AI-Powered Clinical Programming

Empowering Solutions

We offer comprehensive end-to-end statistical programming solutions that can be tailored to your specified timelines and budgets

Data management services:

• Case Report Form (CRF) design

• Annotated CRFs to CDISC standards

• Data Edit Checks

• External vendor data reconciliation

• SAE reconciliation

• Protocol deviation listing

• Data visualization

• Risk based monitoring

• Patient profile

Statistical Programming

• Statistical tables, listings, and figures

• Sample size calculation

• Randomization schemes

• Interim analysis

• Periodical reports (IDMC, DSUR, IB)

• Data exploration

• Automated MRL

• PK/PD analyses

• Inspection BIMO

Regulatory Submission Services

• CDISC Conformance Consulting

• SDTM mapping and documentation

• ADaM analysis dataset creation

• ISS / ISE summaries

• Define.xml

• Annotated CRF

• Reviewer's Guide (cSDRG, ADRG)

• Legacy data conversion

• NDA/BLA submission to FDA, EMA, PMDA

Expert Programming

Specializing in CDISC implementation and clinical programming for drug discovery.

Data Analytic Solutions

Utilize AI technology to streamline data processes and enhance efficiency in clinical programming.

Programming Staffing Services

Expert programming staffs available for drug discovery projects and regulatory filings on demand.