TrialMaster Ph. I System Benefits :

1. Improved productivity
2. Improved responsiveness
3. Improved data accuracy
4. Reduced end to end study time line

None of these benefits are automatically accrued just by the use of the TrialMaster Ph. I system. The benefits are realized only if the opportunity is made to update the clinical trials processes.

A key benefit of the TrialMaster Ph. I system is to use it as a catalyst for change.

Details:

1. Improved productivity
• Monitors have access to the data in real time from any location via the internet.
• All data entered into the system has been checked by the system "Edit Checks", no gross errors will be included in the data.
• Any data that is outside the normal range will have been flagged by the system and the study staff will have been asked to validate and explain the data.
• The monitor can/should raise queries very quickly and these can be responded to by study staff rapid using the EDC system.
• Less time should be spent by the monitor on sites.
• The time spent on sites will be more productive as "Routine" queries have been raised and resolved before the visit.
  
  
2. Improved responsiveness
• Data available in close to real time to all sponsor staff.
• Better ability to report on and act on safety data during the trial.
• Better capability to make decisions (i.e. dose escalation) quickly.
• Data Managers can be checking data as the study progresses and working closely with Monitors ensures data integrity at all times.
  
  
3. Improved data accuracy
• Edit checks prevent gross errors.
• Monitors can raise questions quickly, while the study staff are still available and have recollection.
• TrialMaster Ph. I is a catalyst that helps enforce data standards, so "Apples" are compared to "Apples".
  
  
4. Reduced end to end study time line
• Reuse of standard components and enforced data standards will enable studies to be set up with less resource (and less time).
• Decisions during a study can be made on the basis of more accurate up-to-date information. Dose escalation studies can be accelerated.
• Data base lock can be made within hours of last patient out.

These are real benefits. But they cannot be obtained if work practices and processes remain the same. The TrialMaster Ph. I system is an enabler.