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Soterius has a truly global presence capable of providing comprehensive clinical and post marketed safety services, that include aggregate report writing, signal detection and management, global literature surveillance, risk management, case processing and reporting.

1. Clinical Safety Services: We provide end to end services to support clinical stage products portfolio of our clients as a centralized pharmacovigilance operation, integrating clinical CRO, sponsor colleagues and technology providers into a single unified operation. Case Intake, Literature Monitoring, Safety Management Plan Writing, DSUR Writing, Signal Detection, IB Writing and Update, Case Processing and Reporting, Responsible Person Services and Safety Database Services. We also have unique in-house technology tools to facilitate EDC Intake, Reporting, and Notifications Management with sites.
2. Post Marketed Safety Services: Conducting large scale operations for global pharmaceutical companies that require hundreds of staff in specific processes, to small and mid-size corporations that require handling of possibly a complete end-to-end portfolio of activities, is something we dedicatedly do for our clients. Our services include Case Intake, AI and Non-AI Based Technology stacks for complete handling of global intake, Regulatory Cases Triage, Reporting, Signal Detection and Management, Aggregate Report Writing, Risk Management Plan Writing and Updates, QPPV and Local Safety Representative in 60+ Countries.
3. Safety System Setup – SOP Authoring & Integration: Soterius can provide a fully hosted and managed Safety Database in order to free up your resources and bring cost effectiveness. We can set up a complete Pharmacovigilance System, accompanying Standard Operating Procedures and other Technical Documents, Work Instructions etc. that are relevant to the size and complexity of your business.
4. Case Intake, Processing & Submissions: Our teams of HCPs and medical doctors are experts in Case Triaging, Sending Notifications and Case Processing. We perform Review of Case Data from Spontaneous, Health Authority, Literature, and Clinical Trial sources in the Safety Database – both for expedited and periodic reporting. We have the required experience and knowledge to submit expedited Safety Reports to Regulatory Agencies, Clinical Trial Sites and Ethics Committees.
5. Global Literature Search & Review for Safety Relevant Publications: Soterius’ literature surveillance includes a thorough search of literature databases like Embase, PubMed, etc. through pre-defined search strategies. A typical search strategy consists of drug terms combined with specific terms, using Boolean operators to optimize precision and recall of the literature output. We use our own- or third-party technology tools to further process literature abstracts, making summarized, coded, and processed results available to our clients.
6. Aggregate Reports Authoring – PSUR, DSUR, ASR & PADER: We prepare aggregate reports as per applicable regulatory requirements. Our team has the expertise to support Clinical Trial Sponsors and Marketing Authorization Holders in presenting a comprehensive, thoughtful review and evaluation of pertinent safety information collected during the reporting period for the drug under investigation or approved in a region. We help our clients actively manage reporting calendars, coordinate information gathering, when required, and produce submission ready aggregate reports.
7. Signal Detection & Signal Management: Soterius can support the sponsor in performing signal detection activities on various data sources such as case data captured in databases (Safety and/ or clinical), literature analysis, regulatory websites, other data sources. Our team also supports in presenting a comprehensive and thoughtful analysis of safety information as a structured Signal Detection Report that is discussed with various stakeholders and in the Safety review committee meetings. Any potential signals thus identified are validated by assessing the cumulative datasets and targeted data outputs.
8. Medical Monitoring: Soterius can provide sponsors with the medical monitoring services. Soterius has a team of medical monitors with hands on experience of medical monitoring and with diversified experience across therapeutic areas such as Oncology, Neurology etc. The medical monitors can effectively and on a real time basis manage the site queries and can support the sponsors in review of key safety data and participate in various safety committees, as required.

Our Technology Solutions 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 artificial intelligence

1. UNITYAI.LIT: Our complete literature abstract and full-text article processing software platform allows automatic intake, categorization, annotation, and pre-processing of an ICSR so that it can be processed and transferred as a near-ready case in E2B format into a safety database. The platform allows for reporting for signal detection, aggregate reports, and in-depth data mining. The system is fully validated and new clients addition on our multi-tenant SaaS-based platform takes a matter of days to configure and roll out.
2. UNITYDx: Soterius offers its in-house tool, UNITYDx, which automates sending and tracking of SUSAR notifications to the Principal Investigators (PI) during a clinical trial. System integration and standardization allow UNITYDx platform to work with any of the database systems. Continuous tracking provides audit reports and tracking for inspections. Multi-channel communication hub ensures prompt, compliant, efficient, and secure communication between Clinical Trial sites, Safety Teams (CROs and Sponsors), and Clinical teams.
3. UNITYx – Multi Intake & Processing: Our Intake platform allows intake from any structured data source with a 100% accuracy rate, which means sources such as medical information, clinical cases from EDC and other quality systems can be integrated into the safety database immediately. We integrate Regulatory (L2a) cases, Partner Cases and Literature Cases from our other platforms or directly from source(s). A flexible system that brings immediate returns through reduced processing times, higher accuracy and improvement in compliance through better data visibility and tracking.
4. UNITY.ai: Our AI Based Triage and Case Processing Platform can process hundreds of cases in a minute, identifying main case entities, MedDRA Coding, detecting seriousness, and producing an output to integrate with any Safety Database or our UNITYx and OLMS systems. Our platform has exceeded 98.88% in terms of accuracy against false negatives. Estimated cost savings through use is in excess of 45% for most deployments. Accuracy improvement through use of client’s previously processed data allows for acceleration of results for companies with smaller regular turn volumes.
5. Hosted Safety Database: We are able to provide pre-validated, deployment ready instances of the world leading safety database systems. Systems include latest features around intake integration, reporting, and workflow management – making a deployment using our packaged approach the most cost effective for small to mid-size global companies and CROs. We can provide hosted safety database through both, ARIS Global and Oracle.

1. Transition Management and Hiring Strategy: Our team has experience in transitioning complex case processing and aggregate report writing projects from sponsors and other vendors. We understand critical handover/takeover steps that are needed to ensure nothing is missed and communication is timely and relevant. Hiring more experienced resources initially helps in knowledge transfer and development of further SMEs in the team. This will be our investment into the project at no extra cost to you.
2. Trusted Team: Our colleagues have handled aggregate report authoring and submission projects for large global pharma companies (65+ countries for submission and the entire mature products portfolio) and we were recently audited and approved to carry out case processing, QC, and other activities for a Top 5 global pharma company with a 200 people hiring requirement.
3. Experience in Consumer Products and Innovator Products: We author aggregate reports, provide medical review and submission services covering a number of consumers, nutraceutical and cosmetics products. We understand the nuanced requirements across such product portfolios, and at the same time, we handle complex innovator products undergoing various stages of clinical trials. With our team that will lead and transition your project, you will get an immense amount of knowledge-base to make the transition smooth.
4. Technology Superiority: Our technology solutions are deployed at a Top 3 global pharma company with more than 4,000 users. We have developed, in-licensed and acquired cutting edge technologies in case processing and other PV activities that could be deployed at the right time to bring further efficiencies in your entire PV Operations. Our solutions allow us to work securely and with robust data integrity assurance. We are also one of the preferred CROs with ARISg, with significant experience in deploying and carrying out transactions on their LSMV platform.