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.
Nov 2018

Patient Profiles

By |2018-11-01T20:12:36+00:00November 1, 2018|Blog, RBM Product Updates, Weekly RBM Feature|Comments Off on Patient Profiles

I Am Your Patient But Do You Know Me? Patient-centered R&D in pharma begins with understanding the patients, and Patient Profiles is the feature that enables that. The Patient Profile allows the oversight of the study-relevant parameters for all patients of a study. It [...]

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 |2018-04-05T15:16:39+00:00February 20, 2018|Blog, 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.

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|Comments Off on Cyntegrity’s CEO Presents at MCC: Process Innovation in Clinical Trial Monitoring

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: http://www.appliedclinicaltrialsonline.com/pueks-project-process-innovation-clinical-trial-monitoring Registration (for MCC members only): https://metricschampion.webex.com/metricschampion/j.php?RGID=r606bfad2af43d9dcd6c74b1eb9b80ff7 [...]

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

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