ES1-SafetyManager® is a software tool for management and declaration of ICSRs (Individual Case Safety Reports) whatever their origin (spontaneous notification, clinical trial, literature or Authorities). It can be configured using a vast parameter set to adapt the program to the needs of local and international departments.
Its user-friendly graphic interface makes it very easy to use.
ES1-SafetyManager® is designed to comply with international recommendations (ICH, EMEA, FDA) that are indispensable for declaring ICSRs.

All modifications are tracked (according to 21 CFR Part 11 on electronic records)

Each case is identified by a parameter-defined number whose uniqueness is controlled. A case can contain several reporters, drugs (suspect and associated treatments) and adverse reactions.
Cases can be conveniently coded using standard dictionaries (MedDRA,WHODRUG,…) or specific dictionaries.

An existing case can be:
· updated (while keeping a trace of its modifications: notion of case versions),
· entered using the terminology of the country,
· validated, closed, or locked.

ES1-SafetyManager® automatically handles reminders sent to reporters until cases in the process of documentation are complete.
Case printouts can be customized by choosing the sections to be included.

In compliance with the regulations, the declaration of a case (or of a group of cases selected according to several criteria, for example "all serious cases input in the last week") can be printed in an official format (CIOMS, MedWatch, CERFA).
Specific printouts could be also integrated into ES1-SafetyManager®.
Ability to use PDF format for electronic mail.

In compliance with the regulation, ES1-SafetyManager® prints:
· The Line Listing with numerous configuration and case selection possibilities,
· The Summary Tabulation, and the Addendum, if necessary.

The dB.SQL® query module enables users to interrogate every field of the database. The result of consultations can be formatted, printed and exported to other programs (Word, Excel..) or saved in a query library.

The Case Distribution module of ES1-SafetyManager®, which is totally configurable, is used to send a selection of cases (by mail or fax) in specific formats (CIOMS, MedWatch, etc.) to a list of recipients meeting one or more criteria. The dispatch delay is parameter-defined by case type (serious, unknown, etc.).

The Workflow module is used to monitor a sequence of activities in order to control the sharing of tasks and execution delays. It responds to questions such as "Who does what?", "When?"
It is an appreciable aid since, when ES1-SafetyManager® opens, the user can immediately see, case by case, the task to be completed and the deadlines. Once a task is completed, it is validated, after which the case or work document is automatically passed to the person in charge of the next task.
Cases can be accessed directly from the Dashboard

The Electronic Transmission module complies with international regulations (FDA, EMEA). It will be able to generate XML/SGML messages ready to be sent and receive ICSRs. It includes complete tracking of Import/Export actions offering the ability to query and report all actions.

ES1-SafetyManager® is compliant with the FDA Title 21 Code of Federal Regulations Part 11 rule for management of electronic records by controlling password changes, providing complete audit trail and allowing report archiving.

Fields (mandatory, not used), Reorganization of Menu (and succession of screens), Additional Customized Screens (Check-Lists), Case Consistency, Alerts (and messages).

In mixing standard screens and customized options, the ES1-SafetyManager® implementation time is reduced, allowing you to save time and money.