The cost and complexity of clinical development mandates the application of rigourous planning processes.  Being clear about the objectives of the program, ensuring these are agreed and understood, and tracking and reporting of progress towards those objectives are fundamental elements. Prospective planning for decision points, seeking efficiencies, and understanding areas of  regulatory risk add value to programs and can reduce the total amount of time a program takes.

 

Medicines Development Limited has expertise in industry-standard new chemical/biological entity development, clinical research planning and management. We will either supplement the skills of your existing team, or step in to act as the hub of your development program. Our experience has been gained in large and small pharmaceutical and biotechnology and academic settings in the United States, Europe and Australia. Our experience encompasses the first steps in the development through the New Drug Application/Marketing Authorisation Approval process and into Phase IIIb/IV clinical research.  

 

We work with you to deconstruct your development program to understand the components (scientific, commercial, preclinical, clinical, regulatory) and scope, and then reassemble these into an integrated development plan. We then apply thorough project planning and comprehensive reporting and communication mechanisms to ensure that your development process is well managed, effective and transparent.  We help you select and work with Contract Research Organisations in order to optimise your expenditure.