Pharmacovigilance is a of paramount importance for the early detection of risks associated with the use of drugs.
The 4Clinics safety team offers support in the detection, the surveillance, the prevention and the assessment of adverse events collected on drugs, used in the clinical trialsor in the post-authorisation setting.
We know what Pharmacovigilance requires in terms of accuracy and deadline respect in monitoring, managing, reviewing and reporting of clinical safety cases.
Together we assess the benefit, efficacy and risk of the drugs and improve in patient care and safety.
We ensure your drug safety activities are performed in compliance with all regulatory requirements.
The 4Clinics Safety team has the expertise and the skills to meet your requirements, with a combination of strengths such as good understanding of the regulations requirements, quality focus, timeline commitment and flexibility.
Our certified safety team is experienced in a variety of therapeutic areas and regularly trained on latest safety legislations and regulations.We are aiming to establish long term relationships with our customers in order to ensure the safety of all patients using your drugs.
Based on the expertise of our teams and on their commitment to the success of your projects, 4Clinics Safety team works together in every step of your process in insuring the best management of your data with the right methodology, in compliance with the highest quality standards:
- Perform initial safety review and initial evaluation of adverse events: prioritization of cases based on seriousness and expectedness
- Track safety cases
- Process serious and non-serious spontaneous/clinical trials cases into the client safety database
- Manage adverse events from pregnancy cases and complaints
- Handle initial case and follow-up AE reports
- Code medical terms using appropriate dictionary (MedDRA)
- Write narratives summarizing all relevant medical information for individual case safety reports
- Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters
- Ensure validation and quality control of safety cases
- Perform medical evaluation and assign internal/company causality and perform listedness/expectedness assessment as applicable
- Generate CIOMS reports Prepare periodic safety update reports (PSURs)
- Realize a medical review
- Perform a Regulatory reporting
- Provide signal detection analysis : quick identification of potential unexpected side effects in the post marketing trials
- Identify cases reported in the published and scientific literature using search engines
- SAE Reconciliation between the safety database and the clinical database.
4Clinics Safety team has significant experience in different safety databases such as:
- Empirica trace,
- Other client dedicated system.