Service

Tigermed-Jyton is experienced in providing clinical trial services for medical devices. Tigermed-Jyton can provide clinical technology services including clinical trial, evaluation and scientific research, etc. for the client in accordance with current regulations, GCP and corresponding guidelines:

•  Clinical study design

•  Registered clinical trial

•  Clinical study at the R&D stage or after marketing

•  Registered clinical evaluation

•  Internal/third-party audit of clinical trials

•  Scientific strategy study

Service contents:

•  Design and evaluation of clinical trial strategies

•  Design and evaluation of clinical trial protocols (sample size statistics)

•  Selection of Clinical Investigation Sites

•  Preparation and tracking of ethical materials

•  Preparation, application and tracking of materials for the Genetics Office

•  Clinical trial filing

•  Investigator’s brochure

•  Informed consent form

•  Original case

•  EDC

•  Data management

•  Clinical trial monitoring/the third-party monitoring

•  Data statistics

•  Quality control

•  Preparation of the clinical trial report of the subcenter

•  Preparation of the final report for the clinical trial

•  Meta-analysis/document retrieval

•  Data detection (CRC service)

•  Clinical evaluation report

•  Preparation of scientific strategy

•  Developing strategy combined with concomitant drugs and diagnosis

•  Literature review

•  Meta-analysis/document retrieval

•  Project strategy evaluation/feasibility evaluation report