What we do

Our end-to-end clinical trial service includes development planning, protocol writing, feasibility studies, study planning, site evaluation and selection, IRB/EC submissions, site monitoring, trial management, regulatory affairs, pharmacovigilance, clinical data management, statistical analysis, and quality assurance.

We have expertise in other non-clinical technical areas such as toxicology, chemistry, manufacturing and controls, clinical pharmacology and regulatory affairs. This supports effective development strategies in compliance with local regulations, productive meetings with EMEA and FDA and timely approvals of CTAs and INDs.

Patient Recruitment and Assessment
Over the last 3 decades the number of PoC failed and false negative trials is increasing and the effect size between active drugs and placebo decreasing

Increasing sample sizes and investigators number has proven an expensive and inefficient solution to the high failure rate

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