Clinical Investigation | 디엔에이테크퍼시픽-DNA TECHNOLOGIES PACIFIC                        
DNA Technologies Pacific

ring_volume  Phone : +82 2 6749-1161

forward_to_inbox  E-mail : info@dna-tec.org

Search in Boards

사이트 내 전체검색

Clinical Research

CS Center

Tel. 02-6749-1161

AM 9:00 ~ PM 6:00

* Saturday,Sunday,Holiday : Days Off

Fax 02.6749.0711
info@dna-tec.org

Clinical Investigation


❉ ❉ ❉

What is a Clinical Investigation?



Medical device manufacturers must meet the requirements of ISO 14155 when conducting clinical investigations to demonstrate the safety and effectiveness of their products for use purposes.



  • 1. The clinical investigation evaluation data shall include the following

    -  Risk assessment
    -  Evaluation of justification for a designed clinical investigation
    -  Clinical investigation plan
    -  Investigator's Brochure
    -  Case Study Report
    -  Monitoring plan
    -  Reasons for selecting a place for clinical investigation
    -  Consent
    -  The method of identified clinical subjects
    -  Data Review Committee


  • 2. The clinical investigation shall be carried out in accordance with the clinical investigation plan. Approval in accordance with clinical investigations varies from member countries of the European Union.

    -  You must have information about the initial clinical investigation site.
    -  Periodic monitoring of clinical investigation sites is required.
    -  Include data on side effects, device defects, etc.


  • 3. The clinical investigation document shall include the following.

    -  Modifications
    -  Subject identification table
    -  List of clinical investigation teams and other personnel
    -  Confidentiality contract for the subject, etc

DNA TECHNOLOGIES PACIFIC Business

  • 01Safety and efficacy clinical trials for CE certification of medical devices

  • 02PMCF progress on CE certified medical devices

  • 03Support the PMCF Plan, Protocol, and Investigator's Brochure

  • 04Collect health and economic data to obtain approval for reimbursement

  • 05System and product certification technical support

SYNOPSIS/PROTOCOL



  • 1. Clinical Investigation Plan

    For clinical investigation, protocol and synopsis shall be prepared that describe the rationale, objectives, design, methodology, monitoring, statistical considerations, organization and conduct of a clinical investigation.


  • 2. The Protocol shall consist of the following content :

    -  Identification of the clinical investigation plan
    -  Sponsor
    -  Investigation information (Investigator, Site, etc)
    -  Synopsis
    -  Medical Device information
    -  Risks and benefits of the medical device and clinical investigation
    -  Objectives and hypotheses of clinical investigation
    -  Design (Subjects, Procedure, Monitoring Plan)
    -  Statistical considerations
    -  Data management
    -  Deviation from clinical investigation plan
    -  Statements of compliance
    -  Informed consent process
    -  Adverse events / effects
    -  Population
    -  Suspension of premature termination of the clinical investigation
    -  Bibliography
    -  Etc


  • 3. Synopsis for clinical investigation shall consist of the following :

    -  Inclusion/exclusion criteria
    -  Number of subjects
    -  Duration of the clinical investigation
    -  Follow-up
    -  Objective(s)
    -  Endpoint(s)
    -  Etc

DNA Technologies Pacific – Plan service

  • 01DNA Technologies Pacific provide configuration and preparation services for Protocol and Synopsis for Clinical Investigation.

  • 02We can provide customized clinical guides with years of experience and qualified technical experts and will assist you in the preparation of the overall documentation to be submitted for prior approval of the relevant authorities and IRB.

The Investigator’s Brochure(IB)



  • 1. Introduction of the Investigator’s Brochure
    The Investigator’s Brochure is a document that consists of the clinical and non-clinical data relevant to the study of the medical device.

  • 2. Purpose of the Investigator’s Brochure (IB)
    The main purpose of the IB is to provide investigators, clinicians and other experts who are involved in the process of the clinical investigation, with necessary information such as dose, dose frequency, visiting interval, method of administration, safety monitoring procedures etc. The information according to the GCP (Good Clinical Practice) should be presented in ‘a concise, simple, objective, balanced and non-promotional form’.

  • 3. Who prepare and Who assess?
    Investigator’s Brochures should be prepared by the sponsor. A medically qualified person should also participate in editing of the IB, but the final approval of the content of IB should be made by researched who generated the data. The IB should be reviewed and revised annually, more frequent revision of the IB data may be appropriate in case of the generation of relevant new information regarding the medicine or medical device.


  • The information IB should include :

    -  General
    • ①  Introduction
    • ②  Identification of the IB
    • ③  Sponsor/Manufacturer

    -  Investigational device information
    -  Preclinical Testing
    -  Existing Clinical Data
    -  Risk Management
    -  Regulatory and other references

DNA Technologies – Investigator’s Brochure Development Service

  • 01DNA Technologies consists of the qualified and experienced team of experts who are ready to conduct Medical Device clinical studies, provide medical monitoring, create clinical investigation protocol design, and adapt our services to support the specific needs of every client. Among the services we can offer is an Investigator's Brochure development service.

  • 02Originally an Investigator’s Brochure should be prepared by sponsor/manufacturer, but as soon as it’s not easy to combine all information together and create a right documentation that will comply with all necessary standards, for this reason, the personnel of DNA Technologies Pacific who have a quite wide range of experience in CRO tasks can help with the Investigator’s Brochure development.

Clinical Investigation Report



The clinical investigation results report is a document that contains a wide range of details on the planning, method and performance of the test to clarify how the test was conducted. This report provides a clear description of the design features of the study according to how they were selected and includes test results. The clinical investigation report should also contain sufficient patient data.



  • The clinical investigation report shall include the following :

    -  Cover
    -  Table of contents
    -  Clinical investigation summary
    -  Introduction to ongoing clinical investigations
    -  Description and method of clinical investigation equipment
    -  Clinical investigation plan
    -  Results
    -  Conclusion
    -  Abbreviations and definitions
    -  Ethical considerations
    -  The tester and administrative structure of a clinical investigation
    -  Signature
    -  Appendix

Experts from DNA Technologies Pacific support planning for clinical investigations, manage and monitor clinical investigations directly, and provide customized clinical services to companies so that clinical investigations can be completed quickly.

Services related to clinical investigation of DNA Technologies Pacific

  • 01Support preparation of clinical investigation plan

  • 02Management of clinical investigation data

  • 03Support for clinical investigation design

  • 04Review protocol and synopsis

  • 05Manage subject data

Quick Menu