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So far Gens Associates has created 84 blog entries.

The Promise of Enterprise RIM – What’s Slowing the Innovation Potential?

Regulatory Information Management (RIM) is one of the highest priority investment areas in Life Sciences R&D today, driven by the need to greatly improve the efficiency of regulatory globally, currently averaging 43% across 18 RIM capabilities[1], and manage regulatory information as a true enterprise asset. In this paper, we will examine why – even now [...]

By |2020-06-15T17:30:02+00:00October 9th, 2019|Whitepapers & Market Reports|

Gens & Associates Announce Premier Benchmark Membership Program

Gens & Associates today announced the launch of their Benchmark Premier Membership. The program gives members access to the latest and most respected Regulatory Information Management (RIM) benchmarking data and access to global expertise.

By |2022-03-15T14:48:03+00:00October 3rd, 2019|Press Releases|

The Promise of Enterprise RIM – What’s Slowing the Innovation Potential?

Regulatory Information Management (RIM) is one of the highest priority investment areas in Life Sciences R&D today, driven by the need to greatly improve the efficiency of regulatory globally, currently averaging 43% across 18 RIM capabilities[1], and manage regulatory information as a true enterprise asset. In this paper, we will examine why – even now [...]

By |2019-06-11T16:17:33+00:00June 10th, 2019|Whitepaper|

Terminology Consistency is the Key

There are growing efforts to improve the connection between regulatory information management (RIM) systems and enterprise resource management (ERP) solutions used for product change control and supply release. We know that improving data management and connections to other functional areas (clinical, safety/PV etc.) is a priority for companies.

By |2019-03-09T18:35:18+00:00March 9th, 2019|Blog|

Three Ways to Enhance Your RIM Program and Drive Productivity

Over the years in developing the Gens and Associates surveys we’ve learned a great deal about developments in regulatory information management (RIM), including what companies are doing and thinking, what they’re concerned about, what they’re planning, and the effectiveness and efficiencies gained from RIM.

By |2019-03-09T18:36:19+00:00February 25th, 2019|Blog|

World Class RIM – Whitepaper; Connections to Supply Release, Product Change and QMS

Regulatory Information Management (RIM) is clearly transitioning to an enterprise capability with growing connections to other critical functional areas while some potential “game changing” technologies emerge. Our 2016 World Class RIM baseline has now moved to an industry standard based on our 2018 research results and input from 31 contributing companies in our design [...]

By |2020-05-29T19:14:13+00:00October 10th, 2018|Whitepaper|

RIM Across the Enterprise: The Importance of Connecting with other Functions

In my last blog, I shared with you some of the findings from our recently completed 2018 World Class Regulatory Information Management; Connections to QMS, Supply Release, and Product Change Survey. In particular, I spoke about the progress made with RIM investments and how these are – or aren’t – impacting efficiency and data quality.

By |2018-09-14T16:28:35+00:00September 14th, 2018|Blog|

Are RIM Investments making a Difference? Understanding 2018 Survey Findings

We recently completed our 2018 World Class Regulatory Information Management; Connections to QMS, Supply Release, and Product Change Survey in April of this year. This was our 33rd benchmark and fourth focus on Regulatory Information Management (RIM). There were many significant findings, but I will focus on just a couple in this blog.

By |2018-09-14T16:10:45+00:00August 14th, 2018|Blog|

Regulatory Outsourcing Drivers Shift to Efficiency, Cost Control, and Talent Supply: Gens Survey

Over the past decade, outsourcing has become an intrinsic part of how life sciences companies operate. Since we began tracking outsourcing in 2007, we’ve seen constant growth to the point that in our 2014 survey analyses we declared that outsourcing is no longer a growing trend, but in fact common practice.

By |2017-05-19T01:28:00+00:00October 27th, 2016|Blog|
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