Healthcare

PRODUCTS

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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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    EHR To EDC Connectivity With TrialKit

    Capture EHR/EMR data in TrialKit with no integration required.

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    Software And ERP Solutions For Life Sciences

    Implement Software Solutions that Support and Enhance Your Mission

    Whether you’re heading toward clinical trials or on the path to commercialization, implement technology infrastructure that keeps pace. The last thing you need in a fast-moving industry is for your business management solutions to lag behind.

    As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. Sikich has helped over 250 Life Sciences companies grow from pre-revenue to commercialization quickly and painlessly.

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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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    The Importance Of Patient Recruitment In Clinical Trials

    Why Patient Recruitment Matters in Clinical Research

    Patient recruitment is one of the most critical aspects of a clinical trial’s success. Without an adequate and diverse participant pool, trials risk failing to generate reliable and representative data. Ensuring sufficient participation is essential for producing statistically valid results that confirm the treatment's safety and effectiveness.

    For biotech companies, especially those under tight timelines and budgets, partnering with an experienced CRO like Novotech ensures that patient recruitment efforts are both efficient and effective, enabling timely trial completion and robust data collection.

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