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.

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One Decision to Make Today

Adam Kelch

Adam Kelch

EMC ECD Product Manager – Documentum for Life Sciences Clinical Solutions

Managing a pharmaceutical business involves great complexity, yet there is a simple decision you can make today – adapt your information flows to your drug development lifecycle, not to your org chart. This one decision will impact both your daily operations and your strategic advantage.

Day-to-Day Impact:

Status quo among many Life Sciences firms involves exporting digital document sets from one domain (e.g. Clinical), just to share them and re-import to the next organization (e.g. Regulatory). Yet based on the DIA TMF and EDM reference Connectivitymodels, at least 20 documents initiated in one part of your organization will need to “cross-over” for reuse and trust in other parts of your organization.

These documents must belong in your eTMF for compliance purposes, and only the “latest and greatest” need to be ready for submission to the regulatory authorities. They’re the same documents, living in different part of your organization!

The result?

No single source of information truth as you move through clinical trials toward commercialization. Worse, the inability to find the most recent copy of these documents to fully comply with regulations. Worse still, insidious inefficiencies that chip away at your competitive advantage as these documents individually traverse your organization through email or who-knows-what medium.

By letting go of sharing documents “the old way” and adapting to one shared repository for both eTMF and regulatory documents, you can improve productivity, time-to-market, and even morale (who in Regulatory likes finding out about a protocol amendment during the conduct of a trial after they just spent months completing a submission?).

The new way to handle documents is by leveraging the tried and true – still using Documentum, but choosing Documentum eTMF and R&D solutions to solve both Continue reading

What Happens in Vegas, Stays in Vegas… or Does It?

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

A visit to Sin City as a content management aficionado makes it impossible to keep what happens in Vegas a secret. I returned from Momentum and EMC World 2015 eager to share with customers all the ways they can leverage the cloud as an underlying foundation for their enterprise content management strategies.

In terms that any Las Vegas visitor might appreciate, here are my top four EMC World 2015 insights to share. I hope these ideas and case studies inspire you to forge ahead and become the Digital Enterprise of tomorrow.

1 – Headaches arise from complicated IT application rolls-outs, not just from hangovers.

An estimated 80% of large enterprises will have deployed cloud environments by 2017, according to a 2014 Gartner Survey. As organizations transform into the digital enterprise, a razor-sharp focus on technology — and specifically, cloud deployments — will be the enabler to realize the next phase of growth. CIO’s and IT Director roles all rated “cloud is a modern approach,” “innovation” and “operational agility” as prime reasons on why making the journey to the cloud is a necessity today.

As EMC’s Enterprise Content Division showcased in the exhibit halls across EMC World, EMC enterprise content rationale to move to cloudmanagement solutions and products are available in a number of cloud deployment options. Deploying EMC Documentum in a public, private, or hybrid cloud helps alleviate installation and configuration challenges by leaving the complicated work to EMC technical experts. Depending on your needs, you may find that either a public or a private cloud model is a best fit. In some cases, it may be a combination of the two options – a hybrid cloud model. Bottom-line: it’s comforting to know that with EMC Documentum, you have choices! Talking with EMC experts, you can determine which cloud deployment model is right for Continue reading

The Best of the Best of the Best

Jason Capitel

Jason Capitel

Chief Revenue Officer, EMC Enterprise Content Division

The Best of the Best of the BestYou may not remember it, but there’s a line in the movie Men in Black where a character opposite of Will Smith says, “We’re here because you’re looking for the best of the best of the best, sir!”

This line came to mind as we were preparing for the EMC Enterprise Content Division (ECD) Partner Awards Dinner this week at Momentum at EMC World.

It’s no secret that our partner ecosystem is the best in the content management industry. Many of the solutions that they’ve built on our products have transformed the way that organizations – ones that you know or even work for – do business. They’ve helped these organizations thrive, and ultimately do amazing things like save lives and preserve historic documents. And they’ve helped EMC ECD be named a “Visionary” in the Gartner Magic Quadrant for BPM-Platform-Based Case Management Frameworks.

These partners, and those that resell and implement our solutions, are an extension of our EMC family. Many of them have been with us a good portion of our 25 years and are dedicated to seeing that our mutual customers are successful (by the way, you can help us celebrate our 25th Silver Anniversary by supporting charity: water).

In particular, I’d like to highlight International Turnkey Systems (ITS), the winner of our President’s Award for Customer Satisfaction. Both Rohit and I were impressed by ITS and their many stellar references. Consistent throughout was the emphasis on clear, dependable communications and thorough expectation setting. It was apparent that this partner is as passionate about having truly delighted customers as EMC is.

Although it was difficult to acknowledge just a few out of this fantastic ecosystem, I’m proud to announce the “best of the best of the best” and share my sincerest appreciation for all that they do.

Please join me in congratulating these partners on their tremendous effort and successes!

PHOTO FROM AWARD DINNER AWARD WINNING  ORGANIZATION AWARD DESCRIPTION/ SOLUTION NAME

Nasr Albikawi and Remy Foudapres award winner ITS

President’s Award for Customer Satisfaction International Turnkey Systems (ITS) Strategic focus on customer service; Exceeds customer expectations with the highest levels of satisfaction in services and solutions.

Bhavani Balasubramaniam and Suresh Ramachandrancosi

Innovation Award: Best Value Office Solution Cosi Consulting Insight

Gary Hodkinsoninoovo

Innovation Award: Best Capture Solution inovoo NOVO Mobile

Tim Nelms and Ernie Crawfordcrawford

Innovation Award: Best InfoArchive Solution Crawford Technologies PRO Archiver for InfoArchive

Bruce BoltonPortford

Innovation Award: Best ApplicationXtender Platform Portford Solutions DocuNECT Lifecycle Platform

Mario Duckettmario metasource

Innovation Award: Best ApplicationXtender Solution MetaSource MetaStor – ApplicationXtender for the Cloud

Ed Stevens

Innovation Award: Best Design Integration Award (OEM) Cerner Content 360

KEvin tompsettwindward mktg

Marketing Excellence Award The Windward Group Embracing EMC digital marketing tools and content, and going above and beyond with digital marketing efforts

Joe Mihalikflatiorns2

Partner of the Year – Overall Flatirons Solutions Revenue contribution and focus on building solutions that support ECD’s revenue priorities in 2014

James Robinson and Nikki Hansellpaperfree

Partner of the Year – AMER PaperFree (same as above)

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Partner of the Year – APJ Impact Systems (same as above)

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Partner of the Year – EMEA Deloitte (same as above)