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  • TMF Survey: Major Changes To Clinical Operations
    TMF Survey: Major Changes To Clinical Operations

    Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.

  • 3 Steps For More Effective Sponsor-CRO Partnerships
    3 Steps For More Effective Sponsor-CRO Partnerships

    Clinical Operations (ClinOps) leaders increasingly outsource critical components of their trials. By one estimate, 75% of pharmaceutical and biotechnology companies are now outsourcing data management and over 70% are outsourcing site operations. As a consequence of the growth of this practice, effective collaboration between Sponsors and their CROs has never been more critical for achieving clinical trial milestones on-time and within budget.

  • The True Disruptors In Clinical Trials: Insights From Agile, Merck, BI, And EMD Serono
    The True Disruptors In Clinical Trials: Insights From Agile, Merck, BI, And EMD Serono

    Innovation is shaking up the world of clinical trials. Advancements in technology are rapidly changing the landscape of data collection and analysis, while patients and patient advocacy groups do their best to get their voices heard in the process of planning and executing trials. But while we often hear references to disruptions in clinical trials, it can often be difficult to identify exactly what is disrupting the process.

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Clinical Operations Clinical Operations

Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

Medidata CTMS™ Medidata CTMS™

Medidata CTMS™ is a centralized, enterprise clinical trial management system (CTMS) that helps effectively deploy critical resources, proactively address performance issues and streamline operational workflows. Powerful, configurable modules automate critical trial management and administration functions, including monitoring and payments.

  • Integrated EDC. Configurable integration with Medidata’s EDC system eliminates the need for engineering or technical expertise.
  • Open. Open architecture seamlessly exchanges information with other systems including Medidata EDC pre-populating data, triggering events and eliminating duplicate work.
  • Agile. Agile development methodology continually updates Medidata CTMS with regular functional enhancements, ensuring it keeps pace with your clinical research processes.
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