CAC EXICARE Corporation (CAC EXICARE) provides a one-stop clinical research service with excellent IT capability for overall pharmaceutical development life cycle from clinical trial to post-marketing.
The core values of CAC EXICRE's service are:
IT enabled service from clinical development to PMS
- a long experience to provide custom software development, as well as home- own packaged software such as EDC for both clinical development and post-marketing phase
- a vast experience to integrate and provide operation support using industry-leading packaged software
Wide range of service from business consultation to BPO service
- Pharmacovigilance Center, a shared service center which provides best practice pharmacovigilance operation service ranging from case reception to report preparation for regulatory submission
- Pool of industry-leading subject matter experts to provide service based on best practice
- Offshore capability in collaboration with subsidiaries in India and China.
CAC EXICARE, a 100% subsidiary of CAC Corporation, is a split-off of the pharmaceutical R&D BPO business unit of CAC Corporation.
CAC EXICARE's wide range of services includes:
· Tutorial Service
CAC EXICARE provides a tutorial service on Japanese pharmaceutical rules and regulations lectured by drug safety and pharmacovigilance experts on demand.
· Consulting Service and Safety Database Implementation Services
Consulting services for searching, understanding and evaluating global safety databases under the new regulatory environment in Japan is provided in response to client request. Intensive E2B consulting service covers the so-called Green Book, a guidance published by Japan Pharmaceutical Manufacturers Association (JPMA).
· Computerized System Validation Service
CAC EXICARE provides a consulting service on how to handle computerized system validation (CSV) and electronic signatures/electronic records (ER/ES). Compliance training service is also provided. CAC EXICARE has extensive experiences in developing and implementing global policies and standards for CSV and ER/ES covering three major regions: the EU, the US and Japan.
· Data Validation and Legacy Data Conversion Services
Starting from validation of the existing database system, legacy data conversion from a client’s old system to a new system is an area in which CAC EXICARE has strong experience over the years. CAC EXICARE carries out such activities through intensive discussions with a client and based on the client’s approval.
· e-Submission Service through CAC EXICARE Gateway
Since EDI and Gateway were built for the MHLW, FDA and EMA, CAC EXICARE has focused on secure e-submission to those authorities. CAC EXICARE is a member of the e-Prompt project sponsored by the FDA and has been certified by the FDA for e-submission. In 2008, CAC EXICARE accomplished the mandatory steps for e-reporting to Eudravigilance via Gateway and allowed clients to exchange safety information with the EMEA.
· Safety Data Entry, MedDRA Coding and Medical Evaluation Services
CAC EXICARE provides safety data entry, MedDRA-J coding and medical evaluation services to pharmaceutical clients, regardless of client locations. These services enable American and European pharmaceutical companies to grasp their comprehensive drug profiles and run their signal detection tools on their own databases.
· Hosted Services and Risk Management Services
A pharmaceutical company can use CAC EXICARE’s hosted secure database as if it were their own and keep signal detection/risk management close at hand.
· External Audit and Global SOP Preparation Services
CAC EXICARE provides an external audit service for pharmacovigilance and supports to establish a pharmacovigilance system which withstands challenges raised by FDA and EMA during inspections. CAC EXICARE supports to prepare global SOPs and maintain pharmacovigilance IT systems which meet global requirements. CAC EXICARE’s accurate knowledge on FDA and EMA’s regulations and IT skills enables clients to comply with global rules and regulations.
Other services available only within Japan include data management, clinical site monitoring, statistical analysis, new drug application to Japan's regulatory agency (PMDA), safety data management and system operation services.
For more information, please contact: firstname.lastname@example.org