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    Keys to Successful Cell & Gene Launches


    Navigating the evolving and complex healthcare data, policy, and regulatory requirements for cell and gene therapies presents new challenges to patient access. Supporting indications across lymphoma, leukemia, hemophilia and more, we have a proven strategy to ensure we remove the barriers patients face when seeking treatment.

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    Clinical Trial Gone Right: How We Helped Our Client Regain Control of Their Active Phase III Trial


    A large biopharmaceutical sponsor trusted UBC to transition an active study from their existing CRO to improve trial site experience and engagement as well as data quality. UBC supported the needs of the sites and patients in order to successfully transition the trial and meet submission deadlines.

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    Decentralized Research Playbook


    Study designs are rapidly transforming. More comprehensive solutions are required to collect critical evidence beyond the walls of the traditional study setting. So how do you plan, prioritize, and educate internal partners as you help your company enter the world of decentralized trials? Dive into UBC's playbook to uncover the key considerations today.

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    Enriching Registries with Real World Evidence


    UBC’s Dr. Annette Stemhagen, Chief Scientific Officer and Brett Huselton, SVP Commercial Strategy share three key ingredients to successful evidence generation strategies, allowing sponsors to obtain a more holistic picture of the patient, beyond the focus of the protocol itself.

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    Is Your Organization Pharmacovigilance Ready?


    The right strategy to continually evaluate product safety in your clinical trials, through regulatory review and entering the post-marketing setting, is complex. Are you ready?

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    5 Steps to Mastering PV Signal Detection and Management


    The ability to categorize and assess signals that are received in your pharmacovigilance program is critical to ensure patient safety and adherence to global regulatory requirements. Have you mastered the five steps?

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    How to Select a CRO


    Before the selection of important safety, clinical development and late stage vendors, it’s paramount to understand what is the best match for your company. This webinar will help you understand how consultants can improve the overall experience of working with a CRO and discuss how consultants can help problem solve your companies challenges and the importance of the appropriate vendor selection.

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    Clinical Trial and Technology Experts: Why the Future of Research is Decentralized


    Decentralized research is the future of clinical development. But how do you ensure you have a cohesive and effective research program? Aaron Berger, Executive Director, North American Late Stage Operations, Justin Wilson, Director of Software Technology and John Reites, CEO, THREAD share how.

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    REMS: An Overview


    Guiding manufacturers in meeting FDA requirements to ensure the benefits of a drug or biologic product outweigh its risks.

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    Expedited Pharmacovigilance Migration and Global Regulatory Reporting


    UBC was selected by a mid-size pharmaceutical company to provide pharmacovigilance (PV) services of more than 11,000 existing cases for six oncology products. The program resulted in no critical findings during an FDA and Medicines and Healthcare Products Regulatory Agency (MHRA) audit.

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    7 Essential Questions to Shape Your Virtual & Decentralized Study


    Jersino Jean-Mary, Executive Director, European Late Stage Operations, and Aaron Berger, Executive Director, North American Late Stage Operations, shared their thoughts on how the pandemic is impacting clinical trials and post-approval research, and ways that the industry is working together to get patients the access they vitally need to novel therapies.

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    A Safety Physician’s Predictions for How AI Will Streamline Pharmacovigilance Processes for the Future


    Dr. Alexandra Thoenes, MD and Senior Project Safety Physician, discusses the guidelines the WHO released on AI in healthcare and how that impacts using AI in pharmacovigilance.

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    We look forward to helping you address the important challenges that surround bringing your product to market.