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Set-up of external data integration (Lab, IWRS, images).ePRO/eDiary set-up, including validation and documentation.Database set-up including eEdit checks and UAT performed.CRF design reviewed, approved, and signed by CDM, BIS, PM, and customer.We build trust based on communication and transparency. We do this by outlining each stage in detail so that you know where you are and what to expect.
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Part of our role is to make it as straightforward as possible. Getting your product to market is a multi-faceted process.
#Epro ontime trial
How TFS and Trial Online can support your project: Also, it’s fully compliant with industry and regulatory standards. We like it for its ease of use and cost-effectiveness.
#Epro ontime plus
TrialMaster™ Trial Online EDC is used globally in all types of clinical trials (I-IV) and indications, plus it’s suitable for non-interventional studies, as well as for investigator-initiated studies. Role-based security (a standard set of roles which can be modified).Compliant with 21 CFR Part 11 Standards.Hosted solution (data centers & nightly backup).Long-term relationship with OmniComm and the technical support team (EU & US) established before 2000.20 CDMs fully trained on TrialMaster, including 8 people capable of programming the eCRF.30+ active studies ongoing in TrialMaster.Used since 2000 on the global market for phase I-IV studies, NIS and RWE, and investigator-initiated studies.Alerts and Notifications (SAE, the inclusion of patients, etc).Autoencoder (MedDRA, WHO DD, supporting the change of version).Lab ranges management (central lab and local).Interactive real-time reports for tracking and backlog purposes (standard reports and ad-hoc reporting tool).
#Epro ontime manual
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ePRO/eDiary set-up, validation, and documentation.Validation of the electronic tool used during the study by including UAT lead.eCRF design database set-up using our preferred EDC systems, including edit checks programming.Data management essential documentation (Data Management Plan, Data Validation Plan, Data Transfer Specifications, Data Cleaning Plan, etc.).Data Management services Full-service data management support: