Pharmacovigilance Support Service

CAC Croit’s pharmacovigilance (PV) solutions ensure drug safety to promote the optimal use of your product.

Main Features

  • 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

Achievement

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

Experience

  • 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.
Task Japan Overseas
Literature screening
Book in (Issuing case numbers)
Data entry
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)
MD Review

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
Literature review
Drafting of reports to authorities
Translation (Japanese to English and vice versa)
Data entry
Archiving
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
  • Data entry to Argus J:8 companies
  • DB transfer to Argus:6 companies
  • Consulting services for DB transfer to Argus:3 companies
 Experiences in domestic and international cases include:
  • Drafting of individual case evaluation report
  • Drafting of literature evaluation report
  • Drafting of measure report/research report evaluation
  • Drafting of report to authorities
  • Handling information received from call centers
  • Book In (Issuing case numbers)
  • Data entry
  • MD review
  • Conducting resurvey and additional queries
  • Preparation of CIOMS forms and translation of narratives
  • Reconciliation
  • Archiving
  • Data migration for DB transfer,etc.

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