The key behind successful clinical trials is transparency and seamless access of data at all levels, assisted by effective, collaborative workflows to mitigate identified risks.
For this reason, Exom developed, a data-driven approach to manage clinical trials. In cooperation with SAS®, Exom developed and utilizes Clinical Trial Intelligence (Genius Wizards™) to monitor and track metrics or key performance indicators (KPIs) in the form of reports or dashboards. The challenge of making meaningful use of these metrics to unearth hidden trends and patterns is done using statistical algorithms, to improve the overall quality of trial operations.
Qualified and senior study managers ensure efficient coordination and reporting of your national or multinational study. We provide complete planning, coordination and control of resources, timelines, communication, costs, and quality as well a detailed risk management plans, through the following activities.
- Professional management of communications and client relationship
- Definition and control of timelines and budgets
- Efficient management and coordination of the study team
- Contribution to the content of key trial documents such as protocol, patient information and informed consent form, case report form
- Development and execution of appropriate project-related plans: communication plan, recruitment plan, quality control plan and risk management plan to guarantee the smoother project conduction and completion
- Management of contractual issues with investigators and hospitals
- Organization of Investigator’s Meetings
- Set-up and maintenance of study specific CTMS
- Management of day-to-day operational aspects in relation to management of Country Study Managers/Site Monitors, organization of trainings and presentations, subjects’ recruitment, tracking of drug supply, data flow and collection, safety reporting, trial supply logistics, preparation of newsletters
- Revision of project plans as appropriate to meet changing needs
- Preparation of weekly/monthly study status reports to the sponsor
- Set-up and maintenance of study eTMF
- Cooperation with RBM manager, data manager, statistician, and Pharmacovigilance Manager
In addition, the use of an eTMF, compared to a traditional paper-based TMF allows for a much more efficient trial management.
of documents were uploaded to the eTMF in accordance with the expected timelines
the median time between the date of document collection and upload to the eTMF
of documents directly uploaded by the investigator