DHT.health’s Post

LORENZ Converge is a worldwide user conference covering regulatory requirements and processes, health authority updates, and changes and innovations in the regulatory IT affairs landscape. fme's Ian Crone and Tomi Žalec will be there this year to meet and share with industry leaders best strategies for migrating and maintaining data and document integrity in a quickly changing regulatory environment. Attending? Let's get connected and meet! #LorenzConverge

Last week DIA's Journal, Therapeutic Innovation & Regulatory Science (TIRS) published a great article by George Wu, Jeremy Wildfire, and colleagues that can help you learn more about how a new free, flexible, and reliable open-source software package can help improve the efficiency and quality of #clinicaltrials through efficient risk-based monitoring (RBM). https://lnkd.in/eJWPkmux Springer Nature Group #clinicalresearch #clinicaltrials #clinicaltrialmanagement #riskbasedmonitoring

Mechanism of Action Mini Reviews demystify these complex agents and modalities, from mechanism to development and regulatory journey to clinical impact - Submit your mini review for publication in #CTSjournal: https://bit.ly/3ZgLR6X

Ensure trust and avoid penalties in clinical trial disclosure. Master quality and compliance with article 4 of our maturity model series: https://ow.ly/Bokn50TLCAZ. 🌟Free Maturity Model Assessment🌟 Get exclusive access to measure current practices and recommendations for improvements in this area, with our maturity model assessment: https://ow.ly/VVNt50TLCB0.

📣 We are so excited to share with you our latest article talking about the development and validation of the Joint Action Plan, the main outcome of the project. In a month-long robust validation process, the JAP was supported by more than 50 participants from different sectors of healthcare representing the quadruple helix: Industry, academia, civil society (including patient and healthcare professional associations) and government. Given their expertise and central role in the industry, their insights were critical to ensure the effectiveness and relevance of the JAP. You can read more about the validation process below ⬇⬇⬇

Quality and compliance are vital in clinical trial disclosure. A proactive approach safeguards your organization's reputation and fosters trust with stakeholders. NOTE: the article links to a self-assessment worksheet that may be helpful.

View this short webinar to learn how CROs can tap into best practices for mitigating risk & addressing specific clinical supply challenges commonly associated with adaptive, decentralized, platform & other complex trial designs. https://ow.ly/ZCbL50THVwt

View this short webinar to learn how CROs can tap into best practices for mitigating risk & addressing specific clinical supply challenges commonly associated with adaptive, decentralized, platform & other complex trial designs. https://ow.ly/ZCbL50THVwt

Earlier this year, the team at Emergen Research put together a comprehensive look at the state of the Process Analytical Technology (PAT) industry. They project that the sector is going to become increasingly important as quality standards rise and will grow by more than 12% per year between now and 2032. If you want to uncover the details for yourself, you can access it here: https://lnkd.in/dAKYJkqS #PAT #ProcessControl #QualityControl

Clinical trials are becoming more complex. In this HIT Consultant Media article, Kevin Landells describes why IRT support for predictive supply management, risk-based monitoring, and data integration is critical to today’s trials. Learn more: https://bit.ly/4df6uEO #ClinicalTrials #PatientCentricity #LifeSciences