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Nov 2, 2015

CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials, today announced a strategic collaboration with clinical trials business solutions consultancy, Widler & Schiemann Ltd. The collaboration will bring together CluePoints' award-winning RBM software with Widler & Schiemann's risk-assessment consulting expertise, to deliver a comprehensive solution that covers all elements of risk and quality management. From software implementation through to operational considerations and meeting regulatory requirements, the partnership will support customers in integrating all-inclusive RBM strategies within their clinical trials.

Artem Andrianov, Managing Director at Cyntegrity, Beat Widler, Managing Partner at Widler & Schiemann and María Proupín-Pérez, Project Leader at PPH plus interpret the new ICH E6 addendum’s implication on Clinical Development. Risk Management, Quality Management, Risk-based Monitoring and CRO oversight are the main topics. Read more at:

Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the regulatory agencies to minimize the potential for bias. This becomes especially critical when assessments are not based on measurable data but are derived from the interpretation of measurements, when they require the application of complex endpoint assessments, or when a study cannot be blinded. To make such interpretation more robust, a verification of (subjective) assessments by an independent panel of experts is frequently utilized. The objective of this paper was to analyze how often adjudicated methods across efficacy and safety assessments were used in drug approvals in the European Union and United States in 2013 and early 2014.

Ethical GmbH provides Software Solutions to manage the Clinical Endpoint Independent Review & Adjudication. Mimmo Garibbo also chairs the corresponding linked-in group on endpoint adjudication. The survey intends to find out about the current methodologies of endpoint adjudication, what issues designers of clinical trials face and how they could be resolved.