Client number for monitoring: 33

By Phase
Clinical Trial Phase I 2 Clinical Trial Phase II 20 Clinical Trial Phase III 60
Post-Marketing Surveillance 15 Others (clinical pharmacological studies, etc.) 7
Total 104
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By Therapeutic area
CNS medicines *1 19 Oncology medicines/immunosuppressants *2 5 External application *3 3
Sensory organs *4 3 Infections *5 6 Cardiovascular *6 10
Gastrointestinal *7 12 Endocrinology/metabolic *8 20 Urological *9 4
Renal *10 8 Cerebrovascular diseases 6 Others (including medical devices) *11 8
Total 104
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Notes:

 

*1 Epilepsy, rheumatoid arthritis, anorexia, cerebrovascular dementia, panic disorder, chronic insomnia, etc.
*2 Malignant neoplasm (e.g. non-small cell lung cancer), rheumatoid arthritis, uterine cervical cancer vaccine
*3 Dermatology/allergies, inflammatory eruption (acne), nail tinea
*4 Ocular hypertension, glaucoma, etc.
*5 Infection, pediatrics/infection, internal medicine/infectious diseases (RTI), sinusitis
*6 Hypertension, cardiac arrest, hyperlipemia, etc.
*7 Gastric ulcer, reflux esophagitis, gastritis, constipation, stomal ulcer, gastroduodenitus
*8 Diabetes mellitus, hepatitis C, osteoporosis
*9 Glomerulonephritis, diabetes insipidus
*10 Chronic kidney disease
*11 Peritoneal dialysate, pediatric vaccine, food for specified health use, implant, etc.

 

Companies contracted for GCP data management, statistical analysis: 40

By Therapeutic area
CNS 13 Oncology medicines/immunosuppressants 6 External application 3
Sensory organs 3 Infections 12 Cardiovascular 17
Gastrointestinal 11 Endocrinology/metabolic 17 Urological 5
Respiratory 6 Hormones 11 Others (including infusions and medical devices) 19
Total 123
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Phase specific by segment
Phase I Enrollment 0 Data management 11 Statistical analysis 11 CSR writing 3 25
Phase II Enrollment 1 Data management 41 Statistical analysis 14 CSR writing 5 34
Phase III Enrollment 4 Data management 38 Statistical analysis 55 CSR writing 14 111
Phase IV Enrollment 1 Data management 4 Statistical analysis 4 CSR writing 1 10
Others
Epidemiological
studies		 Enrollment 0 Data management 3 Statistical analysis 3 CSR writing 0 6
Total 213
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Client number for PMS data management, statistical analysis: 24

By Therapeutic area
Cardiovascular 43 Other metabolic 14 CNS 16
Diabetes 19 Oncology 23 Immunosuppressants 9
Antibiotics 15 Urological 7 Gastrointestinal 9
Hormones 12 Respiratory 5 Allergies 5
Peripheral nerve 4 Others 66
Total 247
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By patient volume
>10,000 patients 25 6,000 – < 10,000 patients 16 3,000 – < 6,000 patients 58
1,000 – < 3,000 patients 33 < 1,000 patients 72
Total 204
※Excluding 100% surveys
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