gobalto videos

1. 4C Pharma Harnesses CRO Expertise With A Unified Platform 3/11/2024

   A pharmacovigilance company with abilities in case processing, MICC, regulatory and medical writing turned to Oracle seeing them as the gold standard.

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. 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.

8. Is AI Improving Outcomes In Clinical Trials? 11/13/2020

   The complexity of initiating clinical studies continues to grow. The complexity is a confluence of complicated protocols, globalization, and regulatory changes, all at a time when there is intense pressure to restrain costs and shorten timelines. The key to reducing these complexities is the ability to use machine learning to gain critical operational insights, which will allow organizations to learn and adapt. The insights gained will allow organizations to transition from subjective decisions to data-driven decisions.