Adaptive Phase I & II Trials

At Richmond Pharmacology, we prioritise adding value by gathering extensive and highly relevant data within a limited budget. Our focus is on collecting and analysing essential data that directly aligns with the trial objectives.

To ensure efficiency and participant safety, we carefully limit assessments and exposure to only what is necessary and essential for the study.

By tailoring our adaptive limits and implementing robust control mechanisms for each protocol, we effectively manage potential risks and optimise the overall trial process.

Maximising efficiency is at the core of our approach. We employ umbrella protocols that integrate various elements such as ethnic comparison, intensive cardiac assessments, and other biomarkers into a combined framework. This approach not only streamlines the data collection process but also mitigates potential risks associated with subsequent stages of drug development.

By implementing umbrella protocols, we can leverage the data collected across multiple aspects of the study, eliminating redundancy and reducing overall costs. This integrated approach allows us to efficiently assess different parameters and gather comprehensive data while maintaining participant safety as our top priority.

The inclusion of ethnic comparison elements in our umbrella protocols ensures that the trial results can be generalised across diverse populations, providing valuable insights into the safety of the investigational treatments for different ethnic groups.

Additionally, our focus on intensive cardiac assessments and other relevant biomarkers within the umbrella protocol allows for a thorough evaluation of potential cardiovascular risks associated with the investigational drug. This comprehensive approach not only enhances patient safety but also provides valuable data for informed decision making during subsequent stages of drug development.