Cyntegrity's CEO Artem Andrianov to speak on the Germany ePharma day in Munich. The topic of the presentation is Practical methods how to master the new EU Clinical Trials Regulation with risk-based monitoring (RbM) See conference's program here. The event is focused on the new EU regulation [...]
Recent research shows, the size of sponsors correlates with the size of service providers. Big Pharma relies on the large, full-service CROs if they are running a large clinical trial. As the outsourcing world has always moved in cycles, today, there is [...]
On 15th of April 2015 Artem Andrianov speaks on 8th DIA Clinical Forum, which is conducted this year together with DIA EuroMeeting. The Annual Clinical Forum occurs this year on 14-15th of April 2015 in Paris, France. In comparison to DIA EuroMeeting, it is [...]
Webinar description: What risks does RbM introduce by itself? Why monitoring team does not accept the new RbM procedure? How should sites be involved in RbM process? Now, we can tackle these questions. We are going to review the definition of Risk-based Monitoring (RbM) in [...]
If not applied appropriately, Risk-based Monitoring could generate certain risks that influence data quality and patient safety inversely. Adopting an RBM approach involves more than applying some 'formula'. This white paper lists the 8 most common pitfalls of RBM implementation and expert suggestions on how to avoid them.
Case Study Clinical trial site engagement has been advocated as a critical component relating to a study’s performance and success, however, a minimum amount of data supports this connection. In this article a reader will find quantitative and qualitative approach based on risk-based [...]
In Applied Clinical Trials journal appeared an article, which investigates the question of site screening due diligence and how it can improve patient dropout rates - "RbM Data Reveals Site Screening Due Diligence Improves Patient Dropout and Retention". The investigations for the article were done applying [...]
Risk-based Monitoring jargon doesn’t require rocket science. You don’t have to be a statistician to analyse and interpret KPIs, KRIs and KQIs. We explain their meaning and differences through simple examples, so you can optimise key performance of your clinical trials.
Cyntegrity brings the innovative risk based monitoring technology to New York. Besides the Silicon Valley in California, New York City has become a real hot spot for innovation from around the globe. Alone New York has 1.5 times larger GDP comparing to Saudi Arabia [...]
Moe Alsumidaie, María Proupín-Pérez, PhD, Artem Andrianov, PhD, Beat Widler, PhD, Peter Schiemann, PhD, Johanna Schenk, MD, PhD Originally published on Applied Clinical Trials [link to the article]. Quality Risk Management (QRM), Quality by Design (QbD), Risk-based Monitoring (RbM), data driven monitoring or centralized monitoring [...]
