The introduction of the ICH E6 (R2) addendum means that taking a risk based approach (RBA) within a sponsor is no longer an option but a requirement.
In selecting a system to meet the RBM aspects of a clinical trial, there are four main areas that have to be addressed in the sponsors’ system landscape:
- Risk identification
- Risk monitoring
- Issue management
- Data integration
This webinar will focus on data integration. At the earliest stage of the draft guidances from the FDA and EMA on RBM, they identified that the silo’d nature of the sponsor was often a key issue. A silo’d organisation structure, is all too often also represented in the data availability. The first requirement is to have access to all the necessary data and the second is to be able to integrate them.
So why is data integration so important? Data integration brings to life risks that are not apparent when you examine the data from one source alone, examples shown will include eCRF and audit trail, CTMS, Drug Safety database, etc. As we gain more knowledge about risk then using additional data sources becomes more common.
Andy Lawton, Advisor, Risk Based Approach Ltd.
Andy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, RBA in CSV and clinical trials. He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim where he also held positions of increasing responsibility during his 30 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publication is the paper with Dr. Alistair Ross on GP Audit – throughout 80’s and 90’s this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA for the TransCelerate papers on SDV and central monitoring in the TIRS Journal.
Pankaj Manon, CTO, ThoughtSphere
Prior to founding ThoughtSphere, Pankaj was the global CTMS lead for the largest CRO in the world, Quintiles, handling customer demand and solution delivery across all product verticals. He also has experience in large pharmaceutical, life sciences, and biotechnology companies, as well as project management and solution architecture roles with Oracle’s North America consulting organization. Pankaj has a Master’s in IT Business Administration and advanced systems diploma from National Institute of Information Technology (NIIT).
Who Should Attend?
Senior level executives involved in:
- Clinical Operations
- Clinical Data Management
- Central Monitoring
- Risk-based Monitoring (RBM)
- IT (Clinical)
Founded by clinical information and technology industry experts with over 30 years of experience from the leading global CRO and eClinical providers, ThoughtSphere’s mission is to streamline and empower the clinical trials process by eliminating the two biggest challenges–integration of disparate clinical and operational data and making it accessible for use with existing tools for analytics and visualization. With this innovative platform, biopharma, medical device sponsors and CROs can reduce and optimize clinical development costs, aggregate operational and clinical data to enhance efficiency and effectiveness in the clinical trial processes and gain near real-time actionable insights. The product suite includes ClinDAP, the source-system agnostic next-generation data integration platform; ClinACT, the interactive visualization and analytics platform that enables RBM and CRO Quality Oversight; and SPACE, the integrated site budgeting, payments and contracting solution. At ThoughtSphere, we believe we can deliver on the promise of big data to drive health innovation. For more information, visit http://www.thoughtsphere.com/.
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