servicePharmacovigilance (GVP)

Providing speedy and reliable pharmacovigilance service through our well-established team of highly skilled professionals in GVP operations

Our highly professional staff with extensive experience in GVP provide consultation as well as proposals that best meet the needs of our clients.
Our services ranges from registration, data entry, and QC to translation and preparation of evaluation drafts, and are available both on-site at the client’s office and through our data center.
We also provide services for various safety management information, such as receipt, entry, translation, preparation of draft evaluation (all including QC), and ACK confirmation after reporting to PMDA, depending on the situation such as full or partial.

image scroll 画像がスクロールできます

Service Features

Point 1.: Consignment system by well experienced professionals in pharmacovigilance.
Point 2.: Proven and trusted brand to implement all projects from registration to evaluation draft preparation tailor-made to your requirements.
Point 3.: Ability to provide extensive and comprehensive support of pharmacovigilance from PV consultation and IT system assistance.

Main Services with Details

Domestic safety information service (post-marketing surveillance, clinical trials)

Data entry to patient information safety database from safety management information reception
Prepare primary evaluation (draft), prepare follow-up research items (draft)
Prepare individual case report form (draft) to PMDA ⇒ (adverse drug reactions, infectious diseases, medical device malfunctions)
Prepare CIOMS (including Japanese to English translation)

Foreign country safety information service (post-marketing, clinical trials)

Data entry to patient information safety database from CIOMS & Med Watch (including XML file acquisition) reception provided by global business partners
Prepare primary evaluation (draft)
Prepare individual case report form (draft) to PMDA ⇒ (adverse drug reactions, infectious diseases, medical device malfunctions)

Other

Establishment of known and unknown incidents for each drug
Prepare evaluation (draft) from medical literature screening, prepare report (draft)
Consultation regarding safety information tasks

*On-site (stationed at client company office) and off-site (work from our company office including remote working) services available