Company Profile

The environment for the pharmaceutical activities changed remarkably and very rapidly during recent five years. This change is based on the global requirement to supply more safer and effective drugs to the patients in timely and to develop with reliable process supported by scientific data.

Actual implementation as a new GCP rules in Japan based on the results of discussion at ICH was started in 1997. However, the progress of re-engineering in Japan to comply with the rules based upon global agreement seems to relatively slow compared with US and Europe.

Global Pharma System Inc. (GPS) provides efficient consulting services and business supports on key activities in R&D and PMS areas for improvement or keeping continuous business quality. GPS also provides series of computer application system which was developed by our own concept and technologies. We developed these systems based on our philosophy that a practical system must be a tool with professional and realistic environment in actual business.

  • Project Management
  • Data Credibility
  • Document Management
  • Auditable Quality
  • System Reliability

GPS will propose the best way for drug development complying with global rules, scientific, and ethical considerations through the careful consultation and analysis of current environment (infrastructure, decision system, and standard operation procedures).
We would like you to consider us when you need for professional assistance. Confidentiality is guaranteed.

  • R&D Management
  • Information Technology
  • Regulatory Affairs
  • Professional Business Services

Company NameGlobal Pharma System Inc.
EstablishedJuly 11, 1997
PresidentTadaoki Suda, Ph.D
CapitalJPY20,000,000.
OfficeAIOS Gatanda Building 308, 1-10-7 Higashi Gotanda, Shinagawa-ku, 141-0022, Tokyo, Japan
Tel: 03-6450-4038 Fax: 03-6450-4065



Business Area

1. Professional consultation in clinical development.
    (Evaluation of current process, Measures for improvement, and overall proposal, etc.)

2. Evaluation of the study quality for NDA submission.
    (Evaluation of the data, materials, documents,etc., and execution of feasibility study.)

3. Support or advice for PMS activities, especially on drug safety information.

4. Development of computerized database system which will be applicable for daily activities in pharmaceutical company.
    (e.g., Management system for clinical development abiding by GCP, Medical scientific information system, etc.)

Please contact us if you have a plan to develop a database system to utilize it for your daily business. GPS will provide them by our own technologies, or we will make a service through consulting to develop them with you.



Products

Global Pharma System has several systems as the solution of daily practical business for pharmaceutical companies, CROs, SMOs, or medical institutions. These systems are all original products of GPS, developed by us based on our professional knowledge in clinical development.

GCP Super Manager

System to support daily activities for the development of new drugs at pharmaceutical company.

This system covers:

User of this system:

Pharmaceutical Companies, CROs.


Clinical QX Manager

System to support daily activities of QA or Auditing at pharmaceutical company.

This system covers:

Clinical QX Manager is an original product developed by Global Pharma System Inc. based upon very unique concept to assess the quality of clinical data, materials, and process of development whether the packaged document as the dossier is appropriate or not.
This system is useful to check off and evaluate the quality of the contents of all documents and the process of clinical development (monitoring, handling of test drugs, CRFs, agreements with institutions, and GCP compliances, etc.) that were carried out in accordance with GCP.
Clinical QX Manager also, detects the problem occurred during the execution of clinical study.
You are able to summarize and report the results of quality check or the audit results easily using this system. Clinical QX Manager is an effective tool to check the quality of daily activities and to execute the feasibility study before NDA.

User of this system:

Pharmaceutical Companies, CROs.


Central Doc Manager

Central document management system is a subset of GCP Super Manager. You can provide a complete filing of documents for NDA submission using this system.

User of this system:

Pharmaceutical Companies, CROs, etc.


MedStar

MedStar is an original product developed by Global Pharma System Inc.
This system covers all process to be carried out at medical institution complying with GCP where was announced in April 1997, and supports the process of clinical study. MedStar will lead a clinical study followed by GCP rules from the stage of study initiation to the completion of the study at medical institution.

User of this system:

Pharmaceutical Companies, Medical Institution, SMOs, IRB, CROs, etc.

Documents Download:

DocumentFile FormatFile Size
MedStar BrochurePDF2.65MB

To view Portable Document Format (PDF) files available at our site
you will require a free version of Adobe Reader.



Business Backgrounds

Tadaoki Suda, Ph.D (CEO)

1974Joined Ciba-Geigy Japan. (Medical Scientific Information Office)
1984Toray Co.,Ltd, Manager of Medical Science in Pharma Division.
1985Nihon Schering Co.,Ltd. Manager of Medical Scientific Information in R&D and Medical Division.
1986Manager of Administration of R&D and Medical Division (back to Medical Dept. in 1988)
1991Marion Merrel Dow Co.,Ltd. Manager of Regulatory Compliance Department in R&D Division.
1995Director of Project Management in R&D Division.
1996Hoechst Marion Roussel Co.,Ltd. Attached to the head of R&D.
1996Serono Japan Co.,Ltd. Director of Regulatory Affairs.
1997Founded Global Pharma System Inc.

Field of Specialty and Experience