Vigilance & medical information
AIXIAL offers pharmaceutical, biotechnology, medical device, nutritional and cosmetics companies full coverage for post-marketing vigilance and product safety in Phase I to IV and, post-marketing clinical studies across a broad range of therapeutic domains.
AIXIAL collaborates closely with its clients to ensure that services are provided in the manner that fits most appropriately fits with the client’ strategic and operational requirements.
If you want to ensure the safety of your products and the compliance to regulation you need:
- A high level of expertise.
- A medical and a pharmacological analysis.
- Continued monitoring and evaluation of the product Benefit/Risk ratio.
- Organizational skills.
- Communication talents.
- A range of technical solutions.
- A rigorous Quality Assurance securing your processes. Compliance focus.
RESPONSIBILITIES, PV SYSTEM AND PROCESSES
- EU QPPV and Local QP responsibilities.
- Creation and maintenance of Pharmacovigilance System and its Quality System, according to the Good Pharmacovigilance Practices.
- Creation and maintenance of Pharmacovigilance System Master File.
- Writing of customized Safety Data Exchange Agreements, SOPs and Instructions.
- Audits and inspections readiness.
- Registration of organization in the EMA Eudravigilance database and testing phase with National Competent Authorities.
- Registration of medicinal products in xEVMPD.
- Dedicated pharmacovigilance database or direct access to Client database.
- Handling of Adverse Drug Reactions and special situations incl. collection, data entry, MedDRA coding, narrative writing, Quality Control, request for follow-up, medical assessment of seriousness, expectedness, causality, Company comment and expedited reporting of Individual Case Safety Reports (ICSRs) to Eudravigilance and NCAs.
- Literature research on Embase, Medline, other local journals (weekly or triggered).
- Signal management.Periodic Safety Report writing: PBRER/PSURs, incl. use of MedDRA SMQ.
- Risk Management Plans including Pharmacovigilance Plan, Risk Minimisation Actions Implementation.
- Medical information.
- Participation in meetings with the Competent Authorities.
- Training of PV staff, sales teams, affiliates and distributors.
- Review of safety sections of educational material.
PRE-MARKETING – CLINICAL TRIALS
- Handling of Serious Adverse Events and special situations incl. collection, data entry, MedDRA coding, narrative writing, Quality Control, request for follow-up, medical assessment of seriousness, expectedness, causality, Company comment and expedited reporting of SUSARs to relevant entities (Eudravigilance, NCAs, Ethics Committees, investigators).
- Periodic Safety Report writing: DSUR, including use of SMQ.
- SAE Reconciliation.
- Medical monitoring and eligibility verification.
- DSMB set-up and management, definition and analysis of study safety endpoints.
- eCRF set-up for safety reporting.
- Identification and management of adverse events of special interest.
- Training of clinical team and investigational site staff.
- Medical writing of study reports.
- Development Risk Management Plans.
MEDICAL DEVICE VIGILANCE SERVICES
- Pre and post-marketing vigilance services for all classes of Medical Devices according to the EU MEDDEV guideline.
- Preparation of customized SOPs for Medical Device Vigilance system and Incidents reporting procedures.
- Incident management: Case reception, data entry, narratives, medical assessment and Quality Control.
- Incident Expedited Reporting: Preparation and submission of Manufacturer Incident Reports and Field Safety Notice to NCAs where necessary.
- Periodic Vigilance Reports and Trend Reports.
- Food supplement vigilance