We’re thrilled to announce that CluePoints is now offering a complimentary Risk-Based Monitoring strategy Check-up and Risk Management review, aimed at helping sponsors and CROs accelerate their path to successful Risk-Based Monitoring adoption.
Steve Young, Senior Vice President of US Operations for CluePoints, will leverage his twenty plus years of industry experience to help companies identify how they can best implement a Risk-Based Monitoring strategy that meets ICH E6 Rev 2, FDA and EMA recommendations.
The resulting feedback will include a gap analysis that reinforces what is working well and recommendations on opportunities for further optimization. ICH E6 Rev 2 – which is due to come into effect before the end of this year, insists that sponsors have a documented plan to identify and mitigate operational risks – Steve will address this critical item as a part of the overall Risk-Based Monitoring review.
Steve’s credentials in the area of Risk-Based Monitoring are unrivaled, with experience both sponsor and vendor side in leading initiatives with Johnson & Johnson, Medidata, and TransCelerate defining successful Risk-Based Monitoring strategies.
This complimentary review is simple and pain-free and is an ideal opportunity to discuss your strategy, plans and current situation with a thought leader who has been responsible for advising sponsors on what’s required to deliver Risk-Based Monitoring and Risk Management success for organizations.
Send an email to [email protected] to schedule your complimentary review!