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Recent Posts

  • Data Minimization is a Key Theme in Clinical Trials
  • AI + Data Management: Hype, Help, or Both?
  • Global Trial Challenge: The Logistics of International Trials
  • Reflections from SCOPE 2026: Balancing Patient Centricity with High-Tech…
  • Why Beacon Academy Matters to Me & PROMETRIKA’s Support of My…
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  • July 31 2022 Jake Adler

    Optimizing TLF Generation: Titles and Footnotes, Applying a New Idea to a Basic Approach

    PROMETRIKA’s statistical programming team is developing methods to enhance the efficiency and maintain high quality of table development while managing changes in the data and the requirements as table programming is in progress.

    • Statistical Programming
    • TLF
    • Clinical Study Report
    • Table Shells
    Continue Reading
  • June 30 2022 Gina Hird

    Applying Agile Methodology to Statistical Programming

    In any industry, there are various methods for approaching task deadlines to remain within the timeline. It is vital to choose a method that can accommodate challenges faced during the project and reduce time or at least help mitigate any delays. Effective task management is the key to maintaining the project budget and addressing other challenges.

    • CRO
    • CDISC
    • CDISC SDTM
    • Agile
    • Statistical Programming
    Continue Reading
  • May 31 2022 Amanda Rychel, PhD

    Enhancing Inclusion in Clinical Trials With a Patient Centered Approach

    Drug development and clinical research methods evolve continuously through establishment of new regulations and through adaptations to changes in treatment accessibility, technology, evolving knowledge in biology, and appearance of new diseases. 

    Patient-centric trials, in which the perspective of the patient is considered in study design and performance, is one such new approach in clinical research that primarily focuses on reducing patient burden. 

    • Clinical Trials
    • Patient-centric
    • FDA
    • Recruitment
    • Decentralized Clinical Trials
    Continue Reading
  • April 30 2022 Aileen Ryan, MS

    The Investigator Responsibilities in IND Safety Reporting

    An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

    • Drug Safety
    • Full-service CRO
    • Pharmacovigilance
    • IND
    • SAE
    Continue Reading
  • March 31 2022 Aileen Ryan, MS

    The Sponsor’s Responsibilities in IND Safety Reporting

    An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

    • Drug Safety
    • Full-service CRO
    • Pharmacovigilance
    • IND
    • SAE
    Continue Reading
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Recent Posts

  • Data Minimization is a Key Theme in Clinical Trials
  • AI + Data Management: Hype, Help, or Both?
  • Global Trial Challenge: The Logistics of International Trials
  • Reflections from SCOPE 2026: Balancing Patient Centricity with High-Tech…
  • Why Beacon Academy Matters to Me & PROMETRIKA’s Support of My…
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