Clinical trial data is regulatory evidence. Systems that lose data or can't prove chain of custody don't get approved. Drug discovery AI looks brilliant and crashes on real molecular chemistry. Real-world evidence pipelines are nightmares of vendor integrations. Consult Saksham has built systems that survive FDA audit, handle GxP compliance by design, and don't cut corners on data integrity.
GxP compliance by architecture not policy, clinical trial data provenance and audit trail integrity, drug discovery model explainability and safety, real-world evidence cohort definition and data harmonisation. The practice has shipped systems that regulators approve and that don't require compliance theatre.
GxP compliance can't be added after build. Consult Saksham has architected systems that enforce data integrity, maintain immutable audit trails, and document every assumption, systems that pass FDA inspection without surprise rework.
AI predictions aren't enough. Chemists need to understand why a molecule was proposed. Consult Saksham has built discovery AI that's both accurate and interpretable, models that make suggestions chemists can reason about.
Trial data is regulatory evidence. Systems that lose data or can't prove provenance kill drug approval. Consult Saksham has built trial data systems with redundancy, encryption, and cryptographic proof of integrity.
Three to four weeks. Principal-led platform, data, and delivery review with a written plan.
Monthly retainer at the right cadence for the stage. Weekly call, hire panels, board prep.
Build, buy, partner across the Pharma & Life Sciences-relevant use cases. Governance and economics included.
Ten to fifteen business days. Investor memo, 100-day plan, direct readout.
Three active trials generating 500K patient records. The data management platform was a patchwork of vendor tools and manual processes. Every regulatory submission required weeks of data reconciliation. One data integrity finding could delay approval by months.
Saksham designed a unified clinical data platform with FDA 21 CFR Part 11 compliance built into the architecture. Data reconciliation that previously took weeks became automated. Trial duration reduced 23% because data was available for analysis in real time rather than in batches.
The first conversation is thirty minutes. By the end of it, the shape of the engagement is clear.