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| Right-sized for biotech success | It’s not the size of your company. It’s the size of your passion and your dedication to improving patients’ lives that IQVIA Biotech is uniquely built to serve. There is nothing bigger to us than your success. We’ve got you. |
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| FDA Finalizes Guidance On Dose Optimization For Oncology Therapies | Guest Column | By Marjorie Zettler, Ph.D., MPH, Conjugate Group | The FDA recently finalized its guidance on "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" — with a few notable updates since its draft. |
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| How, Why, And When To Apply For An Orphan Drug Application | Article | By Hema Balasubramanian and Mamta Puri-Lechner, Halloran Consulting | Gain access to strategic insights for clinical trial sponsors on targeting an orphan drug designation and the logistical considerations involved in pursuing this path from the outset. |
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| The Impact Of sIRB Mandates On Study Teams | Article | By Frank Conte and Stephanie Pyle, Advarra | Explore the practical implications faced by investigators and their support staff, such as navigating new bureaucratic procedures and adhering to revised regulatory requirements. |
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| Local Affiliate Product Services | Datasheet | IQVIA Safety & Regulatory Compliance | Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies. |
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| Flow Cytometry And PBMC Isolation | Brochure | Altasciences | Altasciences’ clinical facilities are integrated with state-of-the-art flow cytometry laboratories. We are equipped with advanced platforms and staffed by a dedicated team of in-house experts. |
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| Functional Service Provider (FSP) Value Proposition | Brochure | ProPharma | Partner with us to co-create strategies and achieve operational excellence with our FSP capabilities, providing value as an extension of your team to advance your development programs. |
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| DIA/FDA Oligonucleotide-based Therapeutics Conference | Date: Oct. 28-30, 2024 | Location: Washington, D.C. The DIA/FDA Oligonucleotide-Based Therapeutics Conference brings together leading experts to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. Developed collaboratively by regulators, industry professionals, and academics, the program covers a wide range of topics from the nonclinical, CMC, and clinical areas. The conference offers a unique experience with multiple perspectives presented, and the opportunity to interface with regulators from around the globe. Learn more. |
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| You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences. - Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Decentralized Trials | Trial Management (Wednesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
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