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Maintaining compliance with new ICH monitoring guidelines

In late 2016, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued revised guidance (E6, R2) concerning sponsors’ responsibilities with respect to trial oversight.

The guidance makes it clear that sponsors must ensure oversight of any trial-related duties carried out on their behalf, and that includes the treatment of source data.

It must be “attributable, legible, contemporaneous, original, accurate and complete1,” with changes traceable.

This revised guidance has prompted the need for sponsors to be empowered to create their own audit trail reports within Interactive Response Technology(IRT) systems.

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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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