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+00:00September 18, 2017|Blog, Weekly RBM Feature|Comments Off on Generation of a Risk Report across Studies

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

Article at ACT: “Process Innovation in Clinical Trial Monitoring”

By |2017-10-04T17:03:31+00:00August 23, 2017|News|Comments Off on Article at ACT: “Process Innovation in Clinical Trial Monitoring”

Cyntegrity employees were happy to contribute to the new peer reviewed article in Applied Clinical Trials: "The PUEKS Project: Process Innovation in Clinical Trial Monitoring" http://www.appliedclinicaltrialsonline.com/pueks-project-process-innovation-clinical-trial-monitoring

Aug 2017

Predictive Analytics in RBM (cont.)

By |2017-09-18T19:55:38+00:00August 8, 2017|Blog, Library, RBM Product Updates, Weekly RBM Feature, White Paper|Comments Off on Predictive Analytics in RBM (cont.)

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 |2018-10-08T07:31:04+00:00August 2, 2017|Blog, Library, Weekly RBM Feature, White Paper|Comments Off on Predictive Analytics in RBM

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+00:00June 14, 2017|News|Comments Off on ICH GCP Addendum E6 R2 comes into operation!

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 [...]

May 2017

Press Release: Cyntegrity partners with Sollers Institute

By |2017-05-09T13:26:09+00:00May 9, 2017|News|Comments Off on Press Release: Cyntegrity partners with Sollers Institute

25.04.2016. Cyntegrity, cloud solution provider for the efficient Risk-based Monitoring (RBM), is pleased to announce its partnership with Sollers Institute (New Jersey, US). Sollers is the leader in training related to the clinical research, drug safety, and pharmacovigilance, providing the premium education according to [...]

Apr 2017

Quality Tolerance Limits Video

By |2017-05-10T20:04:09+00:00April 19, 2017|Blog, Webinar|1 Comment

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+00:00March 31, 2017|Blog|Comments Off on On what stage of RBM evolution is your company? There are four main stages…

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 [...]

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