Rapid database deployment
Clinical trial research is a fast-paced industry whereby the requirement to bring lifesaving and life changing drugs to market quickly, to meet patients needs, is a constant driver to looking for time saving innovations. As a result, pharmaceutical companies are frequently looking for ways to expedite clinical trial set up and execution while maintaining regulatory compliance and data quality.
At PHASTAR, we provide tailor made EDC solutions for our clients that will allow rapid set up and deployment, partnering with our EDC partners Medrio and Medidata to achieve this. During the contracting phase of a new study, importance is placed on actively engaging our partners and clients in exploring solutions for data capture that will ensure efficient database set-up, short timelines and quality data collection. For example, innovative and flexible forms to support long-term observational studies where data collection may vary between subjects depending on the local healthcare provider, ensuring flexibility while maintaining quality.
It is important to advise clients of the structures and methods available for efficient set up – we would strongly recommend to our clients the use of standard CDASH structures to build the EDC platforms for data collection. This allows our database programmers to pull forms and edit checks from our extensive library of standards, saving time and building in efficiencies across programs of studies with no compromise on quality. Working in close collaboration with both of our EDC partners allows support of short timelines in the set-up of instances in line with trial timelines and contract completion. This not only supports effective database set up and a reduction in timelines, but further supports the production of standard SDTMs and ADaMs and thus also efficiencies in reporting timelines.
Both EDC platforms, Medrio and Medidata, allow for whole studies to be duplicated. Utilising these two platforms gives clients access to time, resource and potentially cost savings across the set-up of multiple studies in drug development programs, all while further benefiting site and user experience as they gain familiarity in the data collection tool.
All data management set-up processes are supported by a robust suite of SOPs, containing multiple templated documents to support the specification of the EDC system as well as agreements on executions activities, for example discrepancy management, dictionary coding of medical terms and SAE reconciliation. This allows for rapid completion by our experienced team of data managers during the set-up phase and all templates have been developed to ensure ease of review by clients resulting in short review and approval timelines.
The use of standards has allowed PHASTAR to support clients in achieving timelines in set-up which would have traditionally been months to a matter of weeks. Set-up timelines of less than six weeks from contract completion to site deployment is achieved across the board, from Phase I PK studies through to long-term registry data collections.
As the recent COVID-19 pandemic has illustrated, the need for fast paced clinical trial research to bring new medicines and vaccines to market is imperative, now and in the future. At PHASTAR, we are dedicated to working closely with Medidata and Medrio to bring down setup timelines and ensure we can support our clients in rapid database deployment through sharing of best practices, expertise, innovations and ideas.