Clinical Trial And Programme Design

Clinical programme design involves balancing objectives and constraints that represent a mix of clinical, pharmacokinetic, toxicology, regulatory, ethical and budget factors. Emphron provides statistical design, modelling and simulation services to achieve that balance. Our services include programme and protocol development and review, SAP development and review, integrated analysis of multiple clinical trials to inform dose selection and other design decisions, and programme risk assessment

Much of Emphron's clinical research services are associated with risk management for the clinical programme. A single phase III trial can cost tens of millions of dollars and can represent a single point of failure for the business. Rational investment decisions require a good understanding of the probability of trial and programme success.

Phase IIb and Phase III trials usually require a complex test hierarchy, integrating multiple comparisons over multiple endpoints. There are frequently no simple analytical power calculations for the probability of trial success; this is especially the case with adaptive trial designs.

Emphron has developed a clinical programme simulation infrastructure which makes use of massively parallel computing. There are no constraints on design and analysis methods or on the complexity of decision processes; the infrastructure can accommodate parallel group, cross over and adaptive designs, and allows analysis of multiple simulated endpoints using linear and non linear mixed models, generalised linear mixed models, censored survival techniques or any technique in regular use in clinical research. We are also able to conduct large scale simulation analysis of Bayesian approaches.

Large and complex risk assessments that previously required weeks can be completed in a few hours.

The same infrastructure can be used to perform phase III dose selection using integrated pharmaco dynamic modelling and analysis across the entire Phase II programme.

The ready availability of super computing resource allows an agile and highly interactive approach to programme optimisation; new ideas and constraints can be investigated thoroughly, as they arise. The Emphron infrastructure supports rigorous risk management in a thoroughly commercial time frame. It provides an order of magnitude improvement over conventional simulation approaches.

Emphron has experience across a range of clinical areas with especially deep expertise in medical devices, respiratory trials and diagnostics.

Emphron's data analysis and trial design experience cover everything from molecules to ecosystems.