving public Cloud in Life Sciences content management. This month, I had a Q&A session with Kenny Blumenfeld, Research Director at ORC, to give us some insights on Part 2 of this report:

Dave: Part 1 of your analysis showcased the industry forces driving Cloud adoption, what does Part 2 delve into?

Kenny: This report dives a level deeper into the business needs of both large and mid-size life sciences companies for regulated content management. From there we analyzed the landscape of current day solution options.

Dave: What did you uncover in terms of needs?

Kenny: We found a couple of themes: First, whether you’re a big or small organization, compliance is king for content management. Secondly, smaller organizations typically have fewer IT resources, they require more flexibility in Cloud deployment options, and are more likely to utilize outsourced IT alternatives to lower their overall costs.  

Dave: What solution options do organizations have?

Kenny: We analyzed two categories of content management solutions: multi-vendor and single vendor. Multi-vendor options are applications built on top of enterprise content platforms by third parties.  These are solutions such as CSC FirstDoc, built on top of EMC Documentum, or NextDocs on Microsoft Sharepoint. Single vendor options combine the content management platform with life sciences process expertise, so in essence the content engine together with the application from one vendor. Examples of these would be EMC Documentum for Life Sciences Solution Suite or Veeva Vault.

Dave: Are there advantages of one option versus another?

Kenny: Of course, it always comes down to business needs, and how well a given solution meets those needs. Our research indicated that the multi-vendor approach sometimes creates additional complexity in implementation and support, and this tends to be especially acute when problems arise and it is unclear where fault lies in the overall system. The “hot potato” effect is probably all too familiar to a lot of your readers. It is not a new issue, and it certainly is not unique to content management in the life sciences.

In this research, the single-vendor solutions mitigated that issue, while also offering the benefits of being tightly integrated with the underlying platform. Companies we talked to said there was significant value in having a ‘single throat to choke’.

Dave: Ouch…sounds painful! So what are the key takeaways from your analysis, and how can folks get a copy of the reports?

Kenny: Between the two-part analyses I would summarize with three key points:

  1. Life sciences organizations are slower to adopt cloud, especially when it comes to regulated content in the public cloud.
  2. Compliance and security is king, but the mid-market has a greater need for deployment flexibility, more IT outsourcing and lower cost
  3. A single vendor approach delivers a clear owner for support, as well as timely updates in coordination with platform enhancements.

You can read the details from both reports from our website:

So there you have it – flexibility in Cloud, lower costs and single vendor solutions are strong characteristics of content management solutions in Life Sciences. What are your thoughts on ORC’s research? Does your organization view Cloud similarly?

When You’re Finished Changing You’re Finished!

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

Benjamin Franklin seems like a man wise before his time or maybe it’s true that the more things change; there are some truths that will never change. Regardless, Ben Franklin’s quote succinctly describes the change that the life sciences industry is experiencing.

Life Sciences organizations are grappling with increasingly stringent regulatory requirements, pricing pressures and skyrocketing costs. To drive revenue, organizations are exploring ways to identify new indications for existing drugs while continuing to expand into emerging markets. Business models also continue to change with business processes now taking place in collaboration with multiple external partners from academic research institutions to clinical research organizations to contract manufacturers and beyond.

As industry pressures and business models change, so must the technology that supports the business. Organizations of all sizes aim to streamline how information is shared both internally and externally and both colleagues and partners need a simple and easy way to access information both in the office and on the go. IT leaders must respond to these demands while trying to consolidate systems, determine when to use third party hosted applications (or even outsource altogether) and while trying to divert budgets away from maintenance to investments in technology innovations that will better support business needs. And of course, all of this happens in a highly competitive and regulated environment where securing and preserving intellectual property and being in compliance is paramount.

So where does that leave you? Perhaps feeling like you need a reminder of how to constantly anticipate, monitor, respond and adapt to change and some ideas that might provide guidance? If so, we can help.

On December 4th, we’ll be hosting a webcast where you can gain an understanding of the three pillars of the EMC Documentum for Life Sciences solution suite strategy. Our goal is to share with you our thoughts on how to unify content-centric business processes, derive greater value from some of the investments you may have already made, and provide you with ideas on how to free up maintenance dollars by consolidating systems and employing cloud solutions in a flexible and secure way.

Attend this webcast and hear Jennifer Wemstrom, EMC’s Senior Director of Life Sciences Product Management, share her thoughts on how we can redefine life sciences together!

We will be holding this event at two different times to accommodate multiple time zones. Register here if you prefer the 10:00 am EST event. Register here if you prefer the 12:00 pm EST event.

What are the changes you’re grappling with?

Betcha Didn’t Know We (At EMC Documentum) Did That!

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

We’ve all experienced it. You’ve done your preliminary research for a vacation, car or other consumer good. After reviewing the websites of the top brands, checking out available ratings and reviews, and checking in with friends and family who may have made a recent similar purchase, you’ve gained some clarity but you are still confused. On the surface, all the options sound pretty similar. This familiar consumer experience also holds true when searching for solutions in life sciences.

If you look at the competitive landscape for life sciences solutions, you see multiple, viable vendors. Yet, if you peruse their websites, you’ll see a pattern of familiar and similar messages focused on performance, scalability, access, ease-of-use, efficiency, configurability, compliance, control, collaboration and cloud. With so many vendors extolling similar benefits to customers, how do you ask the right questions and make the right decision?

With so many vendors extolling similar benefits to customers, how do you ask the right questions and make the right decision?

It’s never easy. Buying cycles for significant, mission critical applications can be a complex process. The key is to cut through the clutter. To make a good decision, you need to search deeper and increase your knowledge and understanding. In our recent Life Sciences Customer Advisory Board meeting, our conversations not only focused on the “what” but more importantly, on the “how.” Understanding “how” vendors are delivering their stated value is key to simplifying decision-making.

Here are some examples of the “how” approach to get you thinking. Instead of taking the claim of global scale and performance for granted, ask how. Instead of focusing on a single business process, look beyond it to determine how critical information flows in and out of that process….is there an opportunity to share or link content instead of having to import and export the same information across systems? If cloud is important to you, understand how you would deploy it. What type of cloud solution do you need – private, hybrid, or multi-tenant― or maybe some combination of all three? And, it would probably be good to know how the vendor will get you from your current solution to the new solution and how to address all the (soon to be legacy) data that needs to be retained and accessible.

At EMC, we want to answer your “how” questions. And, we suspect that there’s a lot we’ve been up to lately that you may not be aware of. Therefore, we are launching a video series called, “Betcha Didn’t Know We Did That.” These are short, snappy and fun video snippets that highlight some of the ways we’re redefining life sciences with the EMC Documentum for Life Sciences solution suite.

We hope these videos will catch your attention, make you smile but more importantly, highlight challenges that we’ve all grappled with. We hope these videos entice you to ask us questions, have deeper conversations with us and understand the how. Our first video is focused on the regulatory submission process. If you’re looking to bring control to this mission-critical process, take a peek below. Keep checking back for new videos and the start of new conversations.Together, we can redefine life sciences!

What would you like to redefine? Share your comments below.