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.
Mar 2019

RBM / RBQM Case Studies

By |2019-03-20T09:33:43+00:00March 20, 2019|Blog, Case Study|Comments Off on RBM / RBQM Case Studies

1. Permissible Clarifications After checking the audit trail for those who entered the data, the RBQM system revealed that at two sites in Japan, instead of site personnel, the sponsor company monitor entered the majority of the data into the EDC system [...]

Jan 2019

Quality Tolerance Limits versus Key Risk Indicators, The Difference

By |2019-01-25T08:26:29+00:00January 18, 2019|Blog, Infographic|Comments Off on Quality Tolerance Limits versus Key Risk Indicators, The Difference

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

Are Clinical Trials Safe? 6 Questions to Ask Before Enrolling

By |2018-11-27T16:53:22+00:00November 27, 2018|Blog|Comments Off on Are Clinical Trials Safe? 6 Questions to Ask Before Enrolling

If you are thinking about joining a clinical research study, then you might wonder about the safety risks you should be aware of, as no clinical trial is completely safe for everyone.

Nov 2018

Patient Profiles – Better Understand Your Patients

By |2018-11-20T10:25:21+00:00November 1, 2018|Blog, RBM Product Updates, Weekly RBM Feature|Comments Off on Patient Profiles – Better Understand Your Patients

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.

Nov 2018

SCOPE Europe Summit 2018 – Reflection

By |2018-11-01T14:05:20+00:00November 1, 2018|News|Comments Off on SCOPE Europe Summit 2018 – Reflection

Zooming in on three key areas; analytics-driven feasibility, patient-centric enrolment planning and Risk-based Monitoring, SCOPE Europe professionally facilitated high level discussions between pharma industry leaders and decision makers.

Jul 2018

Press Release: Cyntegrity enters the Medical Devices Market

By |2018-07-16T13:34:34+00:00July 10, 2018|News|Comments Off on Press Release: Cyntegrity enters the Medical Devices Market

Cyntegrity today announced the worldwide release of their Medical Device RACT, “MD-RACT”, the world’s first Risk Assessment and Categorization Tool for clinical investigations, that combines the best practices in Life Sciences with subject matter expertise in Medical Devices.

May 2018

Key Risk Indicators Reveal Blind Spots in Clinical Trials

By |2018-05-16T09:02:30+00:00May 15, 2018|Blog|Comments Off on Key Risk Indicators Reveal Blind Spots in Clinical Trials

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|Comments Off on A Simple 5-step Plan to Improve Quality and Efficiency in Clinical Trials

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

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|Comments Off on What is the Cost of Poor Quality in Pharma?

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.

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