How we got our teams to speak the same language
Data Management (DM) and Clinical Operational teams must work hand in hand to properly execute the capture, management, and monitoring of clinical data throughout the entire life cycle of a study; however, the use of different systems, processes, and datasets makes close and effective collaboration a challenge. PROMETRIKA has been partnered with Medidata for over 10 years, and we have standardized our clinical operations and data management technology utilizing their unified data platform. However, we apply the same strategies to bring DM and Clinical Operations into the workflow for any DM platform utilized. An integrated workflow allows DM and other teams to “speak the same language” throughout a study and work together in real-time which, in turn, leads to decreased risk, higher quality data, and ease of collaboration between teams by providing ‘actionable intelligence’ to the key decision makers in both teams.
As a full-service CRO, PROMETRIKA brings our teams together beginning at study start-up when Clinical Operations, Data Management, Biostatistics, and Pharmacovigilance work together on eCRF design. Involving the operational teams early is critical to ensure the eCRFs account for all the data capture requirements as directed per the study protocol. Additionally, the IVRS/IWRS, ePRO, CTMS, eTMF, Medical Imaging and other modules are all designed and built at the same time as the EDC which ensures that all involved teams have a solid understanding of the systems and how data will be handled. As much as is possible, everything is brought into a unified platform to make it possible to complete UAT and resolve questions involving multiple teams within a minimum number of applications, both at start-up and throughout the life a study. Beyond the database, all relevant operational teams have input on key documents that determine how data will be collected and monitored. These include, but are not limited to, study-specific eCRF completion guidelines, data management plan, data validation specifications, and risk management plan.
Once start-up is complete and the study has launched “Go-Live”, we continue to reap the benefits of unifying data platforms and PROMETRIKA’s team approach. With all data flowing into a single database repository, it is possible for team members to review it with a single login rather than jumping between applications to piece together the whole picture. Training for users can be streamlined as well if there is only one platform, since all training is completed and tracked within it, saving time and money. If post-production changes are required, the operational teams are able to rapidly assess the impact of changes and proactively mitigate any associated risks since they have been involved in the design of the eCRFs and database from the beginning.
Of course, a clinical study is not a “set it and forget it” affair, and monitoring its progress throughout is critical to a successful outcome. Having a minimum number of platforms in which data can be reviewed, eCRFs monitored, queries managed, and protocol deviations captured allows for better communication between data management, clinical operations, site monitor, and site staff. PROMETRIKA also works toward unifying data platforms as much as possible, so we can more easily generate the metrics needed to routinely assess the key risk indicators noted in the risk management plan which allows us to centrally monitor the overall health and status of the study. Streamlined access to these metrics makes monitoring more efficient and less error prone, improving the study’s data quality.
During the intense study close-out phase, there is a push to ensure that all necessary data is entered, cleaned and locked, study drug supply is reconciled, and other data operational requirements are addressed as quickly as possible. Again, unifying data platforms allows our team to more easily generate and share reports of what data and tasks remain outstanding. This, in turn, allows us to collaborate more effectively with monitors, investigators, site staff and other operational teams which contributes to more efficiently locking the database and closing-out the study.
Ultimately, we believe that close communication and collaboration between teams, internal and external, are fundamental to a successful study. Generating a unified data platform is an outgrowth of this mindset and provides us the tools to make collaboration easier and more efficient, and PROMETRIKA works with our sponsors to decide which tools are the best fit for their studies.