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So far Gens Associates has created 78 blog entries.

2023 Optimizing Affiliate Engagement Regulatory Survey Whitepaper

2023 Optimizing Affiliate Engagement Regulatory Survey Whitepaper This White Paper reviews the key findings from 320 local affiliates representing 94 countries that participated in our study during the summer of 2023. The study was designed to capture and examine the “voice of the affiliate” to improve global regulatory activities. The paper reviews [...]

By |2024-01-08T18:46:07+00:00January 8th, 2024|Whitepaper|

Optimizing Affiliate Engagement is a Key Step for the Last Mile

You may have heard of the saying to ‘treat feedback as a gift’. If so, then our latest study feels like a gift that keeps on giving. Our 2023 Optimizing Affiliate Engagement to Improve Performance of Key Regulatory Activities survey is a landmark study designed to capture the voice of the affiliate. As most life science companies want to be better and get better at managing key regulatory information on a truly global scale, improving how affiliates work and how headquarters interacts with and supports those affiliates are critical components.

By |2023-11-19T22:43:51+00:00November 19th, 2023|Blog|

Gens & Associates launches latest World Class RIM study

Gens & Associates launches latest World Class RIM℠ study – the largest yet – to define & hone “industry standard” practice Stakeholders across the global Life Sciences industry & regulatory provider community are invited to play their part in cementing the ultimate approach to regulatory information management Newtown, Pennsylvania, USA – October 4th, [...]

By |2023-10-04T11:49:41+00:00October 2nd, 2023|Press Releases|

Improving Data Quality by Establishing Good Governance Practices

Improving Data Quality with better Data Governance cross-functionally is a “hot topic”. Companies are investing in people and technology to get more out of their information assets, realising this through large system and process modernization, plus the ability to connect data across functions, and the bottom line is “the quality of information in systems has to improve - period”. Great things happen when there is high confidence in the information we use as regulatory professionals every day – speed, better decisions, efficiency, and trust.

By |2023-09-12T16:10:06+00:00September 12th, 2023|Blog|

Regulatory Consolidation

It’s been an interesting 12 months to say the least with ArisGlobal buying both Amplexor and SPORIFY, Ennov buying Samarind, Calyx divestiture from PARAEXEL only to be acquired by CapVest/GLO Healthcare in Q1 2023, and Honeywell buying Sparta Systems. We also witnessed some successful partnerships, especially the combined Generis/Extedo capabilities in both systems and services.

By |2023-07-12T16:53:04+00:00July 12th, 2023|Blog|

Regulatory Intelligence 2022 Study Whitepaper

Regulatory Intelligence 2022 Study Whitepaper This 10-page whitepaper summarizes the learnings from the December 2022 Regulatory Intelligence Pulse Survey of 42 organizations representing industry and 13 regulatory software providers. The paper is structured by: Introduction and Executive Summary Study Background Regulatory Intelligence Model and Department Remit Automating [...]

By |2023-05-01T15:55:05+00:00May 1st, 2023|Whitepaper|

2023 Regulatory Software Provider Market Report Update with TAM

2023 Regulatory Software Provider Market Report Update with TAM This version of the regulatory software market report provides an independent 3rd party analysis of the regulatory software provider landscape status, key trends and total addressable market (TAM) including: Software Provider Market Share, Customer Satisfaction, and Innovation Index 2016 – 2022 Submission Content Management [...]

By |2023-05-01T16:01:12+00:00May 1st, 2023|Whitepapers & Market Reports|

Mastering the Art of Measurement – Drive Performance when Mere Reporting is not Enough

Imagine a world where metrics can identify issues before they occur, where forecasts are accurate, and stakeholders can perform effectively and grow in their jobs thanks to full process transparency. And imagine that these dashboards are automatically populated, forecasting models automatically updated, periodic reports automatically generated, and issues automatically identified and reported. We need not rely upon artificial intelligence, simply using the data and metadata within our systems (see figure below) can provide the insights to effectively manage and continuously improve regulatory performance.

By |2023-03-27T17:25:07+00:00March 27th, 2023|Blog|

Optimizing Local Regulatory Affiliate Engagement – Embarking on New Research

A key headline from the 2022 WCRIM Study highlights the need to optimize engagement at the affiliate level in order to ‘solve the last mile’ in terms of achieving global RIM operational performance, high data confidence levels, quality, and compliance. Because of all these high value components, we know this is an important topic for many organizations.

By |2023-03-13T16:54:50+00:00March 13th, 2023|Blog|