INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

  • The Challenges Of eCTD Implementation In Small Company And Academic Settings

    This webinar recording will give an overview of challenges and successes of implementation of eCTD in both a small biotech setting and in academia, as these areas of industry face additional challenges that most midsize and large companies may not have.

  • The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On U.S. Clinical Research

    As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

  • Botanical Medicines In Research

    Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

  • 5 Strategies For APAC Drug Submissions: Korea, China, Japan

    Korea, China, and Japan are no strangers to clinical trials in Asia. They have large patient populations and sophisticated regulatory systems and infrastructure, and each has worked to adopt the CTD or eCTD for submissions. That said, they also require the most content to be presented in-language to local regulators. So how do you manage up to five million words of critical content translation across 330 files and submit on time?

  • Why And How Global Healthcare Product Regulators Are Joining Forces

    The ICMRA is now considered a strategic cross-border leader among a select group of global medicine and device regulatory policy bodies. Read how the coalition is working across the world to help sponsors develop medical products in a more globally harmonized way moving forward.

  • Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial

    A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

  • A New Era In Dermatology: Study Design, Regulatory Strategies, And Patient Participation

    This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical elements when devising effective recruitment and retention strategies.

  • Accelerating The Recovery – Design And IRB Review Of Safety Monitoring Plans During COVID-19

    How do remote visits and remote data collection impact participant safety monitoring? This article presents ways to satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world.

  • FDA Inspections Need Not Be Stressful

    As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Global Pharmacovigilance And Safety Solutions

    As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.

  • Reduce Cost And Effort When Servicing Clinical Trials In Canada

    Contracting an in-country clinical depot helps bring costs and timelines under control.

  • DIA NOW In Focus

    Learn more about DIA NOW In Focus on Pharmacovigilance, the scope of the content offered, and how it can help you keep current and gain insights into hottest Pharmacovigilance topics from around the world.

  • TrialScope Disclosure Management Brochure

    TrialScope Clinical Trial Registry Manager (CTRM) delivers the proven solutions clinical trial sponsors need to centralize, track, register, and comply with clinical trial disclosure processes, mitigating compliance risks while giving them greater control over their own clinical trial disclosure reputation.

  • Regulatory Affairs

    As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.