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Case study

Supporting a regulatory submission proactively

Managing large global trials involving tens of thousands of patients is only possible with the help of automated systems such as Almac’s IXRS®. Yet, even with the use of software to randomise patients and manage kit assignments, anomalies can crop up in the way that sites deal with patients and kits.

From time to time, studies require manual intervention in the system records—a process that can jeopardise data quality if it is not handled and recorded properly. To ensure that no such anomalies affected the integrity of the data submitted to regulators on two particularly large trials, Almac Clinical Technologies proactively audited and reconciled the records of all manual overrides in the system.

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Almac Clinical Technologies

Almac Clinical Technologies is here to help the biopharmaceutical industry bring new therapies to those in need by empowering clinical trial sponsors to proactively manage sites, patients, and clinical trial supplies through our industry-leading Interactive Response Technology (IRT) and expert consultancy.

Almac Clinical Technologies is uniquely positioned to unlock new efficiencies in the clinical supply chain and to help achieve greater predictability in your projects and programs.

Our professionals are dedicated to delivering high-quality Interactive Response Technology (IRT) solutions, dependable professional services, and reliable customer service. Our expertise, energy, and commitment have earned us a reputation as a trusted ally in the drug development process.

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