About Artem Andrianov, Ph.D., MBA

Professional in the integration of data-driven Risk-based Quality Management (RBQM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, Health 2.0, DGGF, etc. 18+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RBQM research to new frontiers for CROs, pharma and biotech companies.
Oct 2021

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2021-10-19T07:04:49+00:00October 17, 2021|Blog, Free Infographics|0 Comments

The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.

Sep 2020

FDA Concerned About Statistical Power COVID-19 Impacted Clinical Studies

By |2020-09-29T05:40:58+00:00September 10, 2020|Blog|0 Comments

Checking and maintaining trial integrity, and proactively adjusting trial analysis strategies to ensure trial data validity, are the FDA's two key areas of concern.

Jul 2019

Video | Improving the Implementation of RBM – Workshop at Duke Margolis

By |2019-09-12T15:11:21+00:00July 23, 2019|News|0 Comments

The workshop at Robert J. Margolis Center for Health Policy at Duke University was to capture stakeholder input on the challenges, barriers, and enablers to implementation of Risk-Based Monitoring (RBM). The workshop also reviewed stakeholder experiences with RBM adoption and opportunities to improve [...]

Jul 2019

A Clinical Research Must-Have: Next Generation Predictive Analytics

By |2020-05-15T10:29:37+00:00July 8, 2019|Blog|0 Comments

Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry. 

May 2019

Centralized Monitoring: a Greater Advantage to a Broader Range of Trials

By |2019-07-19T14:05:06+00:00May 2, 2019|Blog, Free Infographics|0 Comments

Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...

Apr 2019

RBQM Software Features: What’s a Risk Flower chart?

By |2019-08-07T19:11:02+00:00April 9, 2019|Blog, Neat Features|1 Comment

Neat Features: wanting to dig a little deeper into the neat software features that make your risk-management life easy? Well, you’ve come to the right place. Learn more about Risk Flowers charts - a bunch of information.

Jan 2019

Quality Tolerance Limits versus Key Risk Indicators, The Difference

By |2020-02-05T07:40:21+00:00January 18, 2019|Blog, Free Infographics|1 Comment

To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.

Nov 2018

Patient Profiles – Better Understand Your Patients

By |2020-09-30T13:30:42+00:00November 1, 2018|Blog, Neat Features, RBQM Product Updates|0 Comments

Pharma today embraces the concept of patient-centered research. Innovators view Patients as informed collaborators whose participation is core to the overall success of clinical research. The risk-based Patient Profiles tool is a key contributor to the modern concept of patient-centered thinking, as It enables early detection and real time control of patient safety issues.

Upcoming Events

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    October 28 @ 4:00 pm - 5:00 pm UTC+0
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    December 2 @ 5:00 pm - 6:00 pm UTC+0

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