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Articles by Rachael Aletti
10.16.26 -- Traversing Complexity In Breast Cancer Clinical Development
Webinar: Rethinking Starting Material: Whole Blood for Autologous T-Cell Manufacture Could whole blood offer a practical alternative to leukapheresis for selected autologous T-cell therapy workflows? This webinar explores fit-for-purpose starting-material selection, cell requirements, recovery, processing logistics, and key variables such as hold time and anticoagulant choice.
10.06.26 -- Early Drug Effects Missed, Trial Workloads Underestimated
Get more clinical research insight with our FREE newsletter Newsletter | October 6, 2026 Ready for the EU Clinical Trials Regulation? 6 Implications Sponsors Should Know The EU Clinical Trials Regulation is now redefining how clinical trials are conducted across Europe. From harmonised submissions and greater transparency to new operational demands, the CTR has wide-ranging implications for sponsors.
08.12.26 -- Tariffs, FDA Chaos, And BioSecure: How CDMOs Should Operate
Webinar: Building Robust Potency Assays with In-Cell Western™ Assay Protein Expression Readouts Building Robust Potency Assays with In-Cell Western™ Assay Protein Expression Readouts Developing reliable potency assays is critical for advancing cell and gene therapies from research through manufacturing. This webinar explores how the In-Cell Western™ Assay enables quantitative, cell-based protein analysis to support robust potency assay development.
Demonstrating The Value Of Investigational Drug Services Through Time-Based Metrics Original
By Rachael Aletti, Pharm.D. Standard volume-based measurements fall short in capturing the real demands of clinical trial management. Tracking simple counts, like dose counts or dispense numbers, overlooks the intricate labor required for complex study protocols, specialized handling, and intricate regulatory steps. Adopting time-based workload tracking offers a far clearer picture of operational reality.
07.17.26 -- Rethinking Trial Monitoring: From Medical Oversight To Remote Compliance
How Important Are Medical Monitors Under ICH E6(R3)? Discover how medical monitor-led implementation of ICH E6(R3) outperforms operations-only models across six critical performance dimensions. How Remote Pharmacy Monitoring Improves Trial Compliance Explore how leading IDS pharmacies are using remote monitoring workflows and digital accountability systems to improve accuracy, reduce site burden, and maintain audit readiness.
07.10.26 -- Managing Supply Disruptions In ATIMP Clinical Trials
Webinar: Rewriting the Code: Advances and Challenges in Pediatric Gene Therapy Pediatric gene therapy is rapidly transforming treatment for rare genetic diseases. Join Dr. Rachel Abu Taleb as she explores AAV, lentiviral, and CRISPR platforms, reviews lessons from approved therapies, and examines the scientific, regulatory, and access challenges shaping future innovation. Learn how these advances are redefining care and improving outcomes for children with rare diseases. Click here to learn more.
Demonstrating IDS Value With Time-Based Metrics
By Rachael Aletti, Pharm.D. As clinical trials grow more complex, Investigational Drug Services (IDS) teams play an increasingly critical role in managing investigational products (IP), ensuring protocol compliance, supporting patient safety, and enabling successful trial execution. Yet traditional volume-based metrics often fail to capture the true scope of IDS contributions.
How Remote Pharmacy Monitoring Strengthens Compliance and Streamlines Clinical Trial Operations
By Rachael Aletti, Pharm.D. Remote monitoring has become a transformative practice for Investigational Drug Services (IDS) pharmacies, enabling more efficient oversight of investigational product (IP) accountability while reducing the operational burden of traditional on-site visits.
Demonstrating IDS Value With Time-Based Metrics Original
By Rachael Aletti, Pharm.D. As clinical trials grow more complex, Investigational Drug Services (IDS) teams play an increasingly critical role in managing investigational products (IP), ensuring protocol compliance, supporting patient safety, and enabling successful trial execution. Yet traditional volume-based metrics often fail to capture the true scope of IDS contributions.
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