Soterius, Inc., a leader in providing customized technology solutions, proudly announces the successful launch of UNITYdx™, a Safety Document Distribution System designed to streamline the sharing of critical safety documents in clinical research settings, for another client. Tailored for our client, a prominent US-based pharmaceutical company running multicentric clinical trials, UNITYdx promises efficient document distribution, tracking, and compliance management.
Key Features of UNITYdx:
- Seamless Sharing: UNITYdx facilitates the seamless sharing of critical safety documents, such as 7/15-day SUSARs, DSURs, etc., with Site Contacts, including Investigators, Study Coordinators, CRAs, and CRO personnel.
- Efficient Document Tracking: UNITYdx tracks the delivery of safety documents, ensuring timely and secure distribution. Real-time compliance updates enable stakeholders to stay informed about the status of document acknowledgments.
- Compliance Assurance: UNITYdx plays a crucial role in ensuring compliance with EC/IRB notification requirements. It automates the notification process, reducing the risk of oversights and enhancing regulatory compliance.
- Automated Reminders: UNITYdx sends timely reminders to Site Contacts, minimizing the chances of missed acknowledgments or EC/IRB notifications. This proactive approach enhances overall communication and accountability.
Positive Customer Impact
UNITYdx will enable our client to effortlessly manage their Safety Document compliance without having to keep track of documents manually using excel spreadsheets or having to follow-up repeatedly with numerous Clinical Sites to acknowledge receipt of safety documents.
UNITYdx is the result of years of supporting our clients who struggle to maintain compliance for safety document sharing with Clinical Sites and multiple warnings received by Sponsors of Clinical Trials from Regulatory Authorities for failing to maintain this compliance. It is a product of Soterius’ commitment to reduce the burden of compliance management for our clients and enable them to focus on bringing their product to the market.
Quote from our CEO, Mr. Suneet Walia:
“We are excited to launch UNITYdx to another customer this year, a revolutionary Safety Document Distribution System crafted to meet the unique needs of clinical research compliance management. This system not only streamlines document sharing but also enhances compliance and communication across stakeholders. We believe that UNITYdx will significantly contribute to the efficiency and success of our client’s clinical research operations.”
Soterius is a strong team of pharma professionals who design customized, innovative, and cost-efficient 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.