Managing Clinical Investigator Site Inspections: Key Strategies for Success
By Nuno Pires (Director, GxP Strategy) and Ernesto Vera Sanchez, MD, MPH, PhD (VP, Department Head, GxP Strategy) In our previous blog, “Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection”, we explored the broader concept of inspection-readiness, emphasizing the importance of adhering to Good Clinical Practice (GCP) guidelines to ensure overall compliance […]
Paving the Way for Safer, More Effective Treatments for Children
By Jessica Roberts PhD, MSCI, Director and Head Quantitative Translational Pharmacology Developing safe and effective drugs for children has long been a challenge for drug developers. With the need to cater to a wide range of ages and sizes, pediatric drug development requires precise and innovative approaches. Our infographic highlights the transformative role of pharmacokinetic […]
Empowering Small Biotechs: Conquering Clinical Trial Challenges with Data Management Champions
By José Matamoros Luna, MSc (Senior Clinical Data Manager II) Small biotechnology companies continue to be a significant force in the drug development market comprising 77% of the active products in development by biotech today.1 Nonetheless, the rise of clinical trial costs, resource scarcity, and fierce competition, along with limited availability of financing, requires small […]
The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals
This informative webinar is aimed to be forward-looking, discuss the potential promises of emerging technological tools in expediting and radically changing submission preparation, pinpoint potential challenges and brainstorm resolutions. The current landscape of regulatory submissions is weighed down by the sheer volume of documentation required, complex guidelines and repetitive information across documents. It also involves the painstaking, cumbersome writing styles […]
Cell and Gene Therapy Clinical Trials: How to Successfully Operationalize a Trial of Prolonged Duration
Cell and Gene therapies hold revolutionary potential for treating a wide range of diseases however, operationalizing trials of such duration and complexity is a significant task. Their development demands meticulous planning and expertise across multiple disciplines. View this webinar to hear from Allucents operational A-Team as they share insights and strategies on how to successfully […]
Podcast: Artificial Intelligence, GCP Compliance, & Inspection Readiness in Clinical Trials
AI is increasingly being integrated across various industries, demonstrating its versatility and potential. In the biotech sector, it is important to consider how the use of AI might impact integral factors such as GCP compliance and inspection readiness. The incorporation of AI in the clinical trial process brings about a transformative influence on GCP compliance […]
Evolving Advisory Committee Processes: Key Updates From ODAC
By Nadine Bouchard (VP, Regulatory Affairs, Head of Program Management) and Lisa Sanders, PhD (Sr. Director, Regulatory Affairs) Background To help in their decision-making, the US Food and Drug Administration (FDA) sometimes makes use of an Advisory Committee, as defined in various regulations. An Advisory Committee provides independent expert advice and makes non-binding recommendations to […]