Protocol Development

IMD develops full protocols that are easy to follow to ensure focus on important data and compliance during study execution. IMD considers input and review by investigational study sites and all study exeution functions critical to smooth data colelction. We work in close collaboration with the sponsor to ensure all needs are met.

Trial Design

Careful medical, scientific and statistical evaluation (by experienced statisticians), and when appropriate simulations are always a critical part of trial design provided by IMD. This ensures efficient trial designs that bring forward conclusive data.

Adaptive Features for Efficiency

Depending on the specific situation nontraditional methodologies such as adaptive allocation, other forms of adaptive designs such as adaptive sample size or sequential designs may be developed. For development trials that require negotiation with regulatory agencies, performance characteristics of such designs are prepared and negotiated to ensure regulatory success.

The Range of Data Sources

For medical affairs IMD has experience with the different data gathering techniques ranging from clinical pharmacology trials through naturalistic trials or even retrospective analysis of existing databases thus ensuring optimal design for a given situation.