Clinical Services Platform

- Medical Writing

- Clinical Monitoring

- Quality Assurance

- Data Management

- Statistical Analysis

- SMO Services/Subject Recruitment

- Testing Services

1、 Medical Writing

- Protocol development

- Final Report Writing

- Medical Coding

- Medical surveillance

- Adverse event and serious adverse event management

By communicating with clinical experts and NMPA review experts, the protocol developed by Cares' medical department is fully scientific and operational.

2、 Clinical Supervision

The clinical trial team of Cares consists of experienced clinical experts and clinical monitors from many specialties. They strictly implement the company's systematic, standardized and perfect SOPs and comprehensive quality control system (QMS) to ensure that the key procedures, key data, records and reports of the project fully comply with the requirements of the ICH-GCP and the Chinese GCP, so as to comprehensively satisfy the needs of domestic and foreign customers for clinical trials.

Cares' advanced monitoring technology, rich experience in clinical project management, good hospital partnerships and network of service organizations covering China can not only ensure the implementation progress of the project, but also effectively optimize the time of the clinical trial, saving valuable time for the customer's product launch.

Services 

- Monitoring of research centers and investigators

- Management plan (monitoring plan, risk management plan, project management plan, etc.)

- Clinical trial affairs management (investigator meetings, ethical application, HGRAC declaration and contract signing with research centers, etc.)

- Pre-trial, in-trial, and post-trial monitoring

- Project schedule management

- Quality control

- Monitoring of trial products and trial materials

- Monitoring of source data and source documents

- Monitoring of records and reports

3、Quality Assurance

The authenticity, consistency and completeness of the data is an important review basis for the successful registration of the project. Cares has an independent QA department under the direct supervision of the general manager and has established a comprehensive three-level quality management system.

Services

- Assist customers in developing quality management technical documents related to pharmaceuticals and medical devices

- Provide verification of compliance with quality management standards related to medical device and drug clinical trial programs, as well as causal verification

- Individualized verification plans based on clinical trial protocols for each project

- 100% data verification of key procedures and key data

4、 Data management and centralized monitoring

By adopting the electronic data collection system, Keris implements electronic data management for all projects and conducts centralized monitoring according to the authorization of research centers and investigators.

Centralized monitoring can identify high-risk clinical centers and source data, improve the efficiency of on-site monitoring and effectively avoid data irregularities.

Services

- CRF/eCRF design

- Data management plan and data verification plan development

- Database creation and validation

- Data entry and proofreading

- Programmatic data verification

- Medical verification and safety verification of clinical data

- Query raise and query closure

- Data quality control

- Blind auditing, database locking and transfer

- Serious Adverse Event (SAE) verification

- EDC system supports different data management processes, WYSIWYG eCRF design, real-time data collection and data sharing, in-system data verification and challenge posting, timely alerts for protocol violations and data logic errors, and data modification traces.

5、Statistical analysis

From protocol design to clinical summary report, biostatisticians are involved in the management of clinical projects to ensure accurate, timely and efficient services to meet customer needs.

Services

- Statistical consultation, protocol design and review

- Calculation of sample size and mastery

- Randomization procedure writing and blinding:

Determine the randomization methodology for clinical trials and provide a number of services related to the generation of randomized code lists, blinding and packaging of trial and control drugs, and secondary blinding.

- Statistical analysis plan development:

Develop a detailed and complete plan for statistical analysis, including: selection of data for statistical analysis, primary indicators, secondary indicators, methods of statistical analysis, etc., as well as expected statistical reporting forms, Template format for graphs and data tabulations.

- Statistical Programming:

Apply SAS software programming to generate statistical tables, charts and data lists.

- Statistical analysis report:

Write compliant statistical analyses, including: choice of methodology and its rationale, basic characterization, efficacy analysis, safety analysis, description of the implementation of SOPs, and audit reports.

- Interim analysis: as specified in the trial protocol, provide a preliminary understanding of trends in efficacy and safety across treatment groups, test the hypotheses in the trial protocol and whether sample size estimates are the validity of the hypotheses and sample size estimates in the trial protocol, etc.

- Pharmacokinetic analysis

- Regular reports on the clinical research process

6、SMO Service

Provide professional CRC services for drug, medical device and IVD clinical studies initiated by sponsors and research centers. Included:

Scope of Services

- Study center and PI research

- Ethical submission and follow-up

- Participating investigator meeting organization

- Subject recruitment and management

- Biological sample collection and pre-processing

- Trial data collection, recording and filling

- AE/SAE report

- Management of trial products, materials, and basic documents

- Project quality control

- Assist in closing  center

7、Testing service

Provide sample testing services for drugs, medical devices (including in-vitro diagnostic equipment), including:

- Customs and logistics services

- Selection of testing units

- Writing and validating quality standards or product technical requirements

- Signing of testing agreements

- Tracking test results and resolving testing issues