Clinical Test Service

Jiangxi Chiyan related companies are committed to providing a full range of clinical research services for global customers, including drugs, biological products, medical devices, in vitro diagnostic reagents and other pharmaceutical products, covering phase I-IV & BE (Bioequivalence). From Phase I clinical research to final registration, through strict quality control system and experienced professional team, we help innovative and breakthrough medicines and medical products to market as soon as possible and benefit patients.

Early clinical service 

Solutions can be professionally tailored to each project. Our goal is to speed up the drug development process and provide a one-stop service while maintaining quality. The experience and expertise of our team enables our clients to have a quality clinical development experience.

Our Phase I center conducts Phase I clinical studies, bioavailability and bioequivalence trials of innovative drugs. The center is NMPA accredited and is staffed with full-time researchers, physicians, and nurses to provide care to subjects. Our subjects include normal healthy volunteers (NHV), as well as patients with cardiovascular, endocrinology, oncology, respiratory, and diabetes-related conditions.

We are able to provide our customers with flexible and innovative solutions for early stage drug development, from compound selection to proof of concept. In addition, it can seamlessly integrate new drug research and development and global declaration. Combine world-class CRO services with cross-functional project management and global regulatory expertise to support IND filings. Together, we offer a full range of solutions, including clinical pharmacology, FIH and proof-of-concept trials, supporting and conducting a full range of early stage clinical services.

Our main business areas include 

• Bioequivalence test 

• Bioavailability tests 

• Single and multi-dose escalation studies of FIH 

• Proof of concept test 

• Pharmacodynamic (PD) studies 

• Pharmacokinetic (PK) studies 

• Drug interaction studies 

• Confirmatory PK studies 

• PK research for special populations

Clinical operation service

Jiangxi Chiyan provides customers with a full range of clinical operation services, from early clinical research to the final approval and listing of new drugs. Our professionals have a commitment not only to our sponsors, but also to patients, doctors, researchers and regulators. When assembling a team for your study, we refer to our trial experience and treatment expertise to ensure we have the right solution for you and your trial.

We provide high-level management and clinical development services for all phases of drug trials, as well as devices, IVDs and vaccines. In the past time, Jiangxi Chiyan has established long-term stable partnership with a number of customers, providing high-quality and efficient projects to help customers implement product development strategies. The level of research start-up delivery was rated as industry-leading by several sponsors. We provide 24/7 support and comprehensive clinical services to our clients.

Services include 

• Project Management 

• Selection and start-up of test centers 

• Patient recruitment services 

• Clinical research center supervision and management 

• Clinical trial self-examination and verification support (China) 

• TMF document management 

• Quality control services

Clinical data management and statistical analysis 

The Sino-US service team of Jiangxi Chiyan Biostatistics has decades of experience and rich industry knowledge, which can meet the specific data management and statistical analysis needs of customers in the trial. It can not only efficiently complete the project within the established time and budget, but also provide accurate and complete clinical data and give customers a full range of clinical trial statistical services. At present, there are about 100 team members in China and the United States, with rich and professional project experience. 30% of the team members have global project experience and 40% of the team members have oncology project experience. Mathematical statistics and management analysis team has many years of working experience in foreign pharmaceutical factories and CRDMO, and has a perfect organizational structure and training system. The team members are experienced, the project cooperation is high, the delivery quality is reliable, and the customer relationship is good. It is an efficient and professional team.

Clinical data management and statistical analysis services include 

• Biostatistical consulting and analysis 

• Data strategy recommendations for registration; Clinical trial design and optimization; Data integration strategy for regulatory documents 

• Support/observational research in medical affairs 

• Formulation of scheme and statistical analysis plan 

• CDASH based CRF design 

• Establishment and application of EDC database

1.Medidata RAVE EDC and related modules 

2.IBM eCOS and related modules 

3.OmniComm TrialMaster 

4.Inform 

5.DataLabs 

6.OpenClinica 

7.iMedNet

8.Medrio 

9.Taimei EDC0 and 5.0.

·Establishment and application of IRT system

·Medidata Balance

· IBM Randomization, Inventory

•Establishment of CTMS system

Medidata CTMS

• Medical coding

1.MedDRA

2.WHO Drug

• Data management status reports and lists, including project-specific KPIs and trends 

• Study quality control in the direction of trial risk monitoring 

• List of medical monitoring 

• Provide Patient Profile reports and Patient Narrative 

• Data monitoring, anti-fraud detection

• Data mining, Meta analysis

• Data warehousing and data integration 

• Expert review and statistical evaluation

• All data meets submission requirements (CDISC) : 

1.SDTM (periodic transmission during the project) 

2.ADaM 

3.Define.XML 

4.Data Auditor Manual 

• Conversion of traditional data to CDISC standard data such as SDTM, ADaM 

• CSR, SAR writing 

• Submit 

1.ISE/ISS 

2.eCTD 

• DMC support 

• Provide analysis services for comprehensive summary of safety and efficacy 

• FDA annual safety report 

• US Clinical Trial Registry (gov) and European Clinical Trial Registry (EudraCT) data

Medical affairs 

Medical consulting and monitoring services 

Chiyan medical team consists of tenured physicians as well as experts in the therapeutic field, with experience in a wide range of therapeutic fields, from research design, protocol development, medical monitoring, and a variety of other scientific matters. Dr. Alfonso Alanis, medical Chief Officer of the US team, also has more than 34 years of clinical research and development experience, covering all important treatment areas and the entire development cycle, especially the inclusion of ethnically balanced populations. Our team is available to provide the necessary guidance to the project team to ensure that drug development is carried out on time and on budget. Team members are located in North America, China and the European Union.

The services provided by Medical Affairs include but are not limited to the following 

• Scientific advice in the field of medical specialties 

• Research design 

• Solution development 

• Medical and total monitoring 

• Project team training and support 

• Medical data review and trend analysis 

• Security assessment 

• Clinical research reports

Clinical pharmacological analysis 

Jiangxi Chiyan Clinical Pharmacology team members are from well-known domestic pharmacokinetics experts, doctoral and master's degree students, among them, the average core members of the team have more than 5 years of pharmacokinetics related work experience. The CP team provides protocol design, PK/PD modeling, and PK report writing services for clinical trials. The CP team has accepted and passed the audit of the National Bureau for many times, and has a good compliance concept.

Clinical pharmacology services include 

• Bioequivalence tests (high variation, narrow therapeutic window, endogenous drugs, etc.) 

• Phase I clinical trials (FIH, SAD, MAD, Food effects and DDI, etc.)

• Phase III clinical trial protocol (Pop PK protocol design)

• Pharmacokinetic parameter calculation (non-atrioventricular and atrioventricular models)

• Preparation of pharmacokinetic study plan and pharmacokinetic analysis report

• PK model prediction and individual PK/PD modeling

Medical and scientific writing services 

The qualifications of our medical writing team members include postdocs, PHDS and masters, and the team members have an average of more than 5 years of extensive writing experience on multiple indications and study types. With our global clinical experience and expertise, we aim to provide our clients with the best writing services. Our team members can write easy-to-read documents from multiple data sources, while keeping the style, presentation, and message of the full text consistent. Our team members have high project management and communication and coordination skills, can reasonably accept the feedback of the sponsor, complete the work in strict accordance with the schedule, and finally submit a complete document that is accurate and clear and combines the opinions of all parties. Our writing team can write many types of documents for you, including but not limited to:

• Clinical trial protocol 

• Clinical trial summary report

• Researcher Handbook 

• Registration application 

• Publications 

• Laboratory manual 

• Medication instructions 

• Informed consent 

• Research Handbook 

• Medical device evaluation report

Pharmacovigilance 

Jiangxi Chiyan pharmacovigilance team has more than 100 domestic and foreign project experience. Most of the team members have several years of experience in large foreign enterprises and CRDMO, and the average working years of pharmacovigilance are more than 5 years. Pharmacovigilance team adhering to the concept of customer first, integrity as the basic principle, to provide customers with compliance, professional and high-quality services, including pre-market and post-market drug, medical device pre-market and post-market safety management services for the entire life cycle of medical devices.

Pharmacovigilance team services include:

• Establishment of warning system for medical equipment 

• Safety data management during clinical trials 

• Post-market security data management 

• Secure database system services 

• Security signal detection and evaluation 

• Development Phase Safety Update Report (DSUR) 

• Risk Management Plan (RMP) 

• Regular Security Update Report (PSUR) 

• Medical equipment safety training

Registration transaction 

Jiangxi Chiyan registration team is committed to accelerating the development and listing of medical and health products for the benefit of patients. We provide registration and advisory services covering the entire life cycle of pharmaceutical products including pharmaceuticals (chemicals, biological products and proprietary Chinese medicines), medical devices (including in vitro diagnostic reagents) and health food. Our registration services cover China, the United States, Canada, and major countries and regions around the world.

Our registration affairs experts have more than 10 years of registration management experience, have a deep understanding of the changing local regulatory environment, understand the development process and technical requirements of pharmaceutical and health products, and maintain good communication with the regulatory authorities, which enables us to choose the right development path and appropriate registration strategy. Submit declaration documents that meet regulatory requirements and product characteristics to ensure smooth and efficient product registration.

The registration transaction services we provide include 

Registration consultation 

• Product development and registration consultant 

• Registration feasibility assessment 

• Registration policy and plan development 

Pharmaceutical product registration

• Application data writing and data defect analysis 

• Application data integration and publication (including eCTD) 

• Registered agent 

• Clinical trial application (Pre-IND, IND, IDE, ITA, CTA, etc.) 

• Listing Application (Pre-NDA, NDA, BLA, ANDA, 510K, PMA, MAA, etc.) 

• DMF registration (APIs, pharmaceutical excipients and pharmaceutical packaging materials, etc.) 

• Registration certificate maintenance 

• Supplementary application 

• Orphan drug designation

• Expedite the approval of applications 

• Breakthrough therapy identification 

• Pediatric drug clinical trials 

• Scientific advice application 

• Annual Report 

• Trial registration

Quality system management and consulting 

Jiangxi Chiyan's quality management system focuses on the control of research-specific risks, ensuring the integrity of data and the protection and safety of subjects. We achieve this by incorporating quality management principles, GCP guidelines and regulatory requirements into our internal processes such as standard operating procedures, job descriptions, and employee training guidelines.

Our quality assurance program includes compliance audits, maintenance of procedural compliance and compliance with regulations, and collaboration between departments. This operational synergy ensures protocol compliance, identifies quality risks, and helps identify clinical research project-specific training.

The audit team members of the Quality Assurance Department of Jiangxi Chiyan have 5 to 10 years of working experience in the field of clinical research, and have in-depth and solid systematic knowledge and practical experience in the operation and management of clinical research projects, quality management and quality assurance, inspection and meeting the inspection of pharmaceutical administration. In total, the team has implemented more than 50 project audits and welcomed more than 8 Chinese and American drug administration inspections, all of which have passed successfully.