Are you ready for the new FDA data standards?

Meet the new requirements by applying technology built to meet FDA regulations

New FDA regulatory requirements can make it challenging to present biomarker data in a CDISC-compliant format. Fortunately, new technology simplifies the processing and mapping of specialty lab data—while simultaneously reducing trial time and cost by orders of magnitude. Our new Precision Brief, Biomarker Data Management in Clinical Trials: Addressing the Challenges of the New Regulatory Landscape, explains how.

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.