LT-Connect 5.8 (Literature Information Monitoring and Evaluation)

basic information

**Features** - It allows for the bulk import of electronic data (CSV format) from SDI services such as JAPIC, WIMDIS, and IMIC. You can set the import information fields for each SDI service. - Not only bibliographic information but also original literature (in PDF format, etc.) can be managed with LT-C. Individual case information is managed in conjunction with AE-Connect. - If reporting to authorities is required based on the collected information, it can be managed in conjunction with a safety information database that supports industry standard formats (E2B compliant) for bulk import. - When evaluating literature information, processing flows can be set according to roles such as verification and approval. Each responsible person can smoothly carry out tasks according to their roles. - It can manage the activity status of literature research monitoring. - It imports obtained literature, conference information, and originals (PDF) for centralized management along with activity records. - It retains activity records of literature and conference information collection, investigation, and evaluation, as well as audit trails of registered information to ensure compliance with laws and regulations. - It can be implemented with validation support. (Validation services are available.)

Price range

Delivery Time

Applications/Examples of results

It is being used by a major pharmaceutical company. *For more details, please download the PDF or feel free to contact us.*

Detailed information

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  Literature information obtained from SDI service companies is screened (primary evaluation, etc.), and if additional information is needed for secondary evaluation or if detailed investigation is required, this function is used to request an investigation from the MR. The MR can receive requests and respond with investigation results using devices such as smartphones or iPads. The PV department collects investigation results in a timely manner and determines the necessity of research reports (secondary evaluation, etc.). Additionally, if there are events that should be processed as individual reports based on literature information or detailed investigation results, they will be processed as individual reports of adverse events in conjunction with AE-Connect. This function retains all records of the literature information obtained, screening and evaluation results, and MR activities related to literature information investigations, and it can share information with safety information management systems (such as Argus, ARIS, Persiv, etc.) for information that needs to be reported to regulatory authorities.

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  LT-Connect: Literature Information Import Screen It allows for the bulk import of electronic data (in CSV format) from SDI services such as JAPIC, WIMDIS, and IMIC. The format and order of the import files can be defined and registered for each SDI service. Additionally, bibliographic information and PDF files of literature copies obtained simultaneously can also be saved in association with the literature information.

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  LT-Connect: Literature Information Screening Screen (Primary Evaluation) When importing electronic data (CSV format) from SDI services such as JAPIC, WIMDIS, and IMIC, the results will be displayed in the import results list.

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  LT-Connect: Literature Information Screening Screen (Primary Evaluation) Select the literature number displayed in the import results list to check the detailed information. After reviewing the detailed information, make a judgment on the need for evaluation; if evaluation is necessary, assign an evaluator, etc. Related PDFs can also be referenced.

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  LT-Connect: Literature Information Screening (Primary Evaluation) Inquiry Screen If there are any inquiries or confirmation items based on the literature information obtained during the primary evaluation, you can contact the medical facility's MR through this screen. The status of the inquiry responses can be checked on a separate management screen.

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  LT-Connect: Literature Information Evaluation Screen (Evaluation In Progress List) Literature information that requires evaluation in the primary assessment and is assigned to the evaluator will be displayed on the evaluator's evaluation in progress list screen.

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  LT-Connect: Literature Information Evaluation Screen The evaluator selects and evaluates the assigned literature information individually and inputs the results. The evaluation items displayed are those that were pre-defined in the requirements specification. If patients can be identified from the literature information (in the case of case reports), basic patient information can be registered, and an investigation request can be made to the MR in conjunction with AE-Connect.

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  LT-Connect: Approval Screen for Literature Information Evaluation Results Once the registration of the literature information evaluation results is complete, it will be displayed on the literature information evaluation approval list screen. The person responsible for the literature evaluation can select from the list to approve individual literature or approve them in bulk. If there are any doubts about the evaluation results, it is also possible to reject (return) them for re-evaluation.