SERVICES:
Product Development Management

We offer a range of regulatory services and our philosophy is to work with you early in the development process in order to build a solid foundation leading to efficient global regulatory submission and approval.

Our services include:

•   Protocol writing for Phase I – IV clinical trials
•   Provision of project leader or project manager, to lead an individual study
     or a complete development program of studies
•   Supplier management and liaison
•   Set-up, management and membership of Data Safety Management Boards
    (DSMB)
•   Medical writing
•   Medical monitoring
•   Provision of data management and biostatistics services
•   Identification and ongoing liaison with Key Opinion Leaders and investigators
•   CRF/patient materials medical review
•   Non-interventional trial design