What are the most common risks in clinical trials? What challenges faces TransCelerate RACT? Read the answers in the latest article published on ACT. by Moe Alsumidaie, Beat Widler, PhD, Peter Schiemann, PhD, Artem Andrianov, PhD Do you want to know about @RACT more and start [...]
What is the formula of clinical trial success? Performance is hard to sustain and risks are emerging unexpectedly. The goal of this article is to define a robust methodology for managing performance and risk in clinical trials. by Dimitri Stamatiadis, PhD, MBA Why measure performance? You [...]
The majority of companies are delaying the RBM adoption. Why? The reason lies now in the nature of innovation adoption. The main hesitations of the pragmatists to apply RBM nowadays are connected with: the general complexity of the approach the perceived risk of audit findings [...]
Interview with Artem Andrianov during PCT 2015: What Pharma Gains from Structured RBM?
What SDV is really for? How it develops and to what form it evolves? What is the future role of a CRA? This article depicts a role of SDV in a clinical monitoring process, shows the path of [...]
A famous saying tells us that “experience often comes after one needs it”. Risk-based monitoring (RBM) is a major development and often fails in implementation due to its additional complexity and the variety of opinions of various stakeholders. In order to gain experience before one needs [...]
The film unites Risk-based Monitoring (RBM) experts from a sponsor side, contract research organization, strategic advisers and technology providers. The experts provide outlook for Risk-based Monitoring for 2016: Dr. María Proupín-Pérez, PMP - Project Leader (PPH plus) Dr. Peter Schiemann - Managing Partner (Widler & Schiemann Ltd.) Moe [...]
Christmas time is a time of miracles and the largest miracle is to open your heart to help. Who needs your help the most? Those who cannot live without it even a day. 25-th of April 2015, Nepal. In the morning, when all parents were at work and [...]
TransCelerate RACT offers a very useful methodology for study level risk assessments. Despite its standardized character and broad study risk scope, the RACT has some weaknesses. The way to address these common spreadsheet shortcomings is the deployment of dedicated technology together with a specialized user interface presenting the trial risks in a logical manner.
Photo by: Dave Granlund Data integrity is the fundamental property of any information. In its original meaning, data integrity refers to consistency and accuracy both within itself and in the context of real life. Today, we make many decisions based on captured data, and we [...]
