Service

1. Scope of data management service

• Data management consulting and training

• Paper and EDC project

• Case report form design

• Database creation and test

• Making data management plans

• Making data review plans

• Logic review programming and testing

• Double data entry and check

• Electronization of data and manual review

• Resolution of data queries

• Medical coding

• SAE consistency review

• Processing of exogenous data

• Database quality control

• Blinded data review

• Database locking

• Data extraction and transmission

• Preparation of data management report

2. Service team

Tigermed-Jyton Clinical Research and Evaluation Center (CREC) has a team which is sensitive to data, has a strong research design background, is good at data management, statistical analysis and medical evaluation of drugs and devices, and is especially experienced in protocol design, data management, statistical analysis and medical evaluation for medical devices. The team can provide professional and high-quality services in clinical trial data management, biostatistics and medical evaluation for domestic and foreign clients.

CREC has a close cooperation with the Data Management and Biostatistics Department of the group. Based on a perfect management system and standard operating procedures, CREC has passed the audit of 60+ clients at home and abroad, and completed 900+ projects for more than 400 clients at home and abroad.

3. Certificate of data management authorization

• The only CRO company authorized by MediData Rave® in China

• The first company in Asia which signed the CRO advantage projects with Oracle

• Have 10 Oracle certificates

• other certificates such as WHO-DD and MedDRA    

4. Main data management systems

• Oracle Clinical & Oracle Remote Data Capture

• MediData Rave

• InForm

• ClinstReport

• Clinflash

Statistical Analysis

1. Biostatistics service contents

• Offer comments to the Chinese Biostatistics Society as an authority, and participate in data standard setting, quality and biostatistics related projects of CFDA

• Communicate with the drug supervision administration in terms of statistics

• Clinical trial design and consulting

• Provide statistical support for the study protocol

• Calculate the sample size/power

• Randomizing scheme and coding

• Make statistical analysis plans

• Prepare templates of statistical tables, forms and lists

• Statistical programming

• Generate data analysis set

• Generate tables, forms and lists (TFLs)

• Interim analysis and statistical support for the Data Monitoring Committee

• Comprehensive summary and analysis of safety and effectiveness

• Statistical analysis report

• Statistical support for the clinical study report

• Statistical support for registration application

• Statistical support for journals of various therapeutic fields, conference materials, posters and manuscripts

2. Service team

Tigermed-Jyton CREC has a team which is sensitive to data, has a strong research design background, is good at data management, statistical analysis and medical evaluation of drugs and devices, and is especially experienced in protocol design, data management, statistical analysis and medical evaluation for medical devices. The team can provide professional and high-quality services in clinical trial data management, biostatistics and medical evaluation for domestic and foreign clients.

CREC has a close cooperation with the Data Management and Biostatistics Department of the group. Based on a perfect management system and standard operating procedures, CREC has passed the audit of 60+ clients at home and abroad, and completed 900+ projects for more than 400 clients at home and abroad by far.

3. Advantages of the biostatistics team

• The team has many international statistics professionals. The team members maintain low turnover and high growth.

• Senior statisticians have an average work experience of nearly 10 years in this field.

• The team is good at providing medical and statistical support for device application in the U.S., Europe, China and other countries and regions.

• The team has rich project experience. Hundreds of projects have passed the review and evaluation.

Medical Evaluation

1. Service contents

Medical science

• Assist in the design, execution, interpretation and modification of the clinical trial protocol

• Participate in the preparation of informed consent forms

• Participate in the preparation of the investigator’s brochure

• Assist in data analysis for the clinical study report

• Assist in the preparation of clinical study reports

Clinical trial operation

• Medical related training for the clinical trial protocol

• Training on relevant medical knowledge

• Subject enrollment review

• Protocol deviation review

• 24h medical consultation (emergencies)

Data management

• Medical review of CRF

• Medical code review

• Medical review of clinical trial data (data of medical history, adverse events, concomitant medication, and laboratory examination, etc.)

• Other medical support

2. Service team

Tigermed-Jyton CREC has a team which is sensitive to data, has a strong research design background, is good at data management, statistical analysis and medical evaluation of drugs and devices, and is especially experienced in protocol design, data management, statistical analysis and medical evaluation for medical devices. The team can provide professional and high-quality services in clinical trial data management, biostatistics and medical evaluation for domestic and foreign clients.

As a featured team of CREC, the Medical Evaluation Team has rich clinical background and clinical trial experience. The team provides professional medical monitoring services for the clinical trial, to ensure safety of the subject, guarantee that the research center strictly complies with requirements of ICH-GCP and the protocol and ensure that the clinical trial is scientific, complete and accurate.