PHARMACOVIGILANCE & SAFETY SERVICES
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 MaintenanceOur 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 DatabaseWith 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 SUSARsPer 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 & UpdatesSoterius 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 & UpdatesSoterius 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.
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.
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.
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.
We can support sponsors in authoring core company data sheets.
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.
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