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 [...]
Click here for downloading the PDF version. Based on the source: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
As RBM is its infancy, it is vital to understand how to measure its success, so that we all would have a chance to reflect and correct our path if needed. An interest of adding an RBM technology to clinical trials emerges in pharmaceutical companies [...]
The Webinar conducted by Andy Lawton (Global Head of Data Management at Boehringer Ingelheim) and Ellen Kelso (Executive Director at Chesapeake IRB)
On 6th May 2016, a draft guideline of the International Council on Harmonisation (ICH) “General Principles for Planning and Design of Multi-Regional Clinical Trials” was published, the aim being to make global multinational clinical trials safer and more trustworthy [1]. ICH advises applying a [...]
Which elements must a Risk-based Monitoring (RBM) plan must contain? What are the sponsor responsibilities regarding clinical monitoring? What kind of monitoring methods does the FDA suggest? To answer these questions, please, explore the MindMap of the "Guidance for Industry. Oversight of clinical Investigations - A [...]
[videojs width="640" height="480" mp4="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_Step_2_audio.mp4"] Source: http://www.ich.org International Council for Harmonisation (ICH) first time since 17 years is undertaking ground-shaking changes to Good Clinical Practice (GCP) guidelines. These changes take effect on November 1, 2016. In the 22 minute video above it is described how the new [...]
If I would summarize innovation in Healthcare, I would say, “We dreamed about flying cars and got 140 characters”. The recent Health 2.0 conference in Barcelona (May 2016) has confirmed my feelings. Innovation in healthcare struggles to persuade all major stakeholders: doctors, insurance companies, researchers, [...]
In order to stay informed about the latest RBM trends, visit RBM-relevant conferences. What RBM-relevant conferences are coming in 2016-2017? For your convenience, please, see below an event calendar with the major RBM conferences. Enjoy! (The direct link to the calendar is here.) [...]
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 [...]
