Independent Statistical Centre (ISC) and Independent Data Monitoring Committees (IDMC)
For trials with one or more interim analyses, Venn Life Sciences provides an independent statistical centre (ISC) service and medical, methodology and statistical experts to coordinate and/or participate (as voting or non-voting members) in independent data monitoring committees (IDMC).
The primary role of the ISC is to perform interim analyses of the clinical trial data and prepare reports for the IDMC, while preserving the confidentiality of unblinded interim results and the integrity of the study.
Activities managed within the independent statistical centre include the writing/review of statistical sections of the protocol, the writing of the IDMC charter (including written operating procedures to describe data flow and document the firewalls in place to preserve data integrity and avoid operational bias), the review of data collection instruments (e.g. case report forms), statistical analysis plan development (including specific interim analysis plans), participation in blind reviews and the writing of blinded/semi-blinded or unblinded interim reports for closed IDMC sessions and final analysis reports.
An independent IVRS/IWRS service can also be provided with ISC and/or IDMC services.