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Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

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Transforming Clinical Trial Safety

Background

A pharmaceutical company conducting multiple clinical trials across various sites in the United States faced challenges in ensuring timely sharing of SUSARs with all participating sites and obtaining acknowledgments from each site. Additionally, certain sites delayed/failed to furnish documentation regarding their decision not to notify the local Institutional Review Board (IRB) or ethics committee (EC) of SUSARs, citing adherence to their internal Standard Operating Procedures (SOPs).

Challenges

  • Communication: Inconsistent communication and acknowledgment from
  • Documentation: Incomplete/delayed documentation from some sites due to nonnotification of the SUSARs to their Local IRB as per their internal SOPs
  • Manual Processes: Manual processes leading to inefficiencies, potential errors, and delays in sharing critical trial information.

Solution

  • Software Implementation: UNITY™dx was implemented by integrating it into the existing SUSAR Management workflow to ensure a cohesive workflow.
  • Customization: UNITY™dx was tailored to meet the specific needs of the Sponsor’s clinical trials, specifically allowing them to record the reason why a site did not want to notify their local EC/IRB. Requirements for delegation of PI responsibilities to sub-Investigators were also incorporated.
  • Training: On demand basis; Training Modules and FAQs for all roles were available on UNITY™dx for users to access as needed.
  • Support: UNITY™dx has a support page available on login, users are able to raise support queries that reach a dedicated support team.

Results

  • Improved Communication: UNITY™dx facilitated realtime communication between the Sponsor/CRO and all participating sites, ensuring consistent and timely information sharing.
  • Timely Acknowledgments: The automated acknowledgment reduced response times, eliminating delays caused by manual acknowledgment processes.
  • Regulatory Compliance: UNITY™dx streamlined the site notification process, ensuring that all required information was promptly reported to the sites.
  • User-Friendly Interface: The intuitive interface of UNITY™dx minimized the need for extensive training, allowing sites to adapt quickly to the new system

About UNITY™dx

Soterius offers its in-house tool SUSAR Notification , UNITY™dx, which automates the sending and tracking of SUSARs to the Clinical Trial Sites. System integration and standardization allow UNITY™dx to work with any standard safety database. Multichannel communication hub ensures prompt, compliant, efficient, and secure communication between Clinical Trial sites, Safety Teams (CROs and Sponsors), and Clinical teams.

Conclusion

  • Successful implementation of UNITY™dx in multisite clinical trials.
  • Positive transformative impact of automation technology on regulatory compliance processes
  • Automation not only addressed existing challenges but also improved overall efficiency and collaboration in the management of complex clinical trials.

About Soterius

Soterius is a strong team of pharma professionals who design customized, innovative, and costefficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up to date insights let us combine agile, people powered intelligence in pioneering customer centric solutions. Our innovative technology solutions include engagement tools and communications platforms to create a unified and compliant medical access facility. With a strong global presence, we provide comprehensive clinical and post
marketed safety services, that include aggregate report writing, signal detection and management, global literature surveillance, risk management, case processing and regulatory reporting.

We use state-of-the-art technologies to solve complex safety operations problems, be it case processing, intake, site reporting for clinical trials, or literature search and management. We have one of the most accurate solutions for case intake and case processing using AI. Like This Blog?

We support companies from the initial development stage of a drug/vaccine to the approval and ultimate marketing of the therapy, supporting ongoing operations and regulatory commitments globally.

Authors

Tanvi Chaturvedi

Tanvi Chaturvedi

Associate Director, PV Operations & Technology

Tanvi is a pharmacist with over 12+ years of experience. She has expertise in pre-approval and post-marketing safety and has managed end-to-end project setup for clients including process development, database setup with data migration and validation, transition of PV and MI services and team onboarding. She has experience across various PV domains like case processing, literature management, regulatory intelligence and pharmacovigilance quality assurance. She is eligible to provide Responsible Person for EudraVigilance (RPEV) services to Sponsors of
Clinical Trials in the EEA.

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