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The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline. [3] Improving patient recruitment rates offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As ...
Patient recruitment; Patient follow-up; Informed consent form (ICF) translation into vernacular languages [dubious – discuss]. In Europe, this is often done by the Sponsor or CRO; Site initiation and trial close-out operations; Trial-related documents archival and maintenance; Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC
Singapore's first publicly funded drug candidate, ETC-159, which was discovered and developed through a collaboration with Duke-NUS Graduate Medical School, advanced into Phase 1 clinical trials in July 2015. This drug targets a number of cancers, including colorectal, ovarian and pancreatic cancers, which contribute to a significant proportion ...
The company offered clinical data management, clinical trial execution services, pharmaceuticals, drug development, financial partnering, and commercialization expertise to companies in the biotechnology, pharmaceutical and healthcare sectors. In 1982, Dennis Gillings founded and incorporated Quintiles Transnational in North Carolina. [23]
A clinical update of the ongoing MUSIC-HFrEF (NCT0470384) Phase 1/2a trial of SRD-001 in the U.S. was featured in a late-breaking presentation at the American Society of Gene & Cell Therapy (ASGCT) in May 2024. The Phase 1/2a trial is expected to complete its enrollment, followed by an interim data readout and the randomized Phase 2b in 2025.
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
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East Horizon In 2021, Cytel released Solara, the industry's first-to-market clinical trial strategy platform for simulation-guided clinical study design and selection. In 2024, Cytel expanded the capabilities of Solara by incorporating statistical tests from its Windows-based software East and added the ability to extend its native tests by ...