We manage BE trials in patient populations with disease-specific design, regulatory alignment, and robust PK/PD analysis.
We specialize in rescuing underperforming studies — from re-strategizing operations to reactivating sites and cleaning up data.
We provide strategic statistical planning, analysis, and regulatory-compliant outputs — helping you make data-driven decisions.
We offer clinical and post-marketing PV support — from SAE handling to DSURs, signal detection, and inspection readiness.
Our DCT models combine virtual visits, ePROs, wearables, and home care — expanding reach, reducing site burden, and enhancing flexibility.
We design RWE studies that generate insights from EHRs, registries, and patient data — supporting regulatory, clinical, and market goals.
We ensure clean, consistent, and compliant datasets with global standards (CDISC, GCP, 21 CFR Part 11) and cutting-edge EDC platforms.
We offer end-to-end regulatory support — from early strategy and submissions to post-approval maintenance — across regions and product types.
We embed QA at every trial stage — from SOPs to site audits — ensuring risk mitigation, inspection readiness, and global compliance.
We turn complex data into clear, regulatory-ready documents. From protocols to publications — our writing brings clarity to your science.
We plan, manage, and monitor your trials from start to finish — ensuring fast start-up, patient-focused execution, and quality delivery. Choose full-service or functional support.