Learn more about us
We are Soterius – a strong team of experienced professionals from the pharma industry. We 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 with big data in pioneering customer centric solutions.
Our technology offerings include intake solutions that guarantee 100% accuracy, AI based case triage platform, Literature Screening and Case Processing Platform and Clinical Document Exchange platform for drug safety area and a pathbreaking HCP, Commercial and MSL engagement platform for medical affairs areas. 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 at a global level.
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 regulatory reporting. 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.
Our global team transforms the way in which companies have handled the medical affairs function. We integrate intelligence, real world evidence and technology and place alignment and enhanced engagement at the heart of our services.
Soterius innovative technology solutions include engagement tools and communications platforms to create a unified and compliant medical access facility within sponsor organizations. We help thousands of commercial and medical professionals create enduring and fulfilling interactions – connecting stakeholders across diverse platforms.
Explore your specific interests – simply click on the tabs below for more information!
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.
- 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.
- 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.
- 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.
- PSMF Preparation and Maintenance: Our team has prepared several Pharmacovigilance System Master Files and accompanying submission relevant documents for countries where PSMF requirements exist. Documenting the entire working system for safety related activities is good practice, even when PSMF requirements are not mandatory – we help clients systematically document their safety related processes.
- 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.
- Reconciliation with Partners, Clinical Database: With the objective to ensure data consistency between Safety and Clinical Databases, our team designs reports, electronic tools and computerized processes to ensure a seamless reconciliation process. We help companies achieve speedy data lock at the close of a trial.
- 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.
- 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.
- Analysis of Similar Events for SUSARs: Per 21 CFR 312.32, the sponsor must identify in each IND safety report all IND safety reports previously submitted to FDA concerning a similar suspected adverse reaction and must analyze the significance of the suspected adverse reaction in light of previous, similar reports or any other relevant information. We support our clients by authoring the analysis of similar events for SUSARs.
- CSR Narratives, IB Authoring & Updates: Soterius supports sponsors of clinical trials with authoring abbreviated narratives for Clinical Study Reports, Investigator Brochures, Development Safety Update Report, and for Briefing Documents.
- 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.
- RMP/REMS Authoring & Updates: Soterius can support sponsors in authoring and update of the Risk Management Plans (RMP) and Riks Evaluation and Mitigation Strategies (REMS) to support the marketing authorization applications. The team can support in authoring and update of RMPs/ REMS across regions.
- QPPV/LRP Services: Soterius can provide sponsors with the services of QPPV, Responsible Person for Clinical Safety for the EU (RPEV) and Local Safety contact.As part of the pharmacovigilance system, the marketing authorisation holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (QPPV). Soterius’s QPPVs have adequate theoretical and practical knowledge for the performance of pharmacovigilance activities. The QPPV shall be responsible for the establishment and maintenance of the marketing authorisation holder’s pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements. The RPEV supports the sponsors in overseeing safety reporting requirements for the ongoing studies, performing registration of RP in EudraVigilance and managing user access for the sponsor in EudraVigilance database.
- 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.
- Regulatory Responses: We can support sponsors in providing responses to various regulatory agencies’ requests including queries on risk Management plans, signal assessments, aggregate reports, investigator brochures, marketing authorization applications, inspection queries etc. Our team can support the sponsors with the tracking of timelines, data collection, co-ordination with various stakeholders, as required. Our team can also perform the critical analysis of safety data, as per the regulatory requests and help with presenting a comprehensive, thoughtful review and evaluation of pertinent safety information, as per the regulatory agency query.
- CCDS Authoring: We can support sponsors in authoring core company data sheets.
- Regulatory Intelligence: The regulatory intelligence process at Soterius includes identifying relevant regulatory information from various sources and communicating the information to the key stakeholders for analysis with the overall intent of monitoring the existing and changing regulatory landscape for opportunities to create/modify processes and associated documents.We can perform regulatory intelligence activities for our clients to obtain information regarding the current trends, regulatory updates, changes in the guidances, etc. This is done through a review of various regulatory websites, literature review, etc. Product-specific regulatory/market intelligence can also be built into the process, as required by the client. The information obtained from such a search is assessed for its impact on existing processes, organizational strategy, training, or other procedures. After a thorough impact assessment, a decision may be taken regarding action items, deliverables, and timelines.
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Share your details to set up a meeting with our experts:
US, Canada, EU and ROW – 61 Countries’
Integration with existing Safety Systems
30-50% Typical Savings, 99.x% Quality Scores
30+ Countries LRP, QPPV
Drugs, Devices Nutraceuticals, Cosmetovigilance, Biologics & Vaccines