Clinical Trials & Good Clinical Practices (GCP) Training

  • $279.00

    Writing Clinical Monitoring Reports: Using the Liquid Report Writing Method

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course presents design and writing techniques for “liquid report” planning and writing, using the report as a dynamic “living document” that harmonizes metrics, risk indicators, and action plans – and should be written by the time a monitor leaves the site or finishes the monitoring activity (e.g., remote monitoring).

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  • $279.00

    Source Data Review (SDR) vs. Source Data Verification (SDV) – A Site Monitoring Best Practices Update

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course will outline the best practices for designing and implementing SDV AND SDR programs, focusing on a risk-based approach.

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  • $279.00

    Root Cause Analysis for Clinical Research Professionals

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Come to this session and learn, practice and apply this science to create RCA tools specifically useful for both simple and complex clinical trials issues management.

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  • $279.00

    Risk-Based Monitoring Plan Development

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course proposes efficient and compliant options for the implementation and improvement of a risk-based approach to sponsor monitoring plans.

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  • $279.00

    Remote Monitoring of Clinical Source Data – Why Not?

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course discusses the feasibility of remote monitoring of source data in compliance with predicate rules, including HIPAA, FDA, as well as mandates outside the US.

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  • $279.00

    Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Attend this interactive webinar to receive a practical guide to implementing remote monitoring, where we will break down the revisions to ICH GCP e6 (R2) and answer some of your most pressing questions.

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  • $279.00

    The Power of Influencing – Achieving Patient-focused Outcomes to Guarantee Success

    Jill Donahue
    Teacher
    0 Available
    seats

    Join us for this 60-minute webinar with engaging speaker Jill Donahue, HBa, MAdEd, author of the award-winning mobile program EngageRx: The 3 Keys to Patient-focused Growth. Jill is passionate about helping lift pharma; helping us learn how to become trusted, valued partners to healthcare professionals.

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  • $279.00

    Building Accountability on Your Clinical Teams

    Janelle Brittain
    Teacher
    0 Available
    seats

    In this session, you’ll have the opportunity to analyze your current approach, your biggest people challenges and leave the session with specific actions you can take (or strategies you can use) with the people on your clinical team.

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  • $279.00

    Identifying and Closing the Training Gap in Clinical Research

    Laurie Halloran
    Teacher
    0 Available
    seats

    Sponsors of clinical trials – and organizations that execute clinical trials – consistently identify the need for well trained and qualified people at all levels to execute studies.  Fast-paced clinical trials and the pressures to quickly and effectively meet project milestones can be overwhelming.

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  • $1,649.00

    Course Vouchers – 10 Pack

    $1,649.00
    0 Available
    seats

    Purchase a voucher for 10 courses – redeem at any time! Save $100+ on each course.

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  • $1,495.00

    Course Voucher – 5 Pack

    $949.00
    0 Available
    seats

    Purchase a voucher for 5 courses – redeem at any time! Save $100+ on each course.

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  • $279.00

    Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success

    Joanna Gallant
    Teacher
    0 Available
    seats

    Standard operating procedures (SOPs) are a fact of life in regulated industry.  They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.

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  • $279.00

    Monitoring Medical Device / ISO 14155 GCP

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This training course focuses on the application of the standard specific to the sponsor monitoring responsibilities and activities.

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  • $279.00

    Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof Processes

    Daniel Orfe
    Teacher
    Betsy Fallen
    Teacher
    0 Available
    seats

    This session will be valuable to clinical trials and associated/related personnel responsible for archiving, storing, and organizing documents in a clinical setting.

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  • $279.00

    Change Management Plan Development for Risk-Based Clinical Studies: From Site Monitoring to Vendor Management and Beyond

    Angie Maurer
    Teacher
    0 Available
    seats

    With the recent ICH E6 changes to include Quality Management in the conduct of clinical trials, it is important for companies to understand how to implement Quality Management – which includes Risk-Based Monitoring (RBM) – into their studies. The purpose of this session is to help you develop and implement a change management strategy that eases the burden of transition.

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  • $279.00

    Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success

    Michael Pierro
    Teacher
    0 Available
    seats

    The recent changes in National Institutes of Health/Health and Human Services (NIH HHS) requirements (Final Rule) for registration of clinical trials and submission of results information will apply to all clinical trials of medicinal products (including Biologics) and device products. This webinar breaks down the final rule into a digestible, convenient format that will put you and your studies on the road to compliance.

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