EPS Clinical Trials Manager
For management, control and governance of Clinical Trials.
This user-friendly database application provides both patient-level and trial-based recording and analysis.
The system is available as a stand-alone package or for use in a multi departmental environment. Multiple satellite applications can be distributed, dealing with the management of trial patients and their associated follow-ups. The satellites can then provide monthly reporting of, say, patient numbers and events to a central consolidation database. In this manner, control and audit of trials operating throughout a multi-departmental environment can be maintained.
Product highlights and screenshots
Trial Summary
Provides a snapshot of the current trial and patient status.
Patient numbers are presented for the various user-defined statuses together with category totals for trial exit and death.
Arm/Randomisation analysis is available and patient exits are analysed by reason.
Trial Detail
Information about the trial, sponsors, monitors, contacts and important documents is recorded here, together with hyperlinks to websites and source material.
Approval dates and references are entered here, along with details of the involvement of other trusts/organisations and departments.
The treatment and follow-up templates can be established for the various trial arms/randomisations that are later applied to the patients as they progress through the trial.
List and Manage Patients
Patients are assigned to trials and then to arms/randomisations as required. The patients can be monitored through multiple randomisations.
The current patient trial status is displayed and indicators highlight deaths or trial exits. Reasons for declining/withdrawing are recorded for later analysis.
A number of audit reports are available to track the patients through the trial and to ensure completeness of recording.
Additional patient details covering summary level clinical information, documents (with dates and versions) and specialist nurse details etc, may be completed as appropriate.
Adverse events, SUSAR's, ICSR etc can be recorded against the patients together with action taken - such as informing sponsors.
Follow-Up Templates
Treatment and follow-up templates can be automatically generated using profiles for each arm/randomisation. Each template can be tailored to requirements including preference days (say, clinics on Thursdays).
Templates may be prepared centrally and distributed to the patient-level satellites if required.
When a patient enters the appropriate phase of a trial then the follow-up templates are automatically assigned and generated to the dates appropriate for the specific patient.
The follow-up can then be tailored to the patient and attendance details monitored if required.
Plans and Analysis
Follow-up plans can be created for, say, the next three months to assess and plan workload. Plans can be for a single trial or for all active trials.
Monthly, Year to Date and Trial Totals of patient numbers and selected key statuses can be prepared at any point.
Audit trial is provided to ensure completeness of recording.
The returns are available for distribution to a central consolidation point if required.
