Study Start-up

AUTOMATION SOLUTION FOR LIFE SCIENCES

Unify existing systems, bring data into context, automate and organize the clinical study start-up process across the globe.

The Study Start-up solution augments your existing systems such as Veeva, Medidata and Oracle, through seamless integration, helps bring data into context of process, enhances your workflow experience with automation and unifies all systems involved in the study start-up process while providing real-time transparency – a key requirement for a successful and timely site initiation.

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    Study Start-up made easy

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    One of the key challenges faced by any global Life Sciences company is keeping up with and adapting to the amount of change and variation in regulatory requirements around the world. The Study Start-up solution provides a way to automate the clinical study start-up process from end-to-end, providing rich user experience, flexible workflow and deep insight into the tasks orchestrated across the study sites globally.

    For a Life Sciences company, when a new drug is ready to be included in a clinical trial, a fairly complicated regulatory process is followed to get the study sites ready. An off-the-shelf Study Start-up solution for site initiation often contains rigid processes that don’t accommodate variations in global regulatory requirements.

    The Study Start-up solution orchestrates the internal collaboration of the regulatory process for circulating the new drug to various sites where it can be administered within the trial according to the Local Regulatory Health Authority.

    By augmenting your existing systems such as Veeva, Medidata and Oracle, through seamless integration, the solution helps bring data into context of process. It enhances your workflow experience with automation and unifies all systems involved in the study start-up process while providing real-time transparency – a key requirement for a successful and timely site initiation.

    This solution:

    • Assigns tasks for new site initiation including IMP Greenlight and site visit date
    • Collects and submits mandatory documents for each site initiation based on local country requirements
    • Digitally signed approval of documents to release the drug to the new sites

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      Key Highlights

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