Leveraging our extensive therapeutic, scientific, and regulatory expertise, we’ve introduced Accelerant™, an experience-driven dynamic planning and operational model, to enhance clinical trial deliverables.
By embedding this model in every trial managed by Accelsiors, we ensure the seamless integration of quality, data access, visualization through our advanced clinical technology, and the acceleration of study progress.
All the while, we keep our focus firmly on patient perspectives and cost-effectiveness, for a truly engaging and efficient clinical trial experience.
As the only ones with firsthand experience of living with the disease day to day, patients bring irreplaceable perspectives to drug development that cannot be provided by any of the scientific, regulatory, or clinical experts. During the whole lifecycle of medicine development, practical consideration and inclusion of the patient's perspective in clinical trials will increase the quality of the development program. This can help to understand better/design the following areas:
However, we understand that, at the moment, strategies and methodologies to obtain patients' perspectives on a clinical trial are highly non-standardized. Significant regulatory authorities like ICH and FDA are developing guidelines to standardize the collection of patient feedback in clinical trial design. Therefore, we developed our internal methodology that considers the following essential features:
Also, information about patients' perspectives is gathered through different publicly available sources, including, e.g. Patient-Focused Drug Development (PFDD) Public Meetings-initiative facilitated by FDA focused on how to understand better patient's view of the most significant symptoms of their disease and treatments.