Interim Analyses – DMC

Experts in Data Monitoring Committee Services

A Data Monitoring Committee (DMC) is a group of clinicians and biostatisticians appointed by the study Sponsor who provide independent assessment of the safety, scientific validity and integrity of a clinical trial while it is ongoing.

DMCs are strongly recommended by Regulatory Authorities in all trials that assess new interventions but also trials that can have safety issues and/or double blind/double mask treatment assignment. The main objective of these DMCs is to protect the patient.

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Data Monitoring Committees Comprehensive Services

DMC member contracting	Programming
Presentation of results at open and closed meeting	Data quality review
DMC organization including logistics	Blinded or unblinded analyses
Charter design and/or review	TFLs for interim analyses
Safety and interim efficacy analyses	Reports
Design of templates	Presentation of results at open and closed meeting
Data Transfers

Deep Data Monitoring Committee (DMC) Experience

Almustat dedicates a portion of its biostatistics team to IDMC support: (experienced biostatisticians serving as independent statisticians, experts serving as DMC Members).

Our biostatisticians are true experts, delivering only what the committee members need in a succinct, complete and reproducible fashion.

Our years of experience supporting multiple DMCs have positioned us to develop a clear, precise report format that enables swift and thorough review of reports by DMC members.

Thanks to their extensive experience in DMCs, IDDI biostatisticians are highly knowledgeable about relevant statistical methods associated with interim analyses, including sequential designs, group-sequential designs, adaptive designs, conditional power and futility calculations, and sample-size adjustments.

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