xmLabeling: A Modern Prescription for Drug Labelling Headaches

Tom Broering

Tom Broering

Head of Americas Alliances and Channel Sales, Enterprise Content Division at EMC

How’s this for a medical nightmare? 50 different labels for the same drug. It can and does happen.

A major U.S. pharmaceutical company needed major help to gain control of its labeling system, which had become bloated, redundant, scattered, expensive and incredibly difficult to manage.

I caught up with Viren Gupta Vice President of Technology Solutions and Content Management at EMC partner Glemser Technologies, to see Dozens of Pill Bottleshow content pros were coping with the issues in this intensively-regulated and highly challenging environment. “At its best, drug labeling is a highly dynamic process,” began Gupta. “Everything keeps changing, and it’s not unusual to end up with multiple labels.”

Dynamic is an understatement. Monumentally complex is more appropriate. It’s challenging enough to satisfy the strict demands of the U.S. Food and Drug Administration: annual submissions, XML format, supplemental filings for any change in the drug’s strength and other factors, specific language and format for Package Inserts, Summaries of Product Characteristics, Core Data Sheets… the list goes on.

Now imagine the potential headaches when a drug is marketed globally by a company operating in 170 countries, with a workforce in the tens of thousands. How exactly do enterprises stay current and compliant when a U.S. label may not fly in Dubai, or a Continue reading

Faster Mean-Time-to-Summer with Life Sciences Content Management

Adam Kelch

Adam Kelch

EMC ECD Product Manager – Documentum for Life Sciences Clinical Solutions

In many professions, what stands between a working professional and a summer vacation is a task list that involves quite a bit of content. This might require tracking down correct document versions and gaining content approvals, before anyone on the work team can responsibly enjoy a vacation.What Motivates You

It’s in these pre-holiday moments that content management efficiencies earn their proper due, as professionals consider MTTS — “mean-time-to-summer.” How quickly and accurately can their hefty task list get executed in order to still go on vacation?

Just like technical support personnel measure “mean-time-to-resolution” (MTTR), counting how long it takes to close a help desk ticket, our EMC Life Sciences customers can measure MTTS thanks to our latest content management solutions. Using portals, intuitive file uploads and single sign-on, they can post record MTTS times, even amidst clinical trials.

The Trials of Clinical Trials

Our Life Sciences personnel frequently face significant paperwork hurdles amidst their tight regulatory environment. During clinical trials, clinicians and investigators especially need to manage many interactions with multiple pharmaceutical sponsors.file Stack For the startup phase alone, a single sponsor requires various signed documents from each site, and a site may be running multiple clinical trials simultaneously. It’s in these settings that automation and electronic collaboration can save time, while still ensuring accuracy.

Expediting Investigations

EMC’s Investigator Portal can help drive down MTTS by electronically distributing and collecting required documentation. The portal, part of the EMC Documentum Electronic Trial Master File solution (Documentum eTMF), centralizes where and how Life Sciences staff work on trial content. It keeps all documents visible and organized within a single repository.

Even for those organizations who have an existing Investigator portal, or those planning to use the future industry-developed Transcelerate portal, integration with EMC Documentum eTMF can expedite paperwork and processes.

MTTS for our EMC Investigator Portal customers? Low!

Leveraging EMC expertise in content management and the Life Sciences sector, Documentum eTMF and its Investigator Portal eliminates hours of tedious document management with a user friendly experience. Imagine MTTS for Investigators if they could:
• Select and upload trial documents quickly and easily, in one centralized location
• e-Sign required documentation with 21 CFR Part 11 compliant electronic signatures
• Find all essential documents, information and communications in your portal, 24/7

Digital Acknowledgements & Real-Time Notifications

As responsible stewards for patient safety, both sponsors and Investigators can leverage real time notifications, access and digital acknowledgements. This includes Continue reading

Objects are Closer than they Appear – New Content Management Cloud Data

JD de Haseth

JD de Haseth

Director, Marketing — Cloud Services in the Enterprise Content Division (ECD) at EMC Corporation
Director, Marketing -- WW Cloud Services @ EMC Enterprise Content Division

The time has finally arrived. After many years of planning and customer outreach, we can actually compare how our ideas around cloud delivery platforms have truly played out pragmatically for content management customers. We have new customer survey data, which I’ll share momentarily.

1024px-Car-SideMirrorOne of my main takeaways, having worked on EMC Enterprise Content Division teams to define and build cloud solutions, reminds me of car side view mirrors in the 1990s: “objects are closer than they appear”. Looking back on what’s different now when it comes to leveraging cloud as we manage and host customer environments in our data centers, most prominent is how customer question sets have changed.

In the early days, a mere 3-5 years ago for example, content management cloud prospects were plagued with fears. Customers were, at best, described as trepidatious. The cloud was perceived as a dark and stormy, shady object. Fears around cloud appeared larger than they really were.

Security has been, and always will be, a priority on the EMC side. Yet less and less are customers today allowing fears to hold them back from the many benefits gained by EMC cloud solutions and applications. Security features and functionality are addressed and inherent in the offerings, and the focus quickly moves onto realizing the ease of quickly delivering and rolling out content management solutions to users and, of course, Continue reading

Big Pharma Ideas From Little Pharma Labels

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

My goal is to do everything possible to speed the spread of worthwhile drugs around the world. Every dollar a life sciences company saves through data efficiency is another dollar they can potentially spend developing a drug that may save someone’s life.” ~Ray Glemser

I figure that every day, big pharma organizations face two big challenges. Number one is certainly saving lives. But number two has to be controlling data. Consider the massive challenge of tracking clinical trials, drug interactions, and side effects—along with the regulatory information for every country in which a drug is made available. Imagine making sure all data submitted to health authorities around the world  is completely current, consistent — and in multiple languages.

One immediate hurdle is the start of Europe’s Identification of Medicinal Products (IDMP) protocol, said to be the biggest change for big pharma since the U.S. Food and Drug Administration went to its XML-based reporting system a decade ago. The European protocols require some 350 discrete points of information on each drug. Think about it.EMA logo

“It’s like the old system on steroids,” said Ray Glemser when I caught up with him the other day.  Ray is the CEO of the company also named Glemser—an EMC Content Division partner that builds a solution called xmLabeling. “It’s also the kind of complexity that drives our business, bringing us new customers who realize they have to step up their game.”

I was surprised to learn that xmLabeling does a lot more than make pharma labels. It creates a central repository that efficiently handles every label change and revision—along with lots of other data points. All related data is available in Continue reading

Five Goals to Strive For to Improve the Technical Transfer Process in Life Sciences

Jessica Kelley

Jessica Kelley

Quality Product Manager, Documentum for Life Sciences in the EMC Enterprise Content Division

In the drug development process, time to market, billions in IP investments, and most importantly, human lives are at stake. One of the greatest challenges of the process is ensuring that documentation is complete, accurate and carefully controlled in accordance with each phase of the drug’s lifecycle.

In my previous blog, I discussed the challenges of the technical transfer process. The technical transfer process is a systematic procedure that is followed to pass the knowledge and experience gained during development to the parties who will assume responsibility for commercial production of the product.

I described this process as often not discernible to virtual and geographically dispersed teams but a critical juncture in bringing safe, effective drugs to market. Because smaller quantities of drugs are manufactured to support the clinical trial process, organizations must ensure that the manufacturing process consistently adheres to defined specifications and acceptance criteria as scale up production occurs and the competency of the manufacturing site is evaluated.

Documentation is not only germane to this process, but once the documentation is transferred from R&D to manufacturing; new Good Manufacturing Practices Regulations (GMP) go into effect. This documentation continues to be revised and updated throughout the drug lifecycle and is intrinsically linked with R&D because when changes are proposed, they may require a re-submission to regulatory authorities.

So what can organizations do to streamline and automate this process to ensure an expeditious transition? Is there a way to facilitate better communication between R&D and quality and manufacturing as the documentation is updated and revised over time?

Five Goals to Strive For to Improve the Technical Transfer Process

1)  A Single Source of Regulated Content: The transfer of technology is accomplished primarily through written protocols and reports that can leave room for misinterpretation. This misinterpretation can be due to an inconsistent use of vocabulary across groups or disconnected sets of information that reside in system silos but which need to be shared holistically as part of the technical transfer process.

Continue reading