Our Project Management Teams consist of senior project managers with at least a 5-year track record in the Life Sciences industry with many having PhD-level expertise in specific drug development areas. Each project manager has proven experience in the set-up and management of drug development programs. Our teams understand that development programs need to be executed with a great eye to attention, anticipating changes and risks while maintaining the highest quality level. Our people also have excellent communication skills and do realize that increasing visibility on project implementation and project management tasks facilitates integration into sponsor teams effectively and efficiently.
A typical drug development program starts with a thorough review of the available data. This is followed by the design of a ‘roadmap’ or drug development plan that outlines the essential minimal package required (bio)chemical and pharmaceutical, nonclinical and clinical studies, including possible biomarker development, drug formulation requirements, regulatory requirements, quality assurance, timelines and the risks and costs that are associated with the development of the product up to a certain milestone. Optionally, a modeling and simulation approach may also be addressed in the drug development plan.
CMC, Non-Clinical and Clinical Phase I-IV Study Programs
Strategic project management is the key to success. As studies become more and more complex, the importance of effective project management has come to the fore. We have implemented a system of Executive Oversight where a senior clinical representative oversees the progress of studies being conducted. Our clients benefit greatly from this process as they have the peace of mind knowing that their project is being conducted with the highest standards of working practice while an experienced clinical operations team are driving activities forward.
Our project management team adheres to the highest standards of operational excellence and established industry best practices’ to ensure high quality and on-time results. We manage our studies proactively, informing our clients of any issues that may arise well in advance. With SOPs designed to ensure smooth communication, collaboration and project ownership, you can see why our clients come back to us for extra services and repeat business.
When You Need Us
Our teams have worked across international timelines and reporting systems. We ensure that we are there for our clients for all critical events, giving updates and attending important meetings and teleconferences. Our IT systems back up our dedicated processes so that the sponsor has all the relevant information to hand when needed.