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Life sciences set for the next stage of a technological revolution

Written by Sonja Vlašič in Life Sciences on 23/05/17


AMPLEXOR recently staged its 19TH annual life sciences conference, BE THE EXPERT 2017. Across three days of debate, discussion and presentations in Budapest, delegates learned more about some of the issues facing the life sciences industry in 2017 and also about some of the technological solutions that are available to address these issues. Elvis Paćelat, Vice President, Life Sciences, AMPLEXOR, gives an overview of what was discussed and where he feels the industry is heading.

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

Written by Steve Gens in Life Sciences 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

Written by Steve Gens in Life Sciences 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

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.

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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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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