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Artem

About Artem Andrianov, Ph.D., MBA

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.
Jun 2017

ICH GCP Addendum E6 R2 comes into operation!

By | 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 [...]

Apr 2017

Quality Tolerance Limits Video

By | April 19, 2017|Blog, Webinar|0 Comments

Video from our recent CyntegrityEDU Webinar - ICH E.6(GCP) Addendum Quality Tolerance Limits Part 1. ICH E6 background (Structural & Non-structural) Quality Tolerance Limits (QTLs) Brief history of QTLs How to use the QTLs Potential benefits Part 2. Technology consideration of QTLs Considerations of enabling [...]

Mar 2017

On what stage of RBM evolution is your company? There are four main stages…

By | March 31, 2017|Blog|0 Comments

Four stages of RBM Evolution in a Pharma Company Intelligent software systems are facilitating the data accumulation in clinical trials already. The 75% of clinical trials are conducted with the Electronic Data Capture (EDC) [1]. The next step is to unfreeze the knowledge of [...]

Mar 2017

4 Most Common RBM-related Audit Findings

By | March 2, 2017|Blog|0 Comments

Picture source: http://independentaudit.com/tweeting-audit-findings-colour/ How to avoid audit findings in Risk-based Monitoring (RBM) and risk management environment? What are the most common findings in RBM? What are auditors looking for in risk management plans, SOPs and RBM guidance? If we can imagine a pharma hell, this [...]

Dec 2016

Video from the Webinar “Risk-based Monitoring for Clinical Research Leaders”

By | December 20, 2016|Blog|0 Comments

The new Risk-based Monitoring concept reforms the clinical monitoring and clinical trial management. Risk factors become an important component there. What does it mean for a pharmaceutical company? Clinical trial risks are easy to foresee, site level risks and operational risks are hard to [...]

Nov 2016

ICH Finalized GCP Addendum E6 Revision 2

By | 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 | 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 [...]