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UnionClin’s Data Management and Statistics team (operating under the subsidiary UnionClin Laiya) offers professional and customized biometrics services. With extensive experience in domestic and international clinical trial projects, we create value for clients through an integrated clinical data platform TrialMaster. As a CDISC enterprise member, we can better utilize global resources to support clients in internationalizing clinical development and global electronic data submissions.
Statistical consultation for clinical development strategy
Trial design and clinical protocol statistical writing support
Design and implementation of randomization schemes
Development and implementation of Statistical Analysis Plan (SAP) and statistical analysis Tables, Figures, and Listings (TFLs)
Study result Interpretation of and report writing
Support for communication with regulatory authorities
Independent third-party statistical services for IDMC/DSMB
Biometrics consultation and training
Data management document writing
CRF/eCRF design and EDC build
Clinical data management systems and related modules Build and testing
Online data cleaning and data status reporting
Offline data programming and manual review
Medical event and drug coding
External data reconciliation
Serious Adverse Event (SAE) data reconciliation
Protocol deviation management
(Blinded) data review meeting management
Database lock and raw data delivery
CDISC standard data (SDTM/ADaM)
Statistical analysis Tables, Figures, and Listings (TFLs)
Interim analysis and statistical support for IDMC
New Drug Application (NDA/BLA) eCTD M5 electronic data submission (including Case Report Form (CRF) annotations, SDTM, ADaM, Define files, cSDRG, ADRG, etc.)
Integrated Summary of Safety/Efficacy Analysis (ISS/ISE)
Electronic data capture (TrialMaster EDC)
Medical coding (Auto-Encoder)
Laboratory range management
Randomization and drug dispensing (IRTMaster)
Supports for other international and domestic mainstream electronic systems, such as RAVE and eConnect
Innovative study design
CDISC standards implementation for entire trial process
Risk-based monitoring (RbM)
Data visualization tool development
Core Management Team: 15+ years of industry experience with management practice in well-known pharma and CRO at home and abroad
Core Technical Team: 8+ years of industry experience in projects of innovative drugs
Senior Consultants: Professors from academia, senior statisticians and technical experts in the industry
Compliance with ICH-GCP and CDISC global standards.
Use of global data management and statistical platforms.
Biometrics full services, Functional Services, Strategic Partnership, Consulting, training and ad-hoc support, Oversight, and insourcing model.
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