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Clinical Outsourcing Strategies
8 November 2016, 10.30 am CET
Webinar Title: Site Monitoring in the Brave New World of RBM – the new Cra EXperience
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8 November 2016, 10.30 am CET
Site Monitoring in the Brave New World of RBM – the new Cra EXperience
RBM has been a topic of conversation for several years now. In theory this is all nice to hear but how is this put into practice. What does this actually imply for the Clinical Research Associate? How do we implement a RBM approach in real life for a CRA? With implementing an RBM approach we are looking at a New Cra EXperience. We are confronted with new skills, new processes and new technologies. This means facing new challenges and one of these is how monitors were trained over the past 10 years; changing their attitude and birds eye view. New monitor training is needed to support building this new CRA experience. Monitors are often asked to decrease their SDV but without communication on how oversight will be conducted/maintained. Simply eliminating the SDV process and not replacing it by remote oversight, is not complying with FDA and EMA’s guidance documents. Monitoring a trial involves many team members with different responsibilities and skill sets. RBM activities mean that all members of this team need to work together. Communication is an essential skill that will be taking the lead in this new Cra EXperience. Together with RBM approach, we do not only want to have an oversight, better quality and a better cycle time but also an icrease in efficiency. To meet this latter metrics we introduced a new line function in our centralized team: the CRA Liaison. The CRA Liaison is providing the remote support to the CRA to enhance an increase in quality, oversight and efficiency on site. With the CRA Liaison we can say that the CRA role can be changed into what it initially was planned to be: The tasks of the CRA is to monitor a clinical trial. Monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded and reported in accordance with protocol, SOPs, GCP and the applicable regulatory requirements (ICH E6).
Sabrina Wijnen, Managing Director, Clinitude
Sabrina Wijnen is the founder and Managing Director of Clinitude, a no-nonsense CRO known for its pragmatic clinical monitoring services and broad regulatory experience.
Prior to devoting her work fulltime to build Clinitude, Sabrina was active in clinical research for several years with respected international CRO’s, resulting in more than 14 years of experience in managing European studies and a deep familiarity with all phases of clinical development. Early 2006 Sabrina founded Clinitude to service the Belgian market with high quality monitoring and project management services. Not much later the services were expanded to other European countries, additionally Clinitude has build an extensive understanding of European regulatory requirements.
In 2014 Sabrina Wijnen started Clinitude’s Asian Clinical Operations with a permanent offshore team in the Philippines and Singapore to service the surrounding countries.
In 2016 Sabrina Wijnen introduces Clinitude’s latest product, the ‘CRA Liaison’, to redefine the traditional CRA role with a highly efficient new approach to increase the efficiency and quality of the traditional CRA on site.
Clinitude is a privately owned CRO with more than 10 years of experience, specialized in cross-border clinical research consultancy with in depth experience in submitting and conducting clinical trials in Europe and Asia.
Handling the diversity and complexity in local laws and regulations for each country is one of our expertises. Clinitude is unique in an environment where delays and cost overruns are considered normal, while we guarantee a cost effective efficient timely approach with our new CRA liaisons. Our game changer attitude has resulted in tailored solutions centralised around our head offices in Belgium, Singapore, the Philippines and US.