Our substantial experience of developing and conducting adaptive protocols for Phase I and II trials enables us to maximise the return on our sponsors’ studies whilst guaranteeing the safety of our participants.
Adding value by gathering more and highly relevant data. We only collect and analyse essential data to meet the trial objectives within a limited budget.
We limit assessments and participant exposure to what is relevant and essential. Tailoring our adaptive limits and control mechanisms for each protocol to manage potential risks.
Umbrella protocols to maximise efficiency. We integrate ethnic comparison elements, intensive cardiac assessments, and other biomarkers into a combined umbrella protocol - avoiding potential risks in further drug development.
Using adaptive design to support rational “no-go” or “where to go next” decisions, an entire early phase programme from First-In-Human to Proof of Concept can be performed in one trial protocol, in one trial centre.
We adapt the trial design whilst maintaining the validity of the data and integrity of the trial.
We have an excellent track record for starting studies on time and effectively managing ethics and regulatory submissions.
Fast and efficient adaptive protocol development using a transparent and systematic approach.