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• Our core customers are CROs and Pharma companies who want to run ICH E6 (R2) compliant trials in
an efficient and cost effective manner.
• ICH E6 (R2) has already been adopted in EU, will be adopted by Canada in April 2018 and is expected
to be adopted by FDA during 2018.
• We provide all the technology and services required to enable ICH E6 (R2) compliance and central or
risk-based monitoring with no client infrastructure required.
• We support our customers in preparing for R2, ensuring a fast and effective adoption of the new
guidance.
• We support our customers in running trials in accordance with the new R2 processes, such as protocol
risk assessment and quality management planning, in order to ensure R2 compliance and complete
peace of mind.
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