Saama

Saama automates key clinical development and commercialization processes with AI, generative AI and advanced analytics, offering AI-backed SaaS solutions and services. Its products include BRAIN, Smart ClinSAP, Smart Data Quality, Smart Medical Coding, Patient Insights, Data Hub, Operational Insights, ContextIQ and Active Safety Analytics for Pharma.

Clinical Data and Statistical Programming

• Run biostatistics and statistical programming workflows in BRAIN, which centralizes these activities in one location.
• Prepare SDTM and ADaM artifacts, specifications, code and submission outputs through integrated programming workflows, including automated generation of ADaMs and TLFs for regulatory submissions. Clinical data management is supported by Smart Data Quality and Patient Insights for data review, and by Smart Medical Coding, which auto-codes MedDRA and WHODrug terms with peer review and an audit trail.

Clinical Operations and Evidence

• Manage trial operations through Operational Insights, which provides a centralized view of study operations, role-specific dashboards and surfaced trial insights.
• Support study start-up and site activation with tracked study, country and site milestones, and conduct feasibility and site-selection analyses to identify and qualify countries, sites and investigators. Saama also provides risk-based monitoring dashboards for central oversight across studies and RWE analytics for comparative safety and efficacy analysis, clinical study planning and population insights.

Commercial, Patient Access and Data Operations

• Measure commercial performance against brand KPIs, track formulary shifts that affect access, and analyze rebate tiers, deal structures and chargeback reconciliation.
• Support patient access operations with API-based medical and pharmacy benefit checks, EHR-driven prior-authorization workflows, patient-stall visibility and automated co-pay assistance matching. Saama also provides segmentation and call planning, next-best-action orchestration, KOL mapping, MLR review, modular content workflows and regulatory document generation for clinical study reports and trial master files.

Data Platforms, Quality and Managed Services

• Integrate clinical, operational and financial data in a Data Hub, and modernize legacy data warehouses into governed cloud-native architectures.
• Support quality teams by scanning closed deviations and CAPAs for recurring themes and drafting evidence-grounded investigation narratives. Saama also provides managed support for data platforms and analytics ecosystems, with tiered incident, request and change management aligned to service levels, plus digital and AI platform architecture strategy.

Best Fit

• Organizations seeking a combined technology and services partner for clinical data and statistical programming, trial operations, evidence analytics, commercial decision support and life-sciences data platforms.
• Teams that need centralized data workflows, operational dashboards, AI-supported analytics or managed data-platform services across clinical development and commercialization.