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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.
Sep 2017

Generation of a Risk Report across Studies

By | 2017-10-10T17:05:02+00:00 September 18, 2017|Blog, Weekly RBM Feature|0 Comments

The RBM software EarlyBird® obtains a powerful and flexible system for ad-hoc reporting of risk-relevant data. It can be used to explore clinical data in more detail, prepare centralized monitoring reports, and build up a risk overview across studies. An example of such a [...]

Aug 2017

Predictive Analytics in RBM (cont.)

By | 2017-09-18T19:55:38+00:00 August 8, 2017|Blog, Library, RBM Product Updates, Weekly RBM Feature, White Paper|0 Comments

In our previous "predictive analytics in RBM" article, we started a discussion about algorithms of machine learning (ML), predictive analytics, and artificial intelligence. We also covered that a risk software needs to calculate forecasts of Key Risk Indicators (KRIs) proactively and alerts when they [...]

Aug 2017

Predictive Analytics in RBM

By | 2017-10-04T17:01:30+00:00 August 2, 2017|Blog, Library, Weekly RBM Feature, White Paper|0 Comments

Predictive analytics is a very useful tool in the risk-based monitoring and overall risk-based study management. It increases the proportion of correct decisions, as the decisions start being more data-driven. It also helps to understand for a central CRA or study manager the trending [...]

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 [...]

Apr 2017

Quality Tolerance Limits Video

By | 2017-05-10T20:04:09+00:00 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 | 2017-10-04T16:54:16+00:00 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 [...]