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Transforming a compound into a drug is a massive undertaking that can often take more than a decade. Each of the various phases of drug development, from discovery to final registration, brings its own challenges, such as the move from in vivo to human testing and monitoring of efficacy and safety. However, in all phases a structured process is mandatory for final commercial success.
MotivesThe clients motives for improving drug development systems are typically to improve productivity, minimise non-compliance incidents and ensure adherence to GxP and GAMP5 which will make FDA and EMA audits a breeze.
To achieve this you need an integrated IT strategy designed to support and optimise your entire clinical information supply chain. An eClinical analysis helps clarify how to create the most advantageous IT landscape and organise the crucial interfaces between people, processes and technology.
OfferingsOur offerings range from eClinical analysis, CDMS and CDW implementation, CDISC standardisation to Clinical Collaboration Platforms, then monitoring subsequent success.