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Pursuing World Class RIM Part 2: Comparing RIM Operating Models

Written by Steve Gens in Life Sciences on 17/11/16


For years, RIM software vendors have talked about the importance of having a common platform or suite of products for successful management of regulatory information. For industry, a “common” capability requires much more than a set of tools. It requires common processes across sites and geographies, standardized data definitions and entry criteria for the information captured within the RIM systems, as well as enforcement of those standards.

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Pursuing World Class RIM Part 1: What is World Class RIM?

Written by Steve Gens in Life Sciences on 08/11/16


Me and my colleagues (Greg Brolund from Chicopee Falls Consulting and Sarah Powell from Powell Regulatory Services) write an annual white paper to provide a clear industry status of Regulatory Information Management (RIM) highlighting the current state, key trends and priorities, investment focus, projected capability and organization change, and a comprehensive update on the provider landscape. This year we have an exciting addition that focuses on defining and measuring World Class RIM.

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AMPLEXOR´s Digital & Regulatory Transformation @ Momentum Barcelona

Written by Joana Vilhena in Life Sciences on 31/10/16


We’re ready to kick off EMC Momentum in Barcelona Momentum in Barcelona today. AMPLEXOR´s team is excited to meet and spend time with customers, partners and simply curious people, discussing the currently status of the market and the opportunities ahead.

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Regulatory transformation: cloud reality check

Written by Siniša Belina in Life Sciences on 19/10/16


An industry debate at AMPLEXOR’s annual user conference in June examined the role of cloud services in driving the next generation of regulatory information management in life sciences, and I want to share with you the main points of the discussion.

The need for regulatory information management (RIM) transformation is driving new interest in cloud services, particularly access to the latest applications via Software as a Service (SaaS) delivery models. But there are different approaches to the cloud, and data sensitivities to consider, so it is rarely a straightforward decision.

It was in this context that AMPLEXOR recently hosted a major industry panel debate, keen to sort the fact from the fiction and establish some best-practice approaches to cloud-based service use in life sciences. The discussion, chaired by Steve Scribner of consultancy The Scribner Group, brought together heavyweight regulatory experts and consultants from across the sector: Romuald Braun of uanotau; Peter Brandstetter of IBM’s GBS Life Sciences team; Torben Thorhauge of NNIT; and Steve Gens of Gens Associates. The audience, made up of AMPLEXOR customers, also participated in the debate.

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3 Reasons You Can’t Miss This Year’s Momentum Europe

Written by Chris McLaughlin in Life Sciences on 06/10/16


It seems hard to believe, but October 31 is just a little more than a month away. Our team is busy putting the finishing touches on Momentum Europe and we are preparing to welcome both business and IT decision-makers from across a number of different industries and from around the globe, including Europe, the Middle East, Africa, Asia and beyond.

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IDMP and the Requirement for Substance Information

Written by Steve Scribner in Life Sciences on 03/10/16


IDMP is an important concept and pending requirement for all Pharma. There have been many white papers, webinars and conference talks addressing it. It will surely require a responsive and collaborative organization to discover and collect the required information that will be demanded, even for Iteration 1. I hope that most of you have been busy analyzing the gap between your current capabilities and the future specifications.

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Update to IDMP Iteration 1

Written by Steve Scribner in Life Sciences on 23/06/16


The ISO IDMP Task Force met in April to compile recommended changes to the content of the information model. A revised draft version was scheduled for vote in the meeting on May 12. A revised timeline was also on schedule to be discussed. We will publish an update in the next blog.

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Regulatory transformation: the time is now

Written by Siniša Belina in Life Sciences on 21/06/16


Regulatory compliance has always been a double-edged sword for life sciences. It is an essential and central focus for investment because public safety, consumer confidence and sales depend on it. Yet this preoccupation with rules and risk can also be a barrier to innovation, because any deviation from the status quo increases the chance of non-compliance.

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Reinventing data management, with R&D at the centre

Written by Steve Scribner in Life Sciences on 30/03/16


Every business, and often every department, has its own way of doing things. In the life sciences industry this is true of the way companies and individual business functions record and manage information about drugs, making it difficult to gain a clear line of sight across a product’s lifecycle and its performance in the market. This has implications for the business as well as public safety.

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Agility

Written by Steve Scribner in Life Sciences on 25/01/16


Agility has become the magic word symbolizing Nirvana. To be ‘agile’ is a capability or state that everyone in business wants to achieve. Companies struggle to get their minds and their hands around it. They feel that if they cannot achieve ‘agility’, then they cannot successfully compete in our fast-moving market.

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