Trial Data APP can upload source data to trial Data EDC. It has masking function to effectively ensure the privacy information security of the subjects. At the same time, the mobile APP can support online randomization and data entry.
Ensure data accuracy, and can be viewed at any time. Improve work efficiency and convenience.
Randomization
Investigators can open the mobile APP to complete randomization without time and space limitation.
Quick Data Entry
Quick data entry through mobile APP
Trial Data IWRS
Trial Data IWRS system can effectively manage the random distribution of drugs in multi-center clinical studies, and solve the problems of different progress of sub-sites across regions, expiration or surplus of drugs, and other issues. Investigators in different geographic locations can conduct subject enrollment, randomization, drug distribution and emergency unblinding operations at any time.
Multi-systems Seamless Connection
Supports two-way operation of mobile terminal and computer terminal, which is efficient and convenient. Multiple systems are seamlessly connected to meet the needs of one-stop clinical study.
Blind Distriubtion
To meet the management and dispensing requirements of blind projects, it can realize the dynamic management of drugs and reduce drug loss.
Intelligent Inventory Management
Intelligent inventory management and remaining shelf-life reminders to ensure efficient project operation.
Unblinding Online
Safe and reliable online drug unblind management.
Trial Data EDC
Efficient
Modular and quick eCRF set-up, rich template library
Support CDASH set-up
Support multi-field, multi-visit edit check
The system automatically checks before project launch
Intelligent
Support edit check rules configuration and lists cross-check no programming is required
Support cross-visit and cross-page verification
Support multi-field compound logic comparison
Support edit check replication
Diversified ways of queries reminder
Convenient
Soure deta-privacy processing, support remote monitoring
Mobile portal entry
OCR intelligent entry
Mobile portal randomization
One-time data entry, shared across the platform
Professional
21 CFR part 11 International Standard
GAMP5 system Verification Standard
CDISC Professional Member
IS027001 Information Security Management Certification
WHO-UMC International Certified Supplier
National Three-level Security Certification
Trial Data ePRO
Follow-up Reminder
Avoid the omission of human reasons
To reduce the rate of loss of subjects to
follow-up
Automatic Push Questionnaire
Subjects fill in online, support
subjects to fill in discomfort
records, etc., to reduce the lack of
key information for follow-up
WeChat Interaction between Investigators and Subjects
Provide real, reliable and
high-quality data sources
Perform quality control checks at
any time
Trial Data ERM Intelligent Risk Management System
Trial Data ERM can ensure that clients follow ICH-GCP GCP requirements and implement risk-based monitoring in projects;
Based on regulatory requirements and industry international standards, Trial Data quantifies and presents project risks through statistical algorithms, facilitating real-time monitoring and effective intervention by the project team.
Risk Monitoring
Analyze large quantity of data points to identify project risks
Automatic output of risk level, targeted countermeasures
Assist project management in real-time understanding of key project risks
Dynamic Monitoring
Project monitoring can be dynamically adjusted based on risk level
Automatically generate monitoring plans according to risk level and priority
It is convenient to improve the efficiency of CRA and help improve the quality of projects
Performance Management
Performance appraisal based on role
Query the performance of CRA/PM
User can filter the site to understand the past situation in project operation
Trial Data Medical Coding
Support medical-related dictionaries such as MedDRA, WHODrug, multiple search methods, batch coding and batch review, maintenance of thesaurus and query thesaurus, and coding within projects; support one-click upload of official dictionaries, assign permissions by project, automatic coding and manual coding Combine. The information system solves the problems of cumbersome manual coding process and inconsistency before and after coding, and also avoids possible mistakes in manual coding, effectively improving the efficiency and quality of coding work.
Support different therapeutic areas, different thesaurus dictionaries
Support different projects/sponsors to set the specified encoding path dictionary
Support for the same verbatim term summary encoding across multiple projects
Support account permissions according to project management
Supports automatic synchronization with all source systems
Trial Data STAT
The intelligent online statistical expert developed by us through the R language can complete statistical analysis online in real time without data export or statistical expertise, generate professional statistical charts and support online chart editing functions. Contains general description, univariate analysis, comparison, multivariate analysis, survival analysis, etc.