Throughout the 17 years that PROMETRIKA has offered Clinical Operations services, our goals have been to streamline and maximize efficiency in clinical trials and provide trial management transparency to our sponsors. We have steadily enhanced and integrated our trial data collection and management systems to achieve a fully integrated platform that will provide seamless coordination of EDC, CTMS, and eTMF data.
Full integration of clinical operations software saves time and reduces the probability of error at multiple steps in data collection and in the administrative activities of running a trial. At the site level, personnel enter participant data in the EDC. PROMETRIKA’s clinical research associates (CRAs) and data managers (DMs) have immediate access to these data and examine them for logical inconsistencies or incorrect/implausible values. Our team specifically searches for trends in errors. Within the relationship between sites, CRAs, and DMs, we can quickly correct misunderstandings of eCRF completion guidelines (CCGs), even revising CCGs for clarity. Without unmasking specific points of data, the sponsor can be part of decisions to improve the quality of the data. These steps to correct some manageable problems can allow the CRA the needed time to address more complex issues at on-site visits. Early intervention mitigates the risk of unusable data at the end of the trial.
When the EDC is integrated with the CTMS module, clinical trial managers (CTMs) and project managers (PMs) have immediate and continual real-time insight into project metrics. Data such as trial enrollment numbers, participant status, and source data verification activities are automatically imported from the EDC into the CTMS and are available on a CTMS dashboard or can be inserted into a site visit report. Sponsors are also given real-time access to these meta-data. This transparency opens a two-way communication between PROMETRIKA’s trial team and the sponsor, leading to quicker resolution of administrative problems. Early resolution of a site problem, or recognition that a site needs to be replaced, saves precious time and money in the conduct of a trial.
Trial documentation, in the form of an eTMF, is a major compliance activity during a trial. Integration of the CTMS and eTMF, which will be available this summer, will reduce manual efforts for a number of documents. For example, once a site visit confirmation letter, follow-up letter, or visit report is finalized within the CTMS, the document will be auto-filed in the eTMF. This will ensure that the eTMF is contemporaneous and complete, an extremely useful feature in trials with a large number of sites!
PROMETRIKA continually works to improve transparency of trial processes and communication with sponsors. Through integrated clinical trial tools, PROMETRIKA can share trial management data with sponsors and third-party vendors in real time, paving the way for open communication, timely process adjustments, and enhanced trust throughout the trial team.
