Experiences of eCompliance
Experiences
We have lots of know-how by abundant experiences of Global Safety Information Management System Implementation Support.
| Company name | Support contents | System name | Remarks |
|---|---|---|---|
| Company F | Global Safety Information Management System Implementation and CSV performance support | Argus Safety | |
| Company S | Global Safety Information Management System Implementation and CSV performance support | ARISg | |
| Company M |
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ARISg/j Perceive/AE |
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| Company B | Package Assessment support of Safety Information Management System Implementation | Oracle/AERS vs Perceive/AE | Support to implementation |
| Company A | Safety Information Management System Implementation and CSV performance support | Argus Safety & Perceive/AE | |
| Company B | Safety Information Management System CSV performance support | NeWays & Perceive/AE | |
| Company D | Local Safety Information Management System Retrospective CSV performance support | CW4/ADR | |
| Company S | Local Safety Information Management System Implementation and CSV performance support | Perceive/AE | |
| Company B | Local Safety Information Management System Retrospective CSV performance support | Perceive/AE | |
| Company D | Local Safety Information Management System Retrospective CSV performance support | Perceive/AE | Support to implementation |
| Company B | Local Safety Information Management System Retrospective CSV performance support, Local Medical Device Safety Information Management System Implementation CSV performance support | Perceive/AE Perceive/MD |
SOP Consultation Experiences
EC support CSV consultation and creating policy, guideline and SOP corresponding to Japanese ER/ES guideline etc..
CSV SOP consultation results
- SEP.2002-JAN.2003 Foreign affiliated major pharmaceutical company A
- JAN.2004-JUN.2004 Foreign affiliated major pharmaceutical company B
- OCT.2004-OCT.2005 Domestic major pharmaceutical company A
- MAY 2004-DEC.2004 Domestic major pharmaceutical company B
- APR.2005-SEP.2005 Domestic major medical device company A
- DEC 2007-MAR 2008 Domestic major food company J
21 CFR Part 11 SOP consultation results
- AUG.2004-MAR.2005 Domestic major pharmaceutical company A
- JUL.2004-DEC.2004 Domestic major CRO company M
- FEB.2005-MAR.2005 Domestic major medical device company A
- NOV 2006-MAR 2007 Domestic major medical device company M
SOP consultation corresponding to Japanese ER/ES guideline results
- AUG.2005-SEP.2005 Domestic major pharmaceutical company D
- APR.2005-SEP.2005 Domestic major medical device company A
- JAN.2006-MAR.2006 Domestic major pharmaceutical company S
- JAN.2006-MAR.2006 Domestic major CRO company C
- JAN.2006-MAR.2006 Domestic pharmaceutical company S
- MAR 2007-AUG 2007 Foreign affiliated major company L
- APR 2007-DEC 2007 Domestic medium sized CRO J
Other SOP consultation results
- JAN.2005-MAR.2005 Foreign affiliated major medical device company B (GVP,GPSP)
- NOV.2004-DEC.2004 Foreign affiliated major pharmaceutical company C (GPMSP)
CSV Performance Support Experiences
| Duration | Company name | System name | Service contents |
|---|---|---|---|
| SEP.2004-APR.2005 | American major bio company | ClinicalWorks4/GCP, Perceive/AE |
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| APR.2003-MAR.2006 | Domestic CRO company | Measurement device overall (HPLC etc.) |
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| OCT.2003-DEC.2005 | Domestic major pharmaceutical company (Tokyo) | LiveLink DD Works |
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| AUG.2004- | Domestic major pharmaceutical company (Osaka) | ClinicaWorks4/GCP, ARISg |
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CSV Performance Support Results
| FEB.2004-DEC.2005 | Domestic major pharmaceutical company (Osaka) | Perceive/AE |
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| MAY 2005-AUG.2005 | Domestic pharmaceutical company (Tokyo) | Perceive/AE |
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| OCT.2005- | Domestic pharmaceutical company (Osaka) | Perceive/AE |
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| DEC.2005- | American medical device manufacturer (Tokyo) | Perceive/AE Perceive/MD |
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| FEB.2006- | Domestic pharmaceutical venture company (Tokyo) | Perceive/AE |
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