AE-Connect 5.8 (Adverse Event/Side Effect Reporting Form Collection Management)
MR Adverse Effect Reporting Collection and Management System (Safety Information Collection)
Electronically collect side effects and adverse events (safety information) using mobile devices to improve the situation of MR!
AC-Connect: A new standard for collecting adverse event information that balances accuracy and speed, making adverse event reporting smarter. 'AE-Connect' is a system that allows medical representatives (MRs) to quickly and reliably report safety information obtained to the pharmacovigilance (PV) department using a smartphone. When an MR obtains information about an adverse event at a facility, they can input the necessary information for the initial report through the web browser on their mobile device. The initial report from the MR is immediately displayed in a list on the management screen of the safety management department (PV department), where detailed information can be confirmed. Additionally, inquiries to the MR can be made as needed. Furthermore, new information can be added as supplementary information to previously reported data. 【Features】 ■ Streamlines the time of busy MRs ■ Maintains the accuracy of reported information, allowing the PV department to receive it in a normalized and structured state through input validation features ■ Achieves data linkage with other systems using an industry-standard (E2B) interface (XML linkage) ■ Retains activity records between MRs and PV, as well as audit trails of collected data, ensuring compliance with regulations ■ Allows files to be attached to contact report information, enabling centralized management of information related to the contact report *Please feel free to contact us.
Inquire About This Product
basic information
**Convenience** - There is no need to always carry a computer or adverse event reporting form. - Adverse event information can be registered with operations similar to regular mobile emails, so no special training is required. - Inquiries and responses regarding the reporting content are also possible (general electronic file attachments are allowed). - Additional information can be entered on a PC terminal after returning to the office for detailed information. - Devices equipped with camera functions can attach photos or PDFs to the adverse event reporting form. - There are no restrictions on where to report (while walking, on the train, from home, during meals, etc.). This system is a configurable system that can be set up according to your business requirements. Requirements will be organized during the requirements definition phase (configuration phase), implemented, verified, and then put into operation. *For more details, please download the PDF or feel free to contact us.*
Price information
The number of registered users and the number of reporting destinations (affiliated parties) may vary, so please feel free to contact us.
Delivery Time
Applications/Examples of results
For more details, please download the PDF or feel free to contact us.
Detailed information
-
- AE-Connect is a safety information collection application compatible with smartphones such as iPhone/iPad, enabling medical representatives (MRs) to report quickly and accurately to the headquarters' Pharmacovigilance (PV) department from the field, thereby supporting the efficiency of tasks related to adverse event reporting. - All communication records with MRs regarding adverse event notification forms and investigations are managed within AE-Connect. - You can manage registration and inquiry statuses. - The collected safety information is integrated with safety databases such as Argus, Pargiv, Clinical Works, and LS (ARIS).
-
Example screen for AE-Connect adverse event report input 1. [Login] Authenticate with the registered MR's user ID and password to allow login, displaying the menu for each MR. (SSO compatible: method to be discussed) 2. [Adverse Event Report Input Screen] Input the newly obtained adverse event report. 3. [Adverse Event Report List Screen] Set search conditions to display a list of adverse reports that meet the criteria. You can check the details of the selected adverse event report from the list. 4. [Inquiry Response Input] Confirm inquiries from the safety management department and input responses.
-
Example screen for AE-Connect adverse event report input (2) Selection input (Master reference) Basic information such as company pharmaceuticals, medical facilities, responsible physicians, and event names is managed in a master database and can be selected for input. This reduces minor input errors such as typos and incorrect conversions. The master database is regularly updated in coordination with the internal system to maintain the latest status.
-
Example screen for AE-Connect adverse event report input (3-1) input check Logical checks during input reduce the registration of inconsistent information. Logical checks can be set for each information acquisition route. - Required input fields, character count checks, prohibited character checks - Date inconsistencies - Information inconsistencies (e.g., severe but severity assessment criteria not selected)
-
Example screen for AE-Connect adverse event report input (3-2) input check After pressing the data registration button, a logical check is performed, and the error details and locations are displayed at the top of the screen. The error details are visualized and displayed using red, yellow, and blue, similar to a traffic light. Errors that require correction (red) have embedded links, allowing direct navigation to the correction page. - Red: There are items that have been determined to have errors during the input check. Correction required. - Yellow: There are items that have been determined to have warnings during the input check. No correction needed, registration possible. - Blue: There are no errors determined during the input check. Registration possible.
-
Example screen for entering side effect notification forms in AE-Connect (4) Causality Causality input fields are automatically generated based on the number of entered drugs (products) and reported events. Causality is selected from pre-set options. (Responses such as "related," "not related," "cannot be denied," "unconfirmed," etc., are configured in the settings.)
-
Example screen for receiving AE-Connect adverse event report forms (5) Safety information reported by MR is immediately communicated to the safety management department. At the same time, notifications are sent via automatic email to the pre-set reporting destinations. Users in the safety management department can view a list of registered adverse event report forms and their statuses. They can select a report form ID from the list to check the detailed information.
-
Example of the inquiry screen for the AE-Connect adverse event reporting form (6) Select the report ID from the list of adverse event reporting forms, check the detailed content, and if there are any doubts about the reported content, input your inquiry, which will notify the responsible MR. The MR who receives the inquiry will access the inquiry details on AE-Connect via the email link and respond to the inquiry. AE-Connect records and centrally manages all processing statuses of the reporting forms, including interactions between the safety management department and the MR.
-
Image of data linkage between AE-Connect and safety databases (Argus/ARIS/CW/Persive, etc.) The collected adverse event data can be electronically registered into a safety database system with an ICSR interface (e.g., Argus Safety) after confirmation by the safety management department. Adverse event information can be processed individually or in bulk. - An XML file is generated according to the E2B ICSR reporting standards and stored in a specific Out folder for linkage purposes (for safety management systems with ICSR import functionality). - Linkage is completed by importing the ACK file generated according to the E2B ICSR reporting standards from a specific IN folder. - The entire linkage process can also be achieved using EDI tools (subject to consultation).
catalog（1）
Download All Catalogs
Company information
Our company is committed to promoting appropriate IT investments and utilization in businesses by investigating the current situation, including operations, environment, and strategy, and proposing and providing systems that align with the original business, scale, and regulations while suppressing excessive investment in IT. In particular, we focus on the development, sales, and support of software related to the entire process of research and development of pharmaceuticals for the pharmaceutical industry, as well as supporting pharmaceutical development operations and providing consulting for IT implementation, all while offering comprehensive support for systems that comply with the regulations (ministerial ordinances and guidelines) of the Ministry of Health, Labour and Welfare. Please feel free to contact us if you have any inquiries.