INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation

  In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.

• 6 Decades Of Impact: DIA’s Global Journey

  By embracing its foundational pillars, learn how DIA continues to address ongoing challenges in drug information and healthcare as it enters its seventh decade in the industry.

• Key Transition Timelines For Clinical Trials Regulation (CTR)

  As deadlines loom for transitioning ongoing clinical trials in the EU to the Clinical Trials Regulation (CTR), understanding key timelines and dates becomes critical.

• The Synergistic Role Of Drug Safety In Clinical Trial Operations

  Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

• Considerations For Plain Language Summaries

  4/22/2024

  Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.

• Reporting To The IRB: Investigator Noncompliance

  4/19/2024

  Reporting noncompliance concerns is crucial to protect research participants. By promptly reporting noncompliance, researchers can ensure ethical research conduct and protect the rights and welfare of participants.

• Understanding FDA’s 2024 Draft Guidance On DMCs

  4/19/2024

  By integrating independent Data Monitoring Committees into trial management processes, learn how sponsors can enhance trust, integrity, and the success of their clinical trials.

• The Value Of Continuity: Program-Level DSMBs

  4/19/2024

  Discover the strategic benefits of deploying consistent DSMB members across therapeutic programs, highlighting the pivotal role of program-level supervision in safeguarding the safety and effectiveness of novel treatments.

• When Quickbooks Leaves Your Life Sciences Venture Struggling

  4/18/2024

  Is QuickBooks keeping pace with your life sciences venture? Learn the signs it's time to move beyond and adopt tailored solutions for growth, compliance, collaboration, security, and automation.

REGULATORY MULTIMEDIA

• The Synergistic Role Of Drug Safety In Clinical Trial Operations

  Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

• Success Planning For An Original NDA/BLA Submission

  Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).

• Seeking Clarity With DCT Guidance

  Merissa Govender, Global Innovation Leader at Sanofi, Lindsay Kehoe, Senior Project Manager at Clinical Trials Transformation Initiative (CTTI), and Aneta Woroniecka-Osio, DCT Strategy Development Lead at Bayer join folks at Clinical Leader Live for the session Last Year’s DCT Is Today’s Clinical Trial. In this snippet, Kehoe covers topics such as the ICH E6(R3) guidance and its annex for DCTs, the use of RWD, and connecting with regulators.

• Some Common DCT Concerns Addressed

  Merissa Govender, holding the position of Global Innovation Leader at Sanofi, Lindsay Kehoe, who serves as Senior Project Manager at the Clinical Trials Transformation Initiative (CTTI), and Aneta Woroniecka-Osio, the DCT Strategy Development Lead at Bayer, converge for a thought-provoking session on Clinical Leader Live titled Last Year’s DCT Is Today’s Clinical Trial. As noted in the full discussion, oversight of remote sites or home health workers is a concern with DCTs. In this segment, Govender talks about the delegation of duties log and safety reporting with DCTs.

• Advancing Development Of New Oncology Therapies

  Learn how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.

• psiXchange: Intelligent, Automated Safety Reporting

  Say goodbye to manual burdens and embrace efficiency by fully automating your safety reporting. This will significantly cut down on effort and costs, all while enhancing compliance standards.

• Improving Safety Reporting Speed And Accuracy With Automation And Embedded Intelligence

  Watch this exploration of real-world case studies of companies utilizing intelligent process automation and embedded, regularly updated safety reporting regulatory intelligence of psiXchange software.

• Avance Clinical Expands Pharmaceutical Safety Services With Oracle Argus

  Find out what happened after this contract research organization turned to Oracle Argus for compliant clinical trial management.

• Managing A Continually Evolving Disclosure Landscape

  Compliance is more important than ever. Keep up with how regions are enforcing disclosure requirements by learning how to adjust compliance strategies accordingly.

• Exploring The Interactions Between Validation, Technology Transfer

  Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.