Transactional Content Management

PRODUCTS

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    Getting Novel Therapies To Patients Everywhere

    From regulatory pathway selection to patient recruitment challenges to navigating the volume of data to collect and clean — a rare disease therapy requires an extraordinary amount of coordination.

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    NDA Submissions 505(b)(1) Or 505(b)(2)

    There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

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    Electronic Data Capture (EDC) System: Leverage Flexibility And Speed

    Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.

    They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.

    Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.

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    eTMF: Promising Accessibility, Compliance, And More

    Our model combines the depth and experience level of our people with effective tools and processes already in place that are designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

  • AST innovation
    A User-Friendly Solution For Fill-Finish Professionals

    When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.

    Does an isolator need to be ergonomically unfriendly to clean?

    Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).

    Does routine maintenance have to be time-consuming and laborious?

    Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?

WHITE PAPERS AND CASE STUDIES

NEWS