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June 16-20, 2024

DIA 2024 Booth #1738

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Join us in San Diego, CA from June 16th to the 20th for DIA 2024! The DIA 2024 Global Annual Meeting invites industry, regulators, governments, academics, innovators, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in San Diego, DIA 2024 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being.

As part of the conference, join CRIO President and COO, Jonathan Andrus, for an informational session titled Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features on Tuesday, June 18th from 1:15-2:15pm.

Decentralized Clinical Trials have many advantages, including the potential to allow for fewer in person visits which may enhance convenience for trial participants and may reduce the burden on caregivers, to expand clinical trial access to more diverse populations, and to facilitate research on rare diseases.

Historically, clinical trials have included a variety of decentralized features for many years, meaning not all trial-related activities involving participants have taken place at traditional clinical trial sites.  For example, laboratory tests are often conducted by clinical laboratory facilities at locations remote from traditional trial sites, digital health technologies, such as electronic patient-reported outcomes, are often used to collect data directly from trial participants, and more recently the COVID-19 pandemic has necessitated the use of electronic informed consent to obtain consent and telehealth to conduct trial visits remotely.

Sponsors and investigator responsibilities for decentralized clinical trials are similar to their responsibilities in a traditional trial. For DCTs, the risks to the quality and the integrity of the trial and study data that’s being collected lie within these sponsor and investigator responsibilities. Due diligence is necessary to ensure sponsor and investigator responsibilities are met, to ensure the integrity and quality of the clinical trial data and to insure inspection readiness. For DCTs, sponsors should place their emphasis on trial participant safety, ensuring that technologies used in the trials are fit for purpose, and on understanding the data flow and having robust and well-defined data collection, handling and management procedures.

Click here to learn more.

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