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1993 October
- CPC Clinic was established.
Dr. Hiroyuki Fukase is appointed Medical Director.
1993 November
- The first IRB is convened.
- Conducted the first clinical trial, a bioequivalence study.
1994
- Conducted first Phase I clinical trial with aged subjects.
- Conducted first Phase I clinical trial with female subjects.
- Conducted clinical trial on Factor XIII (the first administration worldwide).
1995
- Conducted Phase I clinical trial on pre-general anesthetic compound.
- Conducted PK study involving urinary tract contrast imaging.
- Conducted Phase I clinical trial on local anesthetic compound.
1996-1997
- Tokyo and Osaka branch offices are established to serve as sales offices.
- Clinical Statistics division is established.
- Clinical Control department is established.
1997
- Certified as fully GCP compliant following GCP inspections by the Organization
for Pharmaceutical Safety and Research (OPSR). (1st GCP evaluation)
1999-2000
- Conducted the first ever, one site comparative PK study by recruiting Caucasian subjects in Japan.
2001 June 4
- IRB convenes for the 100th meeting. (122 protocols, 74 different compounds
and 119 clinical trials)
2001
- Certified as fully GCP compliant following GCP inspections by the Organization
for Pharmaceutical Safety and Research (OPSR). (2nd GCP evaluation)
2002 October
- Official clinic name is changed to Medical Corporation Kouryokai CPC Clinic.
2002
- Certified as fully GCP compliant following 2 GCP inspections by the Organization for Pharmaceutical Safety and Research (OPSR). (3rd and 4th GCP evaluation)
2002 December
- The Data Management department was renamed the Data Processing department
and the Quality Control group was expanded.
- On-line data management system (LIMS) was established.
2003
- CPC Clinic extended to increase ward area for PD evaluation studies.
- Extra meeting rooms are created for sponsors to conduct monitoring activities
and SDV.
- Certified as fully GCP compliant following GCP inspections by the Organization
for Pharmaceutical Safety and Research (OPSR). (5th GCP evaluation)
2004
- Clinical Laboratory department received ISO 15189 certification from TÜV SÜD Japan.
2005
- Certified as fully GCP compliant following GCP inspections by the Organization
for Pharmaceutical Safety and Research (OPSR). (6th GCP evaluation)
2006
- Kawasaki Management office is established.
2007
- Clinical Laboratory department received ISO 15189 certification from the
Japan Accreditation Board for Conformity Assessment (JAB).
2008 March
- Completed annual ISO15189 accreditation surveillance.
2008 May 12
- IRB convenes for the 200th meeting.
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