Clinical
Saama offers industry-leading AI and advanced analytics-based custom solutions and services that cover the entire clinical trial lifecycle. Our expertise and proven frameworks help us create specialized solutions that accelerate clinical trials, while improving quality and reducing costs.
Biometrics
Accelerate your time to regulatory submission.
Statistical Programming Services
Accelerate CDISC SDTM data transformations.
The Challenge
A top 5 pharmaceutical company had well-established — but inefficient — processes to transform raw data into SDTM format. Automating and outsourcing this process would allow them to accelerate their time-to-market at the end of their trials.
How Saama Helped
Saama implemented Source to Submission (S2S), automating the complex SDTM mapping process with artificial intelligence (AI) and machine learning (ML). This eliminated much of the manual work done by SAS programming teams, and also reduced timelines from six weeks to three weeks while maintaining the same data quality. Saama provided resources to conduct the automated mappings, further reducing the burden on internal resources.
Impact
Reduced SDTM mapping timelines by up to 50%
Regulatory Submissions
Accelerate submissions by automating ADaM and TLF generation.
The Challenge
A Top 5 global pharmaceutical company was looking for an end-to-end statistical programming and analysis solution that would automate the transformation of raw clinical trial data into Analysis Data Models (ADaM) and Tables, Listings, and Figures (TLFs) for regulatory submissions.
How Saama Helped
Saama built an end-to-end solution that replaced paper-based study specification documents with digital specifications, enabled the use of multiple programming languages beyond SAS in a single environment, and automatically transformed raw data into CDISC SDTM format for ADaMs. The solution also allowed for “no-code” development of TLFs — based on analysis results — eliminating the need for statistical programming of TLFs.
Impact
Automatic generation of ADaMs and TLFs for regulatory submissions.
