ISC/IDMC Coordination

Independent statistical centre (ISC) and independent data monitoring committee (IDMC) coordination

For trials with one or more interim analyses, Cardinal Systems 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.

Activities managed within the independent statistical centre include the writing/review of statistical sections of the protocol, the drafting 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.

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Partners & Working Groups

Cardinal Systems works in partnership with O4CP for the Loulla & Philla FP7 project.

Cardinal Systems participates actively in working groups, such as DIA, PSI, CDISC, SFdS and EFSPI.

Cardinal Systems has been supporting France Biotech since 2001, and works closely with governmental institutions implicated in the valorisation of innovation, such as Oseo, Pactepme and Medicen.

Partners