We have established a complete set of SOPs and management models that allows us to supervise and manage the entire process of clinical trials in accordance with international standards. We also strictly supervise the quality of the trials to ensure that clinical trials meet the GCP requirements, assuring they are authentic, scientific, reliable and traceable. With our wide distribution of offices and specialized PMs in various therapeutic fields, we have successfully completed over 500 clinical trial projects, including a number of innovative products.
Medical Writing
The medical writing team consists of dozens of excellent medical experts, writing specialists and statisticians. Core members have an average industry experience of more than 10 years and academic background of leading medical schools globally. Our innovative protocol design concept, scientific and rigorous work style, rich medical writing experience and effective SOPs have won the team a good reputation in the industry. Our service content includes the following:
1. Design of clinical trial protocols for medical devices / different phases of clinical trial protocols or unconventional study protocols for drugs
2. Preparation of clinical protocol related documents (e.g., case report forms, informed consent forms, and investigator’s brochure)
3. Preparation of clinical study report
4. Publishing papers on core journals
5. Preparation of medical materials for clinicians (e.g., questionnaire on updating treatment guidelines)
Clinical Monitoring
We have a monitoring team with more than 200 CRAs in China, and more than 800 CRAs globally. We can provide local clinical monitoring and site management services. We are familiar with the study site process, and provide more convenient support and more professional services for the study sites. Our services include:
1. Study site screening
2. Ethics Committee filing and approval
3. Study site clinical trial agreement negotiation
4. Study site initiation and close-out
5. Study site monitoring and management
6. Investigational product management
Project Management
We have a senior project management team with years of expertise in various fields such as medical aesthetics, cardiovascular, ophthalmology, AI, surgical robots, and oncology. We have built thorough analysis of the current situation and future developments in these fields. Relying on a strong medical team and years of solid cooperation with the study sites, we have accumulated unique advantages and rich experiences in the project management for innovative devices. Tigermed-Jyton is customer-oriented and adopts a project management model where the project manager serves as a one-stop contact point for the sponsors, assisting them in coordinating other functional teams to improve communication efficiencies. The project manager regularly analyzes the deviations between plans and actual progress, as well as manages and prevents risks, ensuring that the project proceeds as scheduled.
1. Preparation of project plan
2. Clinical trial risk management
3. Clinical trial document management
4. Clinical trial financial management
5. Clinical trial meeting organization
6. Project training
7. Relevant supplier management
Safety Vigilance
With stable and high-quality team members, our safety vigilance and medical monitoring team can provide professional services needed by the client. We also have an intact and mature SOP system and rich experience in international project management. We offer the following services:
1. Review the study protocol;
2. Develop safety management plan
3. Review CRF and conduct relevant medical training
4. Collection, collation and classification of SAEs
5. SAE reconciliation
6. Preparation of SAE reports and submission to relevant regulatory authorities and sponsors
7. Support safety review committees (SRC) and independent data monitoring committees (IDMC)
8. Periodic safety reports
9. Clinical trial summary report review
10. Post-market risk analysis report and re-evaluation report
Medical Monitoring
Our professional medical monitors can help the project team to better understand the objective, inclusion & exclusion criteria and process of the clinical trial, to provide medical support for the project team, and to ensure the safety of the subjects and the accuracy of the clinical trial data. The medical monitoring team will provide the following services for the client:
1. Draft / update the medical monitoring plan
2. Medical training (medical monitoring plan / protocol interpretation / knowledge of relevant disease areas)
3. Subject eligibility review
4. Regular medical monitoring meeting
5. Protocol violation / deviation review
6. Medical review for clinical data (adverse events, laboratory data, vital signs, medical history, and concomitant medication, etc.)
7. Medical consulting / Q&A Log maintenance
8. Review of clinical trial-related materials (clinical trial protocol, clinical summary report, and case report form, etc.)
9. Review of laboratory alert values
10. Data cleaning before database lock
Data Management and Statistical Analysis
Our DMSA team is data sensitive, has a strong study design background, and is good at DMSA of drugs and devices. We have a number of international statistical professionals. The team maintains a low turnover rate and high growth trend. Our senior statisticians have work experience of nearly 10 years in this field on average. We are expert in providing medical and statistical support for device submissions in the United States, Europe, China and other countries and regions, and have extensive experience with hundreds of projects.
Our Aata team holds the following data management authorization certificates:
1. The only CRO company authorized by MediData Rave® in China
2. The first company in Asia which signed the CRO advantage projects with Oracle
3. Hold 10 Oracle certificates
4. Other certificates such as WHO-DD and MedDRA
Our main data management systems include:
1. Oracle Clinical & Oracle Remote Data Capture
2. MediData Rave
3. InForm
4. ClinstReport
5. Clinflash
Our main data management services include:
1. Data management consulting and training
2. Paper and EDC project
3. Case report form design
4. Build and validate database
5. Develop data management plan
6. Develop data validation plan
7. Edit check programming and testing
8. Double data entry and check
9. Electronization of data and manual review
10. Resolution of data queries
11. Medical coding
12. SAE reconciliation
13. Processing of external data
14. Database quality control
15. Blinded data review
16. Database lock
17. Data extraction and transfer
18. Preparation of data management report
The range of biometric services we provide:
1. Offer comments to the Chinese Biostatistics Society as an expert, and participate in data standard setting, quality and biostatistics related projects of NMPA
2. Clinical trial design and consulting
3. Provide statistical support for the study protocol
4. Calculate the sample size / power
5. Randomizing design and coding
6. Develop statistical analysis plan
7. Prepare templates of statistical tables, figures and listings
8. Statistical programming
9. Generate data analysis set
10. Generate tables, figures and listings (TFLs)
11. Interim analysis and statistical support for the Data Monitoring Committee
12. Comprehensive summary and analysis of safety and efficacy
13. Statistical analysis report
14. Statistical support for the clinical study report
15. Statistical support for registration application
16. Statistical support for journals of various therapeutic fields, conference materials, posters and manuscripts
Computerized Digital Systems
We continuously and actively explore digital and innovative business models and make forward-looking arrangements. We can provide the following digital systems to our customers:
1. EDC – Electronic Data Capture System
2. IWRS – Interactive Web Response System
3. CTRM – Clinical Trial Remote Monitoring System
4. ePRO – Electronic Patient Reported Outcome System
5. eSafety – Pharmacovigilance system
6. CTMS – Clinical Trial Management System
7. eTMF – Electronic Trial Master File System
Third-party Audit
We have a complete quality management system for clinical trials of medical devices. Our audit team has an average industry experience of over 10 years. Our audit team members not only possess practical experience in the industry but also come from diverse backgrounds, including hospital institutions and national agencies. This allows us to conduct thorough evaluations of projects from a professional standpoint. The audit team is familiar with ICH-GCP and local authorities’ relevant regulations of medical device clinical study, experienced in quality management, able to comprehensively audit the clinical trial, and is actively providing high-quality audit service for clients.
Our range of services includes:
1. On-site audits for medical device clinical trials and in vitro diagnostic product clinical trials study sites, as well as office audits for study documents (TMF).
2. System audits and third-party supplier audits of such as SMO (Site Management Organization) and central laboratories.
3. Preparations and support for sponsor and NMPA inspections.
4. Establishment of GCP full life cycle quality management system (QMS) for sponsors.
5. Registration of medical device clinical trial institutions.
