PROJECT
MANAGEMENT / COORDINATION
The Project Manager / Clinical Trial Co-ordinator (PM / CTC) plays an essential
role in the timely and successful completion of a project. Therefore, a PM / CTC
at Omega Mediation shows a high level of initiative, communication skills and
experience.
PRE-STUDY PREPARATION
In the very beginning of a clinical trial, Omega Mediation can develop, assist
or review CRF drafts in order to ensure that the data record at the sites will
be efficient and strictly according to the trial protocol. This includes individualised CRFs that allow imaging and optical character reading.
REGULATORY SUPPORT, SUBMISSIONS/NOTIFICATIONS
In accordance with the GCP / ICH guidelines, the requirements of the regulatory
authorities and local laws, Omega Mediation prepares the specific documentation,
compiles and completes the appropriate files and forms for submission to
IEC / IRB
as well as submissions and notifications to regulatory authorities.
CLINICAL MONITORING
It is our understanding that for a successful conduct of a study Omega Mediation
needs to support the sponsor with an appropriately qualified and experienced
study
team that can meet the timelines for the study and delivery of high quality
data.
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