Views and news


Pursuing World Class RIM Part 4: Authoritative Source and Data Standards Update

Posted by Steve Gens on 03/01/17

Designation of specific RIM systems and repositories as the authoritative source for regulatory information has been the standard for many years as evidenced by our previous RIM research. In 2016 we took the next step towards understanding regulatory information authoritative sources by asking each company to assess their confidence in the data within the authoritative source for 10 essential capabilities.

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Pursuing World Class RIM Part 3: Applying Emerging Technologies in the RIM Space

Posted by Steve Gens on 23/11/16

We have been discussing and anticipating the promise of emerging technology to significantly improve Regulatory Information Management (RIM) systems for the last few years. Historically traditional methods, such as more powerful servers and faster internal networks, shared workspaces and incremental software upgrades have provided relatively little business improvement.

With the advent of significant new regulatory requirements, such as IDMP, and the continuing recognition that regulatory information is a largely underutilized corporate asset, we see four promising emerging technology areas as relevant to world class management of regulatory information.

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Pursuing World Class RIM Part 2: Comparing RIM Operating Models

Posted by Steve Gens 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?

Posted by Steve Gens 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.

This world class journey started in 2014 where a top rated company from our 2014 RIM survey was disappointed in their peer ranking as they rightfully believed there was a tremendous amount of work to be completed and value to be realized. We reflected on this and quickly determined that having just a peer ranking without a target or “gold standard” to achieve would never give a true industry status. We went to work with the help of 18 companies in four design sessions in the fall of 2015 to define the first world class RIM baseline. This entailed detailed discussions and debate of “what is world class RIM?” and more importantly “how do you measure it?”.

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AMPLEXOR´s Digital & Regulatory Transformation @ Momentum Barcelona

Posted by Joana Vilhena 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.

For the last 20 years AMPLEXOR Life Sciences has been helping life sciences organizations accelerate their speed to market and enter new countries quickly. With our solutions and services, we expedite the creation and delivery of consistent, compliant and high-quality global content across all of a company’s target markets.

In this sense, Momentum Summit will be a great chance for us to tell our story, share our experiences and present our vision of the future, with special focus on digital transformation.

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Regulatory transformation: cloud reality check

Posted by Siniša Belina 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

Posted by Chris McLaughlin 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

Posted by Steve Scribner 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

Posted by Steve Scribner 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

Posted by Siniša Belina 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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