A mid-sized pharma client needed to establish a data transparency team to manage anonymization projects in compliance with EMA Policy 070 and Health Canada regulatory requirements. Having no formal policies and processes yet in place, they looked to GenInvo as an established expert in data transparency and an industry leader in data and document anonymization solutions to meet their objectives.
GenInvo’s Solutions Analysts worked collaboratively with the client’s project stakeholders to establish a data transparency implementation plan. Initial training was provided to get the team familiar with regulations, general requirements and anonymization techniques. GenInvo’s Expert Determinators and Anonymization Team members generated standard operation procedures, working instructions and associated documents to cover the client’s data transparency activities inclusive of management of external providers of anonymization services. To test these processes, GenInvo’s Anonymization Team executed proof of concept projects in compliance with the newly established processes, evaluating and adjusting as-needed after each stage. Once finalized, GenInvo produced training materials and provided a final round of training with associated videos and quizzes to their newly established Data Transparency team via their internal learning system.
The client is now able to confidently manage their own data transparency processes and has a trusted partner they can rely on to address any new data transparency requirements and for ongoing support of anonymization projects.