Wrapping Up a Successful Clinical Trial: Close-Out Visit at Hayya Life Science

At Hayya Life Science, every clinical trial follows a detailed and structured process, and we’re proud to reach the critical Close-Out Visit (COV) stage for one of our active sites in Indonesia. As a trusted CRO in Indonesia, we understand the importance of this final phase, ensuring the trial is completed in full compliance with the study protocol and regulatory requirements.

Our team is meticulously verifying that all Case Report Forms (CRFs) are finalized, accurate, and aligned with the source data. This step is essential to confirm that the study data is clean and ready for analysis. Additionally, we are managing the reconciliation and appropriate disposition of the investigational product (IP) as per protocol guidelines, whether through return or destruction. Resolving any outstanding data queries, deviations, or issues is also a key focus during this phase, ensuring there are no open items that could impact the integrity of the trial. We are reviewing the site’s storage and archiving of essential documents to guarantee that everything is properly organized for any future audits or inspections.

The Close-Out Visit is not just about ending a study—it’s about ensuring that all regulatory and ethical obligations have been met and that the study data is fully documented for the next steps, whether that’s reporting to regulatory authorities or moving on to the final study analysis. Hayya Life Science remains committed to supporting clinical trials with precision and attention to detail, even amid the challenges posed by the pandemic. If you’re looking for a reliable CRO or need SMO services to streamline your trial operations in Indonesia, our team is ready to collaborate with you and provide the expertise needed to ensure smooth study execution from start to finish.

Let’s discuss how Hayya Life Science can support your next clinical trial. Reach out to: bd@hayyalifescience.com.

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