Services
Achievement
Introduction of past entrusted work of SRD
Since our establishment in 1989, we have provided supports in clinical development of various pharmaceutical products and medical devices. Currently, we provide a wide range of consulting services from the early stages of development to the regulatory submission of application for pharmaceuticals, medical devices, regenerative medicine, and other products.
01. Experiences & Achievements
Clinical Trials (Monitoring) :
By
Therapeutic Areas
The pie chart shows the number of studies by therapeutic areas for which monitoring work was entrusted to SRD. Recently, our business relating to clinical trials in various therapeutic areas, especially for Oncology has been growing. In “Dermatology & Sensory Organ”, “Musculoskeletal” areas, SRD had been appointed as preferred vendor from many clients, and was able to experience many trials.
Jan, 2000 – Mar, 2024 196 Studies
Oncology
41 studies
Derma. & Sensory Organ
35 studies
Musculoskeletal
27 studies
CNS
20 studies
Digestive organ
11 studies
Others*
62 studies
*Genetic, Hematology, Immunology, Endocrine/ Metabolism, Respiratory Organ, Infectious Diseases, Orphan Diseases, etc.
02. Experiences & Achievements
Clinical Trials (Monitoring) :
By
Stage of
Study
The number of studies (by phase) that have been entrusted to SRD are described below (including sponsor-initiated and investigator-initiated clinical trials). SRD has also experienced for, in addition to monitoring, DM/statistical analysis, auditing, and clinical trial coordination secretariat services for investigator-initiated clinical trials, which have been increasing in recent years.
Jan, 2000 – Mar, 2024 196 Studies
PI
30 Studies
PII (Including PI/ II)
66 Studies
PIII (Including PII/ III)）
66 Studies
PIV
12 Studies
Medical Devices
18 Studies
Others*
4 Studies
*Clinical Pharmacology Studies, OTC, etc.
03. Experience & AchievementsRegulatory Affairs
Summary of the experiences and achievements of our regulatory services shown below. SRD can provide supports for various regulatory application documents and to develop regulatory strategies. We provide flexible and detailed support to meet the needs of our clients.
| Services | Projects |
|---|---|
| Supports for Manufacturing and Marketing Approval Application (Medical Device) |
More than 50 |
| Supports for Manufacturing and Marketing Certification Application (Medical Device) |
More than 60 |
| Supports for Manufacturing and Marketing Approval Application (Medical Drug) |
More than 10 |
| In country caretaker (ICC)/registration of Drug Master Files (DMF) | More than 50 |
| In country agent/application for Accreditation of Foreign Manufacturers (AFM) | More than 50 |
| PMDA consultation | More than 20 |
