GVP Contract Service｜Safety Information Services｜General Incorporated Foundation International Medical Information Center (IMIC)

Our extensive experience ensures cost-effective solutions for your needs.

Are you struggling with time-consuming record-keeping, manpower costs, storage space, or other related expenses?
IMIC can drastically reduce your company’s workload by organizing and delivering the information to you.

As part of the "collection of safety management information" stipulated in the Ministry of Health, Labour and Welfare Ordinance No. 135 (September 22, 2004), the "Ordinance on Standards for Post-Marketing Safety Management of Pharmaceuticals, Quasi-Drugs, Cosmetics, and Medical Devices" (GVP Ordinance),
we will collect and organize information regarding reports from academic conferences, scientific literature, and other research.
By alleviating the administrative burden of screening large volumes of literature and organizing the data, you can redirect your resources toward core tasks such as safety evaluations.

In addition, we possess a wealth of experience spanning from initial capability verification prior to commencement, to subsequent internal and global audits, and even support during regulatory inspections. We are fully committed to providing comprehensive support for your operational audits.

ABOUT

Overview of GVP Contract Service

Reliable GVP Contract Services by Specialists in Medical Literature

This is IMIC's specialized safety assurance contracted service, designed to comply with the Good Vigilance Practice (GVP) standards for post-marketing surveillance of pharmaceuticals. As part of the "collection of safety management information" stipulated in the Ministry of Health, Labour and Welfare Ordinance No. 135, commonly known as the GVP Ordinance, we collect and organize information regarding reports from academic conferences, scientific literature, and other research.

We offer full support from information collection.

We provide a comprehensive support system from the collection of literature information to final delivery. IMIC handles information collection for both pharmaceutical products and medical devices.

For pharmaceuticals and other products: “SELIMIC-Alert” is used to collect domestic literature on adverse drug reactions, while medical and pharmaceutical databases are used for overseas information as part of the “Overseas Drug Safety Information” service.
For medical devices: “DEVICE SAFETY BASE” is used to collect information from both domestic and international sources.
For biological materials: We offer an “Infectious Disease Report on Biological Materials” service.
For information on overseas measures: We offer a “Rapid Reporting Service for Overseas Measures Information.”

You can minimize revisions to your SOPs.

You can have your data and literature reviewed without changing your current information-collection methods.
By sending us the data and literature your company currently collects, you can start using our services at the filtering stage of your database search results. This allows you to transition smoothly to our contracted services without changing your existing information sources.

We can customize our services to fit your budget.

We can tailor our services to fit your budget. You can choose to outsource only your core products to us, and we will propose the optimal solution based on your budget, including the filtering criteria for database search results and the information to be included in reports.

Flow for GVP Contract Service

1 Database search (SDI search)

We search domestic and international databases.
We formulate search queries and set up alerts (MEDLINE, EMBASE, etc.).
2 Obtaining search results and creating a literature management table

We receive alert data and manage the bibliographic information database.
3 Filtering of database search results

Based on the selection criteria, we remove unnecessary data from the abstracts, titles, and keywords of the search results, and proceed to obtain the necessary literature.
We then deliver a list of accepted and excluded search results and commented-on lists.
4 Literature retrieval and copying

We will request and obtain any necessary literature from our own collection and our partner libraries in Japan.
5 Literature review

We review the full-text literature and determine whether it needs to be reported to the client based on the selection criteria.
6 Report preparation
- Basic information (bibliographic information, target ingredient name, adverse event term)
- Additional information (number of ICSRs, content of research reports, etc.)
7 Delivery of reports and original literature
- Report form: Electronic media (CSV / Excel / Word)
- Original literature