Case Study: Cara Therapeutics achieves greater agility and simplified data management with Veeva Systems (Vault CDMS) and Suvoda IRT

Supporting Complex Protocols with an Integrated EDC and IRT Solution

Cara Therapeutics, a clinical-stage biopharmaceutical, ran a complex Phase II trial for an antipruritic drug that required stratified randomization, enrollment caps by strata, seven-day run-in screening, and patient rescreening — all under tight timelines to move from Phase I learnings into Phase II quickly. The protocol also needed mid-study flexibility to drop treatment arms and adjust enrollment caps as patient accrual and data trends evolved.

Cara used an integrated solution combining Veeva Vault CDMS and Suvoda IRT with predefined data standards and near‑real‑time data syncing, so sites entered information once and the systems populated patient and visit data across both platforms. The integration shortened study startup, reduced manual entry and reconciliation errors, enabled fast mid-study changes with minimal change orders, and delivered predictable, reusable workflows that Cara applied to subsequent studies.

Cara Therapeutics

Catherine Munera

Head of Biometrics