|
| |
| The purpose of a Data Safety Committee
(DSC) is to provide appropriate
oversight and monitoring by an independent
group, to better ensure the safety of study
participants and the validity and integrity of
the study data. Although a DSC is not required
for all studies according to government
regulations, many institutions now require such
a review committee for all studies. At Veeda
Oncology, we recognize the importance of the DSC
and are able to assist sponsors in DSC
activities by: |
| |
- Drafting a DSC charter to describe the
structure and operation of the committee
- Identifying appropriate committee members
who have the relevant clinical and statistical
expertise
- Analyzing data and preparing reports
- Adjudicating endpoints, if required
- Organizing the meetings
- Draft agendas
- Schedule meetings
- Distribute agendas, minutes and other committee documents
- Attend meetings as an independent party and generate minutes
|
| Veeda Oncology is experienced in DSC
oversight and we can also coordinate monitoring
and data management efforts. In this way,
DSC is assured of having timely
data for effective decision-making. |
