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Clinical Ink

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eSource: Reducing Site Workload for Better, Faster, Safer Clinical Trials

More sponsors and CROs are looking for new ways to better leverage investigative site relationships to improve clinical trial performance. To this end, some clinical organizations have adopted electronic source (eSource) to help improve study quality and efficiency - for both sponsor and site. Unlike traditional electronic data capture (EDC), SureSource, Clinical Ink’s eSource platform, was designed from the beginning to minimize clinical trial complexity for site users. As SureSource adoption increased, study teams began to see an improvement in data quality, operational efficiency and ease of use compared to traditional methods (paper and EDC). A Site Impact Survey provides scientific evidence regarding the impact of SureSource from 517 site users. Results confirm it significantly reduces workload, lessens queries, and improves data quality compared to paper and EDC. In this white paper, we quantitatively evaluate survey outcomes, provide qualitative feedback from survey respondents, and highlight the observed benefits of SureSource for transforming clinical research.
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News and Press Releases

PTC Therapeutics Reports the Initiation of the Second Stage of the FITE19 Phase 2/3 Clinical Trial Evaluating PTC299 for the Treatment of COVID-19

PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced the initiation of the second stage of the FITE19 clinical trial to assess PTC299 in COVID-19 patients. PTC299 is an oral investigational drug with a novel dual mechanism of action that has the potential to inhibit viral replication and attenuate the uncontrolled inflammatory response that ensues after infection.
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White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
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