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Jun 2017

ICH GCP Addendum E6 R2 comes into operation!

By | 2017-06-14T09:35:40+00:00 June 14, 2017|News|0 Comments

Today the ICH GCP Addendum E6 R2 comes into operation. Therefore, we summarized the useful resources for your kind perusal: GCP E6 R2 Addendum itself - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf PDF Mindmap of all GCP E6 R2 changes - https://cyntegrity.com/ich-gcp-addendum-e6-r2-mind-map-pdf-for-download/ ICH GCP Goes Risk Based - a [...]

Nov 2016

ICH Finalized GCP Addendum E6 Revision 2

By | 2016-11-18T16:59:14+00:00 November 18, 2016|News|0 Comments

The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted [...]

Nov 2016

WHO Guideline on Good Data and Record Management Practices is Final

By | 2016-11-16T18:35:27+00:00 November 9, 2016|News|0 Comments

The WHO guideline on Good Data and Record Management practices is now final, below you find the link. Particularly interesting is that this guideline talks about quality risk management: Quality risk management and sound scientific principles. Robust decision making requires appropriate quality and risk management [...]

Sep 2016

Andy Lawton, a leader in TransCelerate’s RBM initiative joins Cyntegrity

By | 2016-11-16T18:35:29+00:00 September 22, 2016|News|0 Comments

Andy Lawton, a top expert with 35+ years of experience in clinical trials in the areas of biometrics, data management programming, system development, computer system validation and risk-based approach, joins Cyntegrity as RBM Advisory Board Member.  As the global lead of Clinical Data Management at [...]

Aug 2016

A new RBM Sandbox is Released (Ver. 4.0)

By | 2016-11-16T18:35:30+00:00 August 9, 2016|News|0 Comments

Do you want to try RBM on practice? Still confused by many offers and companies? Do you want to decide yourself based on objective evidence? Apply and test our newest RBM demo environment. Explore the holistic RBM process and get a feeling how technology could [...]

Jun 2016

Press Release: Synergy and Cyntegrity announce partnership to foster RBM practicality

By | 2016-11-16T18:35:32+00:00 June 22, 2016|News|0 Comments

21.06.2016. Synergy, Russian fastest Contract Research Organization (CRO) and Cyntegrity, a German technology provider for efficient Risk-based Monitoring (RBM), are pleased to announce a partnership, in order to foster the practicality of RBM. Nowadays, the advantages of RBM compared to the traditional monitoring model are [...]

May 2016

Johann Proeve, Ph.D., strengthens Cyntegrity as CSO

By | 2016-11-16T18:35:32+00:00 May 24, 2016|News|0 Comments

J. Proeve, Ph.D., an expert with 35+ years of experience as Global Data Management Head at Bayer started this week as Chief Scientific Officer at Cyntegrity. He takes the responsibility of building up a proper Risk-based Monitoring (RBM) strategy for each clinical study and develop further Cyntegrity's core product RBM [...]