Pharmacovigilance & Safety
Pharmacovigilance is increasingly becoming a very crucial step in the drug and device development cycle, mostly due to increased regulations by the EMA and FDA (as well as local authorities) who are aiming to improve patient safety in both clinical development and post-market.
We offer both:
Pharmacovigilance Technology Solutions
The right safety database offers solutions to multiple challenges that a pharmacovigilance team faces – from the increasing complexity of the regulatory landscape to the integration of RWE.
We support you on how to choose the right technology and how to experience a smooth implementation and transition project.
Moreover, throughout the whole life cycle of your system, you will enjoy the services managed by our Technology Business Unit.
We will continue to support you with everything about the technology and services you may need.
We have a proven track record in defining user requirements and choosing a fit-for-purpose pharmacovigilance system, database and reporting system within a compliance strategy.
- Support in the definition of Business processes and User Requirements
- Validation plan and report, Risk Assessment, traceability matrix
- Architectural Design Definition
- Deployment, configuration, and test
- Systems integration
- Data migration from legacy PV systems
- Training for users
Get your data migration planned and executed by our experts to guarantee data consistency, integrity, and compliance with continually evolving regulations.
At Arithmos we have an extensive and long-time experience delivering data migrations in GxP environments and different domains, Regulatory, Clinical, Pharmacovigilance and Quality, from different sources to several target systems.
Get benefit from Arithmos accelerators to streamline your data migration.
End-to-end IT Services
Setting-up and maintaining a compliant PV system
The setup and maintenance of a pharmacovigilance system requires careful planning, collaboration with all the involved stakeholders, and adherence to regulatory guidelines.
To perform such tasks, it is important to take into consideration some relevant aspects:
- Regulatory Framework: pharmacovigilance regulations and guidelines specific to your country or region.
- Team with trained personnel and a suitable infrastructure with the necessary hardware, software, and data storage capabilities to handle safety information effectively.
- Standard Operating Procedures (SOPs) that outline the processes and responsibilities of each team member and cover data collection, adverse event reporting, signal detection, risk assessment, and risk management procedures.
- Reporting System allowing healthcare professionals to report adverse drug reactions easily. This can involve setting up a web-based reporting dashboard or using existing analytics platforms.
- Signal Detection tools which involve the systematic review and analysis of adverse event data to identify potential safety concerns through statistical methods and data mining techniques.
- Provide regular training to the pharmacovigilance team and healthcare professionals to enhance their understanding of adverse event reporting and safety monitoring.
- Conduct periodic internal audits to evaluate the effectiveness of the pharmacovigilance system and identify areas for improvement.
Pharmacovigilance is an evolving field, and it is essential to continuously monitor and improve the system’s performance.
Regularly review the processes, assess outcomes, and implement necessary changes to enhance the system’s efficiency and effectiveness.
Pharmacovigilance Technology Solutions | A strong network of Partners
With our network of Partners and our extensive expertise, we support you to adopt the right solutions for Pharmacovigilance and managed services model that fits your needs in the best way, including assessing your existing processes, technology and infrastructure to carry out possible optimisation scenarios.
Let’s maximise the value all relevant stakeholders can benefit
Pharmacovigilance and Safety Services
We provide Pharmacovigilance services to our customers to support their Pharmacovigilance processes and ensure business continuity.
We provide a complete portfolio of drug safety and risk management services ranging from case processing and reporting of Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) to the collection, monitoring, assessment, and analysis of drug safety information and the detection of new safety concerns.
Our team of Life Sciences experts will support MAHs in fulfilling Pharmacovigilance legal requirements and document delivery in the EU.
Case processing and management
With our team, you will have a full service in the collection, management and submission of reports of suspected adverse reactions to medicinal products according to:
- the legal requirements detailed in Directive 2001/83/EC [DIR] and Regulation (EC) No 726/2004 [REG] and GVP Module VI including revisions, for medicinal products for human use authorised in the European Union (EU).
- The Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products.
- The Medical Device Regulation (EU) 2017/745.
Electronic reporting is obligatory for marketing authorisation holders and sponsors of clinical trials.
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines that have been authorised or are being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
Pharmaceutical companies holding or applying for marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.
Signal detection and management
According to EU legal requirements, we support Marketing Authorisation Holders in monitoring a wide range of sources to detect information on a new or known adverse event that is potentially caused by medicine that warrants further investigation and in writing Risk Management Plans (RMPs) throughout the lifetime of the medicine as new information becomes available.
Medical monitoring for Clinical Trials
We provide expert Physicians to ensure the safety and integrity of patients/subjects enrolled in a clinical study, throughout the trial, from the initial design of the study to the final close-out.
Pharmacovigilance System Master File (PSMF) preparation and maintenance
The PSMF is a legal requirement in the EU. The PSMF shall describe the pharmacovigilance system and support/document its compliance with the requirements.
The content of the PSMF should reflect global availability of safety information for medicinal products authorised in the EU, presenting information on the pharmacovigilance system applied at global, regional and local levels.
Periodic Reporting (PSURs, DSURs, Addendum to Clinical Overview)
We provide full service in writing pharmacovigilance documents, according to EU legal requirements, intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the clinical development and post-authorisation phase.
We provide full service to Marketing Authorisation Holders of medicines in the European Economic Area (EEA) for monitoring the medical literature on their medicines and reporting individual cases of suspected adverse reactions into EudraVigilance and national safety databases according to EU legal requirements.
AI-validated platforms are proposed for medical literature monitoring services to detect safety information from the international and local scientific literature.
To enhance the efficiency of reporting and to provide simplification of the Medical Literature Monitoring process, we have implemented a scientific literature monitoring platform.
Thanks to the platform’s Artificial Intelligence and the support of our Team, you benefit from the following advantages:
- Research carried out simultaneously on multiple international and local databases of the highest relevance such as PubMed, Crossref, Dialnet, Directory of Open Access Journals, SciFLO.
- Automatic and faster search by keywords.
- Automatic exclusion of search duplicates.
- Full compliance with GxP and FDA 21 CFR Part 11.
- Management of high volumes of scientific articles.
Risk Management Plans (RMP) preparation and update
A Risk Management Plan (RMP) is a document submitted as part of the dossier that is evaluated by regulatory authorities before a medicine can be authorised. The RMP is regularly reviewed and it is updated as new information becomes available.
RMPs cover a medicine’s safety profile and include measures taken to prevent or minimise any harm to patients from the medicine.
Companies are required to submit an RMP to the European Medicines Agency (EMA) when applying for marketing authorisation.
Set-up and maintenance of an EU-compliant PV system
A pharmacovigilance system is defined as a system, adequate and effective (compliant), used by an organisation to fulfill its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
EU QPPV and Deputy
We support pharmaceutical companies and biotech’s with a full suite of services, including acting QPPV and deputy QPPV for pharmacovigilance in the EU:
- EU QPPV and/or Deputy services
- Availability 24hrs/7days and business continuity
Local Safety Officer/Local Contact Person for Pharmacovigilance
Our professionals are well qualified to cover the role of Local Safety Officer/ Local Contact Person for Pharmacovigilance and to liaise with local authorities on behalf of our customers. Over the past years, we have been engaging with numerous pharmaceutical companies to support them with Local Responsible Persons/ Local Contact Person for Pharmacovigilance in different countries, and, we have gained robust experience in providing such a role in Italy.
We will be happy to support you with our in-house resources and partners network which have full competence in local regulations
Our Pharmacovigilance and Safety Services team is made up of PV experts from seQure, one of the business units of Arithmos.
seQure, based in Italy, was founded in 2014 by our CEO Paolo Morelli, providing consultancy and services in Pharmacovigilance, Quality Assurance and Regulatory Affairs. The company became one of the outstanding providers in the Life Sciences industry.
In July 2022, we successfully merged Arithmos and seQure, with the mission to become a Strategic Partner providing end-to-end services for our customers.