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.

Experiences & Achievements Clinical Trials (Monitoring) : By Therapeutic Areas

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.

Experiences & Achievements Clinical Trials (Monitoring) : By Stage of Study

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
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