Pharmacovigilance Support Service
CAC Croit’s pharmacovigilance (PV) solutions ensure drug safety to promote the optimal use of your product.
- Outsourcing appropriate to your safety management conditions
- Flexible services meeting your needs as well as complying with E2B (R3)
- Covers a wide range of products including oncology, cardiovascular, infectious disease, and blood-related drugs
- Ensures safety and high quality services offered by our thoroughly trained staff with PV expertise
- Onsite work at your office location if required
- Case reviews by medical doctors (MD) with various experiences and skills
- Maintains consistent quality by establishing a quality management system
Proportion of total CRO PV Sales occupied by CAC Croit
We account for more than one-third of CRO PV sales in Japan.
Source: Japan CRO Association, ‘2016 Medical Products/Devices/Food & Nutrition-Supplement Sales by GVP (PV) services’ in Annual Report 2016
- We have handled both domestic and international cases.
- We have supported data entry and evaluation of cases of numerous sizes. We process approximately 350,000 cases annually, and are acknowledged as being top of the class in Japan.
|Book in (Issuing case numbers)||✔||✔|
|Drafting of evaluation reports||✔||✔|
|Drafting of reports to authorities||✔||✔|
|Resurvey and additional queries||✔||‐|
|Drafting of CIOMS forms||✔||‐|
|Translation of narrative into Japanese||‐||✔|
|Archiving (onsite only)||✔||✔|
Reviews by MDs with various experiences and skills
|No. of MDs||15 (as of November 2017)|
|Experiences||6 companies in Japan|
|Services available||Medical evaluation for adverse events of investigational and over-the-counter products
- Seriousness, causality, predictability
- MedDRA coding
Selection of queries that require medical evaluation
Drafting of reports to authorities
Translation (Japanese to English and vice versa)
|Our activities||Education and training for project members
Response to case evaluation questions
We are one of the top companies in Japan with experience in Argus tasks.
Past and present experiences in Argus J and the operations contracted:
|Experiences in Argus|
|Experiences in domestic and international cases include:|