ASKLEP
Asklep Inc. been delivering services as a Contract Research Organization (CRO) in Japan since 1992. It is committed to solve their clients’ business issues with their highly integrated marketing research concepts brought by INTAGE and IT functionality that provides real-time business solutions.
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Type | Private |
Founded | 1992 |
Headquarters | 8th fl. World Importmart Bldg., 3-1-3
Higashi-Ikebukuro Toshima-ku, Tokyo 170-8630 Japan |
Key people | Yuichi Yahagi |
Number of employees | 230 |
The company gives top priority to reliability assurance and delivers products that meet specific level of quality when collecting information and preparing documents for all kinds of applications. It strives to improve quality of ervice by thorough compliance with SOPs, saving records and trails, and intensive education and training. They are committed to develop awareness about the data and the value of their products.
History
Jul. 1992 - IBRD Japan Co., Ltd. founded
Apr. 2000 - Marketing Intelligence Corporation acquires IBRD Japan from Kuraya (Marketing Intelligence Corporation changed its name to INTAGE Inc. in April 2001.)
Apr. 2003 - IBRD Japan re-brands as ASKLEP Inc.
Oct. 2004 - Provide EDC solution services for post marketing surveillance studies
Jan. 2008 - Signs a strategic licensing and development agreement with XClinical GmbH (Germany) to bring the GCP EDC compliant system “MARVIN” to the Japanese market
June. 2008 - Signs strategic partnership agreement with global CRO, and launches full operations
Nov. 2010 - Establishes Local Subsidiary, ASKLEP CHINA Inc., in Shanghai, China
Apr. 2012 - Merged with PPCJ Corporation
Jun. 2012 - Establishes Local Subsidiary, ASKLEP TAIWAN Inc., in Taipei , Taiwan
Nov. 2012 - Establishes Local Subsidiary, ASKLEP KOREA Inc., in Seoul , Korea
May. 2013 - RPS Asklep Inc. established
June. 2014 - Spun off clinical development operations and related businesses to A2 Healthcare Corporation, a newly-established, wholly-owned subsidiary of Itochu Corporation. Asklep-owned shares in Asklep and its overseas subsidiaries in China, Taiwan, and Korea as well as RPS Asklep Inc. (JVC) delivered to Itochu Corporation.
May. 2015 - Asklep Enters Capital Tie-up with Kyoto Constella Technologies Co., Ltd.
Oct. 2015 - “ADDIN EX” - A New Version of ADDIN, The Data Collection System for Post-Marketing Surveillance Just Released
Mar. 2016 - Asklep Enters Business Capital Tie-up with Assemblogue, Inc.
Dec. 2016 - Asklep acquires ownership of Kyoto Constella Technologies Co., Ltd.
Services
- Clinical Trials (GCP)
- Post-Marketing Surveillance (GPSP)
- Pharmacovigilance (GVP)
Pharmacovigilance
Service Features
Point 1. Well-organized and well-prepared team of professionals in pharmacovigilance and MD to meet your needs.
Point 2. Proven and trusted brand to implement all projects from registration to evaluation draft preparation tailor-made to your requirements.
Point 3. Ability to provide extensive and comprehensive support of pharmacovigilance from consultation and IT system assistance.
Services Provided for GVP
- Domestic Safety Information Requirements
- Preparation of primary evaluation drafts, Planning reexamination item drafts, and Case entry into database
- Provision of quality check of evaluation content and data entry
- Preparation of CIOMS
- Design of reexamination items, Requests for reexamination and Support for MRs and CRAs
- Preparation of individual case report drafts to PMDA concerning AEs, Infections, and medical devices defects
Note: The above services are provided by Asklep staff on-site at the client office.
- Foreign Safety Information Requirements
- Preparation of primary evaluation drafts on foreign information by CIOMS and Med Watch
- Preparation of individual case report drafts for submission to PMDA on AEs, Infection, medical devices defects
- Additional services
- Consultation on Pharmacovigilance - In-country Clinical Caretakers