Gens Associates

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So far Gens Associates has created 81 blog entries.

Regulatory Organizations in a Pandemic World

The COVID-19 Pandemic continues to make its global impact on Regulatory organizations. Since March 2020, the entire life sciences industry transformed in many ways to develop, produce, and deploy innovative treatments for this disease that has caused so much global destruction.

By |2021-01-29T21:40:02+00:00January 29th, 2021|Blog|

2020 World Class Regulatory Information Management (RIM) Whitepaper

2020 World Class Regulatory Information Management (RIM) Whitepaper Fall Edition – Based on our 2020 World Class RIM: Is Industry at a Performance Tipping Point? Study This paper provides insights from our 2020 study, explores pathways to achieving a high performing RIM program, and highlights learnings from the study top performers. We review [...]

By |2021-04-20T17:50:14+00:00November 23rd, 2020|Whitepaper|

The Evolving Role of the Regulatory Affairs Professional – By Preeya Beczek

The Evolving Role of the Regulatory Affairs Professional By Preeya Beczek - Independent Regulatory Affairs Expert Typical Eras and Environments for the RA Professional Key skills and qualities of a RA professional Key RA skills as an Operational Resource Key RA skills as a Business Leader Key RA skills [...]

By |2020-12-07T02:40:28+00:00November 17th, 2020|Whitepaper|

RIM Software and Technology Landscape Market Report (Fall 2020)

RIM Software and Technology Landscape Market Report (Fall 2020) This regulatory software market report provides an independent 3rd party analysis of the regulatory software provider landscape status, key trends and total addressable market (TAM). It includes: Key Regulatory and Technology Trends Software Provider Market Share, Customer Satisfaction, and Innovation Index Implementation Partner [...]

By |2020-11-16T16:34:55+00:00September 25th, 2020|Whitepapers & Market Reports|

Strong Organizational Elements Lead to Strong RIM Performance

Our benchmark data doesn’t just measure current industry experience and trends, we also strive to understand the cultural indicators and motivations of organizations, what we are calling the “secret sauce”, that creates the optimal environment needed to support performance improvement for Global RIM programs.

By |2020-08-07T18:40:01+00:00August 7th, 2020|Blog|

Why Amazon Thinking Might be the Shot in the Arm Regulatory Needs to Transform

When John Cogan and I connected at the February DIA show in Washington DC this year, we began chatting about “what’s holding regulatory back”? Life sciences companies began increasing their investments in regulatory information management (RIM) capabilities between 2014 and 2016 and many are still not seeing measurable improvements.

By |2019-10-22T01:18:42+00:00October 22nd, 2019|Blog|

Regulatory Operations Service Provider Market Report (Summer 2019)

Regulatory Operations Service Provider Market Report (Summer 2019) Study Overview for Premier Members This market report provides an independent 3rd party analysis to the regulatory service provider landscape status, key trends and total addressable market (TAM) Regulatory Services Trends Service TAM Summary Breakdown by Tier The TAM data is derived from our [...]

By |2020-09-25T19:26:00+00:00October 15th, 2019|Whitepapers & Market Reports|

Regulatory Software & Service Total Addressable Market Analysis (Summer 2019)

Regulatory Software & Service Total Addressable Market Analysis (Summer 2019) Study Overview for Premier Members This market report provides an independent 3rd party analysis to the regulatory landscape status, key trends and total addressable market (TAM) Software and Services Summary Breakdown by Tier Individual Solution Category Analysis The TAM data is derived from our [...]

By |2020-06-15T17:28:34+00:00October 14th, 2019|Whitepapers & Market Reports|