Statistical programming services

We are providing end to end services for your programming needs. CRF Annotation, Edit checks, CDISC Standard Implementation SDTM & ADaM, TLF’s (TLG’s) Programming, CDISC Validation Report, Define.XML, Reviewer Guide like SDRG & ADRG.

What we do

Standardized Data (SDTM)

Standardization of study data is needed for submission to regulatory authorities or to integrate with other systems such as data warehouses. We have years of experience in assisting customers to transfer clinical
data in CDISC SDTM (Study Data Tabulation Model) format or other customer-specific formats.

ANALYSIS DATA (ADaM)

Analysis data are needed for submission to regulatory authorities and the generation of analysis outputs. We have years of experience in assisting customers to transfer clinical data in CDISC ADaM (Analysis Data Model) format or other customer-specific formats.

Analysis Outputs (TFLs)
Analysis outputs (Tables, Figures and Listings, TFLs) are required to perform the analysis for a clinical trial. We have years of experience in assisting customers to create TFLs per the requirements of a specific clinical trial.
Data Integration
Axial the Data Analytics has helped customers with many integrated safety (ISS) and efficacy (ISE) summaries for submission to regulatory authorities.
Independent Quality Review
Axial the Data Analytics has assisted several customers to perform independent quality review on deliverables produced by an external party. This helps the customer ensure quality of deliverables and avoid costly rejections or time delays later in the approval process.

Reports

Axial the Data Analytics is well equipped to produce periodic and safety committee reports, for example for DSURs and DMCs.