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.
May 2018

Key Risk Indicators Reveal Blind Spots in Clinical Trials

By |2018-05-16T09:02:30+00:00May 15, 2018|Blog|0 Comments

By design, the traditional spot-checking type of audits leave a blind spot on systemic quality threats. Key Risk Indicators however, form the core of a widely applicable concept that captures all relevant risks in scope and provides project managers and QM experts targeted and objective updates on actionable issues and trends.

Mar 2018

A Simple 5-step Plan to Improve Quality and Efficiency in Clinical Trials

By |2018-03-16T12:10:26+00:00March 2, 2018|News|0 Comments

Last February 28th, the FDA finalized the E6 (R2) version of the addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline. What to do now? Don’t panic, we’ve put together a simple 5-step plan to help you initiate the most urgent process adaptations.

Feb 2018

Press Release: Cyntegrity Rolls out SaaS Application to Help Pharma Organisations Bring Regulatory Guidance into Practice

By |2018-02-27T13:18:32+00:00February 27, 2018|News|0 Comments

Frankfurt – Cyntegrity, a German provider of proprietary Risk-based Monitoring (RBM) cloud services for the Life Sciences industry, today announced the rollout of “@RACT-Pro” – simple and affordable risk assessment and mitigation tool. There is even a free version. This online SaaS (software as [...]

Feb 2018

What is the Cost of Poor Quality in Pharma?

By |2019-02-27T12:06:30+00:00February 20, 2018|Blog, Infographic, Library|0 Comments

Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.

Nov 2017

Cyntegrity’s CEO Presents at MCC: Process Innovation in Clinical Trial Monitoring

By |2017-11-16T19:34:11+00:00November 16, 2017|News|0 Comments

Dr. Artem Andrianov, the Cyntegrity's CEO, will be presenting on the recent publication in Applied Clinical Trials at MCC's next meeting on 11-Dec-2017 at 10am EST. Registration link below. The link to the peer-reviewed Applied Clinical Trials article: Registration (for MCC members only): [...]

Sep 2017

Generation of a Risk Report across Studies

By |2017-10-10T17:05:02+00:00September 18, 2017|Blog, Neat Features|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+00:00August 8, 2017|Blog, Library, Neat Features, RBM Product Updates, 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 |2018-10-08T07:31:04+00:00August 2, 2017|Blog, Library, Neat Features, White Paper|1 Comment

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|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 - PDF Mindmap of all GCP E6 R2 changes - ICH GCP Goes Risk Based - a [...]

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