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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: Average of 12+ years of industry experience, with management expertise in renowned domestic and international enterprises and academic institutions.
Core Technical Team: Extensive experience in innovative drug projects, with an average of 8+ years of professional experience.
Senior Consultants: Statistics professors from academia, and senior industry experts in statistics and technology.
Compliance with international CDISC standards and ICH-GCP guidelines.
Utilization of globally recognized data management and statistical analysis platforms.
Extensive experience across major therapeutic areas, including but not limited to: Oncology, Immunology, Metabolic Diseases, Cardiovascular, Infectious Diseases, Respiratory, Neurology, Ophthalmology, and Psychiatry.
Solid project experience in specialized fields, including Cell and Gene Therapy (CGT), Nuclear Medicine, Rare Diseases, and Real-World Studies (RWS).
Diverse engagement models including: Full-Service Biometrics, Functional Service Provision (FSP), Strategic Partnership, Expert Consulting & Training, Oversight, and Staff Augmentation (Insourcing).
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