After promulgation of the reforms of Japanese Pharmaceutical Affairs Law in 2002, a pharmacovigilance regulation (GVP Ministerial Ordinance) has been in effect since April 2005. Tripartite harmonization, EU/US/Japan, in CIOMS and ICH-WG for management on adverse event/adverse drug reaction information (ICH-E2D) has been completed. In September 2005, ICH-E2E was promulgated in EU/US and also enforced in Japan as a guideline focusing on risk management through development phase to post-marketing pharmaceutical products.
As to safety information on pharmaceutical products, uniformed management through development phase to post-marketing is desired. In accordance with development of globalization in the pharmaceutical field, such as international collaboration in clinical trials, international pharmacovigilance management has become essential (CIOMS VII and ICH-E2F). Taking this trend into account, pharmaceutical companies are required to expand and to reinforce their pharmacovigilance capabilities.
ASKLEP, especially in the PMS arena, has established substantial achievement and become a genuine drug development partner for pharmaceutical companies by providing full package services from patient enrollment to data management/biostatistics.
In April, 2008, ASKLEP launched the Safety Information Department ensuring pharmacovigilance to further complete our services.
In addition to our original PMS services, we have expanded our scope to draft safety information report form, including preliminary evaluation on adverse event/adverse drug reaction (preparing and providing a SGML file) and others.
By providing high quality safety support (data input, preliminary evaluation on safety information, quality control of inputted data), ASKLEP’ s quality work allows our clients to focus on their core businesses.
- Preliminary evaluation on domestic safety control information (AE/ADR and others)
- Japanese translation and preliminary evaluation on CIOMS, MedWatch and other related forms from overseas
- Drafting ADR/infection report, study report and safety measures report, and prepare/provide SGML file
- Quality control on safety control information (ICSR) data entered (in compliance with ICH-E2B/M)
- Transfer domestic AE/ADR information in a spontaneous report to CIOMS format (English translation)
- Preliminary evaluation on foreign literatures, abstracts and proceedings from scientific conferences and study reports (written in English)
- Translation (Japanese ⇔ English) of safety control information
- Consultation on pharmacovigilance
