Service

Clinical Operation

 Overview

Tigermed-Jyton has always been devoted to providing integrated technology and support for clinical trials intended for the registration of medical devices and IVD products. We will support your registration or pre-marketing study from protocol design, center screening, recordation & approval, center startup, monitoring management, data collation, statistical analysis to summary and the end.

To standardize supervision and administration for medical device clinical trials, the National Medical Products Administration (NMPA) released the Good Clinical Practice (No. 25 NMPA Order) on March 23, 2016 and Inspection Items and Judgment Principles for Clinical Trials of Medical Devices on November 28, 2018. With the implementation of various policies, more professional and normative clinical operation teams are required for clinical trials of medical devices.

Basic principles of clinical trials: Scientific, authentic and compliant

1. Service Contents

SSU:    Screening of Clinical Investigation Sites

                 Project approval of Clinical Investigation Sites

Obtaining ethical approval documents for clinical trials

Project execution:    Center startup

Routine monitoring for clinical trials

Investigational product management for clinical trials

Coordination & cooperation of CRC

Project management: Project management for clinical trials

Risk management for clinical trials

Financial management for clinical trials

Organization of clinical trial meetings

Project training

Clinical approval

Recordation with the Genetics Office

CTA: Document management for clinical trials

2. Clinical Operation Guarantee:

Scientific assistance: The project team is guided by senior registration managers & medical managers & the data management & statistics team during the process.

Efficient communication: The status report of the project team and the assistance team is updated every weak, to ensure that all participating departments timely know the project progress, feedbacks and suggestions;

Perfect system: SOP in line with international company standards, regular QC & QA inspection, clear rewards and punishments for document management;

Thoughtful plan: Progress plan and deviation analysis, risk control and prevention, resource allocation, guarantee for scheduled project implementation;

3. Organization Structure of Clinical

Operation: