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| How PDS Biotech Approached FDA Meetings For Its Phase 3 Cancer Trial | Guest Column | A conversation with PDS Biotech Chief Medical Officer Kirk Shepard, MD | PDS Biotech CMO Kirk Shepard reveals his team’s interactions with the FDA as it sought to begin its Phase 3 trial for the treatment of HPV-positive recurrent and/or metastatic head and neck squamous cell carcinoma. |
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| The State Of Rare Disease Clinical Trials | Article | Mednet | Gain insight from clinical trial needs in the rare disease sector and learn how technologies and supporting procedures determine how quickly and effectively new medications can get to market. |
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| Streamlined Site Study Start-Up | Article | Cognizant | Explore the critical process of Study Start-Up (SSU) in clinical trials, with an emphasis on the collaborative efforts of sponsors and research sites to enhance efficiency and reduce timelines. |
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| Siteless DCTs Are Real … And Happening Now | From The Editor | By Dan Schell, chief editor, Clinical Leader | Siteless DCTs (decentralized trials) are rare, but Praxis Precision Medicines is running one now for patients with essential tremor (ET). Marcio Souza, PharmD, the company’s president and CEO, talks about why they chose this model and the surprising speed at which it is progressing. |
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| You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. 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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