No special hardware or software equipment is necessary locally, except for a standard computer equipment and an Internet access. For Investigators, a half a day training in the software is required before the first e-trail, and the following studies follow the same self-explanatory system without further training or Investigator meeting being necessary. A crucial factor for using e-trial’s advantages to a maximum is an optimal internet access (ideal: fast and continuous access).
On-line study document availability and online help at the level of the e-crf make the bulky document management nearly redundant.
System security complies to international regulatory requirements, assuring unique identification of the user and full confidentiality of the data with a full data track.
The advantages of e-trials are:
Improved quality of data. Decreased data queries (by some 80 – 90% because of the data checks at data entry level which are addressed directly and immediately by the Investigator or Study Nurse)
Decreased on-site monitoring (less visits, less time at site, less frequently). The on-site monitoring is reduced to Source Data Verification
Increased transparency in all phases of the study allows for earlier decision-making by empowered study managers
Avoidance of inclusion of patients beyond the number required per protocol
Faster data base lock and less time to market
More uniformity of systems from study to study
Clinical studies using e-data management represent saved time and workload and increased transparency to empowered teams.
Clinical studies using e-data management represent saved time and workload and increased transparency to empowered teams.
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