SERVICES
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法规注册

医学事务

临床监查和项目管理

数据管理和统计分析

生物样品分析

 

 

Advantages

The core team is able to explore and establish regulatory pathway in new areas. The core members have more than 20 years of experience in drug and medical devices registration. We could accurately understand the regulation and future development trend. Long term working relationship and efficient communication channels with the regulatory authority.

Regulatory Affairs

Medical Affairs

With highly experienced medical experts and writers, the Medical Affairs team can provide excellent services, including Clinical Development Plan, protocol writing, other medical documents. The team can also provide medical monitoring services.


Service Scope

Clinical development strategies of phase I-III studies
Medical Writing services, including Phase I-III/IV/BE protocols, IB, and Clinical Study Report
Writing for preclinical data package
Very experienced in medical writing of both generic and innovative drugs
Reliable clinical R&D strategies and clinical trial protocols supported by the knowledge and experience of internal statisticians and pharmacokinetics experts

Advantages
All the team members have Master degrees or above.
The core team members have 10-20 years of experience.
Be able to provide reliable clinical R&D strategies for products in different therapeutic areas
The Medical Writing team was involved in hundreds of Phase I-IV protocol writing.

The Medical Writing team has successfully published English articles in key journals.

Clinical Monitoring and Project Management

CR Medicon has a fast growing clinical operation team, consisting of over 30 people for now. The team has extensive cooperation with well-known domestic clinical trial institutions and KOLs, and has rich experience in Phase I-III, BE trial monitoring and management.

3 co-managed phase I centers, including Heze City Hospital of Traditional Chinese Medicine, Heze City, Shandong Province Zhengzhou Hongda Cardiovascular Hospital, Zhengzhou City, Henan Province, and People’s Hospital of Xinzheng, Zhengzhou City, Henan Province. CR Medicon can provide reliable early phase study support with high quality, well-controlled budget, and within the timeline requirement.


Advantages

The team has strict quality system and integrated SOP system
All the staff have medical related education background. More than half of them have Master degrees.
Good staff stability (the team turnover rate of 2017 is less than 10%)
Rich experience in phase I-III studies of innovative drugs and BE studies
Participated in the implementation of some scientific frontier projects, including tumor immunology, cell therapy, biosimilar, etc. [Chinese and English contents currently do not match]
3 co-managed phase I sites, with a total of more than 200 hospital beds

Data Management and Statistical Analysis

There is no doubt that data management and statistics team of CR Medicon is the best partner you are looking for. Strict quality standards, experienced team members, and rich iproject experience in US/China, extensive knowledge in multiple EDC platforms, these have made CR Medicon the best DM and Stat service provider for our clients.


 

Statistical Analysis

Statistical Analysis Plan development
Randomization plan development
CDISC SDTM/ADaM development
SAS Programming
Exploratory analysis
Interim analysis
DMC related statistical services
ISS/ISE
Statistical Analysis Report (SAR) development

 

Data Management

CRF, eCRF design
Randomization and Drug Supply System design
Database design, set-up, UAT and maintenance
Double data entry and reconciliation for paper studies
Data verification and query management
Medical coding, SAE reconciliation, external data management
QC and auditing of data management

Service Scope

Project Preparation Stage

Clinical trial design
Sample size calculation
Authoring biometrics related sections in the protocol

 
 

Distribution of experience

Advantages

Over 70 members in this team, lots of them have more than 5 years of experience,. The core members have 10-20 years of experience
Rich experience in Phase I-IV studies, BE studies and real world observational studies
Rich experience in global and local studies, and FDA/EMA NDA/BLA ISS/ISE preparation
Accredited Partner of Medidata, the largest global EDC company

Data management and statistical analysis team members are very familiar with Rave, Balance and other electronic systems.
For BE studies, the team are able to quickly produce high-quality statistical analysis reports.

Most of the team members have lots of CDISC implementation experience, nearly half of the ongoing studies are CDISC studies

BIO-ANALYSIS

CR Medicon has invested heavily to establish a high standard bio analysis laboratory with advanced equipments , strict QC system, experienced operation team and famous drug metabolism scientists. We commit to providing customers with FDA/CFDA GLP compliance services.


Service Advantages

Follow FDA/CFDA GLP requirement
A Bio-Analysis laboratory with more than 11,000 sq. ft
Watson LIMS laboratory management system, a well recognized system in the industry
Equipped with 8 LC-MS/MS, including 6 mass spectrometers of AB Sciex 5500, 2 mass spectrometers of 6500,4 Waters UPLC and 4 Shimadzu HPLC
Bio-Analysis for phase I to III trials and BE studies
An excellent scientific and lab management team, rapid development and verification of methodology