Our substantial experience of developing and conducting adaptive protocols enables us to maximise the return on our sponsors’ trials whilst guaranteeing the safety of our participants
- Collection and analysis of only relevant and essential data to meet objectives within a limited budget
- Adding value by gathering more and highly relevant data
- Fast and efficient adaptive protocol development using a transparent and systematic three-step approach
- Streamlined study conduct from set up through clinic to final clinical study report
- Immediate implementation of adaptive changes as long as they are within the authorised adaptive scope
- Efficient scheduling of adaptive ‘umbrella’ protocols using essential data outputs for early decision making
- Tailor-made study specific adaptive limits and control mechanisms to manage potential risks
- Limitation of assessments and participant exposure to what is relevant and essential
From First-In-Human to Proof of Concept
We maximise return on our sponsors’ trials. 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 add value by integrating ethnic comparison elements, intensive cardiac assessments, and other biomarkers into a combined umbrella protocol. This means potential risks in further drug development can be avoided.
Systematic and logical protocols
Our three-step approach allows us to adapt and modify the trial design without undermining the validity of the data and integrity of the trial. We achieve this by continuously learning from the data, scrutinising any adaptive features, their boundaries and study control mechanisms and ensuring complete transparency.
Competent and Fast Decisions
We guarantee rapid progression of your trial. Our specialised medical and data management teams collaborate with our multidisciplinary partners, communicating closely with sponsors for competent, fast decision making. We review emerging quality-controlled data and use this to modify the study within pre-approved limits, whilst safeguarding participants and ensuring the study objectives are met.
We have an excellent track record for starting studies on time and effectively managing ethics and regulatory submissions. Our processes are tailored to ensure a minimum of queries and rejection letters. This enables us to run entire Phase I programmes, including first evaluation of efficacy in groups of patients as part of one protocol and following a single regulatory and ethical approval.
Whilst progressing through the various parts of a combined trial, there is no need to share interim data with the competent authority or ethics committee, unless there is intention to go beyond pre-defined and approved adaptive boundaries.