The main study parameters are the visit schedules (along procedures) and treatment sequences. Study schemes are designed once then applied automatically to newly created patients. Ec1-TrialManager® offers CRAs a summary screen, known as Rapid Data Entry, used to display and update patient and center monitoring data.
Ec1-TrialManager® can handle provisional recruitment, study planning, drug and equipment tracking and stock management.
The Essential Documents feature consolidates and tracks all required study documentation, exceeding mandated requirements in case of audit and guaranteeing the quality of study monitoring.

The Financial Planning Module supports both thorough budget planning, and detailed expenditure tracking.
Budgeting is based on the projected recruitment. Expenditure tracking follows real-time patient-related expenses to reflect precisely the actual progress of the patients through the studies. Non-patient expenses are parameter-defined and can be associated with a payment schedule.
Ec1-TrialManager® provides built-in financial reporting including comparison between real and forecast expenditure and monthly, quarterly, semi-annual, or annual budget estimate.
For each expenditure, a national and/or foreign currency can be chosen.

Numerous standard reports are available at all levels of Ec1-TrialManager® and display the following info:

• Progress of the recruitment by study, country and/or center
• Expense reports by study, country, center and financial protocol
• Customized reports may be developed to meet special requirements

Ec1-TrialManager® also contains a sophisticated Correspondent Database, which is linked directly to the studies and controlled during input. This enables elimination of duplicates, access to a history of study participation, rapid search for correspondents, selection of correspondent groups according to user-defined criteria for mail-merges, management of a list of pre-selected correspondents for a study, and management of CROs.

Ec1-TrialManager® features a dB.SQL® query module that can be used to search for data, allowing for almost endless possibilities of formatting and graphic presentation. The query results can be exported to Ec1-TrialManager® or to any other program (office, database).

Data pertaining to a specific center or study can be extracted from the central database for remote use. Once the data has been entered on site, it updates the central database via modem or network synchronization. The graphic interface of the portable module is identical to that of the central database regarding style of entry and navigation.

This module enables standards forms (SOPs) to be incorporated into the Ec1-TrialManager® package. Reports are generated by merging the data into a text document.

Access rights to options are managed by families of users ("roles"). Access rights to study data are managed by product, country and study. Combination of these options enables Ec1-TrialManager® to be adapted to all types of structures.

Ec1-TrialManager® interfaces with the standard office program MS-ProjectTM and can communicate with many other tools (financial, pharmaceutical logistics, data management, etc.) in using the A.P.I. module (Optional).

Ec1-TrialManager® is compliant with the FDA 21 CFR Part 11 rule for management of electronic records (Password changes, complete audit trail, report archiving).

The alert functionality allows the administrator to schedule any procedures that exist in the Ec1-TrialManager® database. These procedures can create alerts, run import-export jobs, perform data entry validation, or create messages notifying users of next steps when a particular milestone is reached.