Changing a fragmented culture and non-standardized operating procedure that had resulted in higher than acceptable risk and poor time to market in a clinical trial program that spanned multiple global hubs on five continents.
Previous attempts to standardize had failed. We were asked to shape and execute the roll-out of a new process and enabling technology that, if successful, would fundamentally change our client’s clinical trial operations by improving communication and standardizing processes to lower risk and improve time to market.
We began by assessing the program scope and change readiness by region, country, business line, unit and function.
In our experience, this is the necessary first step to create a program that will result in sustainable change, so that the business can realize the benefits. We found that there was little sense of ownership of the standard practices in place, resulting in low adherence.
Based on this information, we integrated robust stakeholder communications and engagement into every aspect of the roll-out plan, which included landscape mapping, change impact assessment, benefits mapping and tracking, process definition and socialization, training needs analysis, training planning and roll out as well as testing and cutover.
Better Speed of Adoption than previous programs
Savings per Year
How we delivered these results:
The Chaucer teams quickly integrate with clients to ensure successful delivery. Chaucer provided SMEs in the key domain areas of Clinical Data, Regulatory, Safety and Regulated Document Management. Our Project Managers utilized our PMOFlex™ approach to ensure a right sized and cost effective solution. Delivered with rigor to ensure the integration of assets was carried out in a practical, fit for purpose and timely manner
With process rigor, e.g. GCP, and attention to quality to enable reproducible and monitored migration process with data that was ready for use in time for all key milestones reporting and regulatory commitments.
If you think we can help you to implement your project or programme strategy, please call us on: +44 (0) 203 141 8400 in UK/Europe, or +1 713 821 1783 in the USA.