 We design and implement fit-for-purpose operating flows across the study lifecycle: demand and supply planning for IMP/AMP, master data and batch governance, labeling and randomization handshakes, document and audit readiness, and near-real-time visibility for decision makers. On the tech side, we integrate SAP with trial systems (CTMS, eTMF, EDC/eCOA, IRT/RTSM), set up clean interfaces (e.g., dataloggers, depots, and ERP), and apply validation practices aligned to GxP and GAMP 5 principles.

 Trials stall on handoffs, between systems, vendors, and teams. Our purpose is to remove those bottlenecks: clear ownership, lean SOPs, stable master data, and software that mirrors reality. The result is fewer deviations, faster cycle times, and audit-proof traceability from planning to close-out.

Doctor K Consulting

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Doctor K Consulting

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