Our Services

At Kerevna, we combine scientific precision with operational excellence to deliver a full suite of CRO services. Our integrated capabilities support every stage of drug development, ensuring speed, compliance, and quality across global programs.

Clinical Trial Management

We oversee the full trial lifecycle—protocol creation, site feasibility, patient recruitment, monitoring, and database lock—with a relentless focus on quality and timelines. Our teams leverage centralized and remote monitoring models, adaptive designs, and AI-assisted feasibility tools to reduce costs and increase site performance.

Regulatory Affairs

Our regulatory strategists help navigate global submission complexities—from FDA and EMA engagement to IND/IDE filings and expedited designations. We act as your regulatory liaison to ensure rapid, compliant development through every phase, minimizing risk and enabling approvals.

Clinical Data Management

We deliver clean, submission-ready datasets using modern EDC platforms, integrated edit checks, and 21 CFR Part 11 compliant workflows. From CRF design to SAE reconciliation and SDTM conversion, we guarantee audit-readiness and regulatory-grade documentation.

Biostatistics & Analysis

Our statisticians plan, design, and analyze clinical trials with precision. We develop SAPs, perform interim and final analyses, support DSMBs, and produce statistical outputs including TLFs and integrated summaries. Our team ensures scientific and regulatory integrity in every study.

Clinical Operations

From site activation to patient retention and close-out, we offer full operational support. Our team drives timelines, coordinates vendor management, ensures GCP compliance, and maintains study integrity. We tailor our model for biotech and pharma clients alike.

Pharmacovigilance

Kerevna's PV team handles end-to-end safety case processing, including triage, narrative writing, SAE reporting, and DSUR/PSUR authoring. We ensure real-time safety surveillance and proactive risk management throughout clinical development and post-marketing.

Medical Writing

Our experienced medical writers craft high-quality regulatory and clinical documents. From protocols and IBs to CSRs and eCTD modules, we provide submission-ready content that aligns with FDA, EMA, and ICH standards. We also support publications and manuscripts.