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Aug 2017

Predictive Analytics in RBM (cont.)

By | 2017-09-18T19:55:38+00:00 August 8, 2017|Blog, Library, RBM Product Updates, Weekly RBM Feature, 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 | 2017-09-18T19:54:12+00:00 August 2, 2017|Blog, Library, Weekly RBM Feature, White Paper|0 Comments

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 [...]

Apr 2017

Quality Tolerance Limits Video

By | 2017-05-10T20:04:09+00:00 April 19, 2017|Blog, Webinar|0 Comments

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 | 2017-08-03T19:51:03+00:00 March 31, 2017|Blog|0 Comments

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 [...]

Dec 2016

Video from the Webinar “Risk-based Monitoring for Clinical Research Leaders”

By | 2016-12-20T19:48:09+00:00 December 20, 2016|Blog|0 Comments

The new Risk-based Monitoring concept reforms the clinical monitoring and clinical trial management. Risk factors become an important component there. What does it mean for a pharmaceutical company? Clinical trial risks are easy to foresee, site level risks and operational risks are hard to [...]

Nov 2016

RBM: innovation or just common sense?

By | 2016-11-24T10:01:15+00:00 November 24, 2016|Blog|0 Comments

The article covers the topics of clinical trial budgeting when applying the risk-based monitoring (RBM) model. The problem is that the new monitoring model requires a new model of clinical trial budgeting too, while today, the common practice is to apply traditional fixed-price budgeting. [...]

Nov 2016

The Emergence of a “Risk Monitor”: Preparing for the future.

By | 2016-11-16T18:35:28+00:00 November 9, 2016|Blog|0 Comments

Pharmaceutical companies and contract research organizations (CROs) are increasingly trying to leverage technology to optimize risk-based monitoring. While technology is a critical component, roles also need to be looked at again. Recently we interviewed Dr. Nimita Limaye, an expert in risk-based monitoring, about the future [...]

Oct 2016

FDA Guidance – Oversight of Clinical Investigations an RBM Approach to Monitoring (Infographic)

By | 2016-11-16T18:35:28+00:00 October 26, 2016|Blog|0 Comments

Click here for downloading the PDF version. Based on the source: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf