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    Full Visibility For Study Teams And Control Over Consent

    Enhancing patient comprehension and giving study teams full visibility and control over consent throughout your trial.

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    PHCbi LabSVIFT® IoT Lab Management Solution

    PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model

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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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    Sikich Clinical Trial Management

    Shorten start-up times for your clinical research studies by eliminating manual spreadsheets once and for all. SuiteSuccess for contract and clinical research organizations (CROs) allows you to unify clinical applications to improve visibility and oversight across the organization in one software platform. Now you can automate inefficient manual processes, from bid to bill, and deliver more quickly and more profitably than your competitors.

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    On-Line Glucose And Lactate Analyzer

    Get faster process insights and dynamic control of substrate feeding without the loss of bioreactor or fermenter volume.

    Keep Your Cells Happy

    Fluctuations in glucose levels, associated with infrequent measurements and bolus feeding, may cause metabolic deregulation and undesirable process deviations.

    That’s where MAVEN comes in. It has your back, automatically monitoring and controlling glucose and lactate concentrations, helping you realize your PAT strategy.

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