gobalto videos

  1. Oracle Site Feasibility And Patient Recruitment 8/20/2024

    Empower your organizations to unify and manage clinical trial data seamlessly, streamline and automate safety case management, and generate real-world evidence from distinctive data sets.

  2. When Will Full Adherence To EU (536/2014) Be Required? 8/10/2022

    In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

  3. The Harmonization Of Trial Documentation Under EU (536/2014)? 8/10/2022

    In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

  4. What Do You Need To know About EU (536/2014)? 8/10/2022

    In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

  5. EU (536/2014): What Should You Know About Country Activation Cycle Times? 8/10/2022

    In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. See how the new regulation will streamline procedures and remove duplication of single submission.

  6. The EU (536/2014) CTIS Database Has Been Approved – What Happens Now? 8/10/2022

    In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

  7. Do Companies Implementing Decentralized Trials Have Sufficient Regulatory Guidance? 4/14/2021

    In this webinar segment, Tero Laulajainen, VP and head of global clinical science and operations for UCB, and Hassan Kadhim, global head of clinical trial business capabilities, clinical innovation, and industry collaborations at Bristol-Myers Squibb discuss the guidance issued by regulators to help drug developers that are implementing decentralized trials.

  8. How Is The Shift To Decentralized Trials Impacting Clinical Sites? 4/14/2021

    In this webinar segment, Tero Laulajainen, VP and head of global clinical science and operations for UCB, and Hassan Kadhim, global head of clinical trial business capabilities, clinical innovation, and industry collaborations at Bristol-Myers Squibb discuss how the implementation of new technologies related to decentralized trials is impacting the sites and clinics that work with multiple sponsor companies.

  9. Solving The Top 5 Challenges of Decentralized Trials 4/14/2021

    I had the opportunity to sit down with Tero Laulajainen, VP and head of global clinical science and operations for UCB, and Hassan Kadhim, global head of clinical trial business capabilities, clinical innovation, and industry collaborations at Bristol-Myers Squibb to discuss the challenges and what companies will need to do to overcome them.

  10. Tips For Ensuring Compliance In Decentralized Trials 4/14/2021

    In this webinar segment, Tero Laulajainen, VP and head of global clinical science and operations for UCB, and Hassan Kadhim, global head of clinical trial business capabilities, clinical innovation, and industry collaborations at Bristol-Myers Squibb discuss the issues with ensuring compliance when launching decentralized trials.