Easy to understand, step-by-step guidance protocols for your biologically-active compound starting with an overall strategy, a comprehensive clinical protocol design outline, a statistical analysis perspective, and a complete guide to regulatory submission.
Effective drug validation strategies use biomarker discovery and analysis during the many steps involved in the formulation of an effective therapy. From the original 'go/no go' decisions of preliminary targeting studies, to selecting best responders for bioactivity and bioavailability studies, and finally to the ability to monitor and finely tune individual therapies biomarker development holds the promise of helping professionals make faster decisions leading to shorter drug submission turnover times.
From process development to data analysis and clinical documentation, we provide assistance to all phases of drug development and therapeutic validation. Examine a recently completed study here When therapy is hampered by hidden phenotypes it becomes difficult to validate a susscessful outcome in the absence of appropriate biomarkers. Examine our strategy for biomarker development