• EU Clinical Trial Regulation 536/2014: Real-World Learnings, Best Practices For Successful Document Submissions In An Evolving System

    Clinical Research News | The European Union Clinical Trial Regulation 536/2014 went live on January 31, 2022, with the purpose of harmonizing clinical trial document submission processes within the European Union member states and improving transparency to the public.

    Nov 10, 2023

  • Seeing the Bigger Picture for AI Application With Michael Ibara

    Clinical Research News | Though increasing in popularity, the application of AI is not as widespread as some may think. In the case of clinical trials, AI is seldom used to help with organizing data, managing studies, and processing information.

    Nov 8, 2023

  • Innovation Opportunities in Vendor Selection and Partnerships

    Clinical Research News | In clinical research, outsourcing is more of a partnership than it is just handing off work to other teams. The stakes are high, and the success of outsourcing relationships directly impact the success or failure of a pharmaceutical program.

    Nov 7, 2023

  • Decentralized Clinical Trials: Navigating The Regulatory Landscape For Efficient And Patient-Centric Research

    Clinical Research News | The global decentralized clinical trials (DCTs) market is expected to see significant growth in the coming years. In 2021, the market was valued at $8.8 billion. And in 2026, the market is projected to reach $14.2 billion. Several key factors are fueling this transformation, including the impact of COVID-19 lockdowns and restrictions, the increasing demand for faster and more cost-effective drug trials, the growing preference of patients to participate in clinical trials remotely, and the availability of electronic patient-reported outcomes (ePRO).

    Nov 3, 2023

  • Evaluating Risk in the Era of Decentralized Clinical Trials

    Clinical Research News | Since the pandemic, decentralized trials have claimed the lion’s share of conversation around trial design and participant engagement. When it comes to risk-based quality management, decentralized trials can also mean decentralized control. More options for patients means more opportunity for risk.

    Nov 1, 2023

  • Sexy Science, Clinical Ops as a Business, Data Custodians

    Clinical Research News | Bravard’s opening keynote at SCOPE Europe challenged the community to view clinical ops as a growth driver for business and inspired them to fight the good fight.

    Oct 31, 2023