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| A Full-Service Solution Partner Disrupting the Outsourcing Paradigm | inSeption Group offers a full-service solution designed to disrupt the current outsourcing paradigm, resurrecting a common-sense approach to rebuild business trust and confidence in a client’s selected vendor. Primarily focused on oncology, hematology, neurodegenerative disorders, and rare/orphan disease indications, with a specialization in cell and gene therapy, inSeption has been a solution for its’ clients who have experienced the progressive degradation of today’s outsourcing options. Contact them. |
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| The Diversity Mandate: Effective Strategies in Clinical Trials | Event | By Clinical Leader Live | The June 2024 release of the FDA’s guidance related to diversity in clinical trials gives more direction to the industry on this ongoing concern and details what trials need Diversity Action Plans (DAPs), what should be included, and how to submit them. Will this be the turning point that shifts the conversation surrounding diversity from marketing rhetoric to actual implementations? |
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| Understanding Safety Tactics, Regulatory Considerations In JAPAC | White Paper | By Hye Jin Choi, R. Ph. and Dr. Jayawant Fuke, IQVIA Safety & Regulatory Compliance | As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance. |
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| Similarities And Differences Between The CTA And IND | Infographic | Veristat, Inc. | Utilize this infographic when considering the purpose, content, and procedural similarities and differences between the Clinical Trial Authorization and Investigational New Drug Application. |
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| IRB Solutions To Empower Better Research Programs | Brochure | Advarra | Irrespective of a project's scale, therapeutic focus, or the size of its investigative team, discover how Advarra works to stand as a trusted partner in conducting efficient and responsible research. |
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| The Role Of The CRO Is Changing. Why? | Guest Column | By Jeremy Weitz, Biogen | The role of the CRO is in flux. As sponsors shift to full-service outsourced (FSO) models to functional service provider (FSP) models, CROs are finding themselves redefining their role in the outsourcing relationship. Jeremy Weitz explains in this two-part series. on the changing role of the CRO. |
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| Functional Service Provider (FSP) | Product | ProPharma | At ProPharma, we offer a unique approach to the traditional Clinical Research Organization (CRO) Full-Service Provider (FSP) model. |
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| Oncology Clinical Development | Datasheet | IQVIA Biotech | Our extensive oncology expertise coupled with an end-to-end approach helps accelerate your clinical programs, giving you the confidence to bring breakthrough treatments to patients. |
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| The Asia Drug Development Advantage | Product | Avance Clinical | Explore advanced technology and operational support for North American and European biotechs that are looking to Asia for later-phase multi-regional studies. |
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CHOOSE YOUR OWN ADVENTURE |
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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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