Ethicare Pharmacovigilance is uniquely focused on providing comprehensive and customized pharmacovigilance (PV) services and offering specialized services to augment or support any drug safety department, tailored to fit your needs.
As a specialist PV service provider, Ethicare guarantee its clients about compliance, conformity, continuity and reliability. Ethicare always adhere to the highest quality standards, with a robust quality management system and corrective action and preventive action (CAPA) management process. Always in line with regulatory documents, such as GVP modules, and with a fully defined disaster recovery and business continuity plan in Place. Ethicare’s Client can only rest assured that they have chosen the best PV service provider.
Ethicare Provides Comprehensive Pharmacovigilance Drug Safety Services to pharmaceutical, biologic, innovator and generic product companies. All documentations are in accordance with FDA, ICH, CIOMS and GCP standards and guidelines.
CLINICAL TRIALS AND POST MARKETING SAFETY
The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfil the stringent obligations. Ethicare’s Pharmacovigilance team is comprised of healthcare professionals with vast experience in both direct patient care and industry-specific pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services.
Clinical Trial Safety
- Serious adverse event (SAE) management including collection, documentation, active query process and follow-up
- SAE processing within required timeframes in a database available at our collaborative partner and other non-commercial systems.
- Qualified medical review of all SAEs for data completeness and medical senses
- Appropriate Medical Dictionary for Regulatory Activities (MedDRA) coding
- Regulatory reporting to authorities, investigators and ethics committees
- Electronic safety reporting according to ICH E2B
- Preparation and submission of aggregate Clinical Safety Reports
- Data reconciliation of pharmacovigilance and clinical trials databases
- Writing of patient safety narratives for study reports Collection and assessment of AEs originating from interventional or non-interventional clinical trials.
- Compliance monitoring
- Submission of SUSARs to the Health Authorities, Hospital Scientific Committees and the Investigators.
Post Marketing Pharmacovigilance services
- Preparation and implementation of a Company Pharmacovigilance System which includes
- Writing and reviewing of Standard Operating Procedures (SOPs).
- Preparation, compiling and maintenance of the Pharmacovigilance System Master File (PSMF) along with the submission to the Health Authorities.
Collection, Processing and Evaluation of Adverse Events (AEs), includes
- Collection, assessment and submission to Health Authorities of AE reports originating from Health care professionals, consumers, Health Authorities and literature reviewing.
- Implementation of electronic reporting of Individual Case Safety Reports (ICSRs)
- International and Local Literature review for screening of AEs and special situations.
- MedDRA Coding of AEs
- Database build and statistical analysis of AEs occurrence.
- Medical evaluation of Pharmacovigilance data and Signal Detection in order to carry out Risk-Benefit assessments.
- Preparation of Periodic Safety Update Reports (PSURs) and submission to Health Authorities.
- Construction and maintenance of archiving system for PSURs
Risk Management System (RMS)/Risk Evaluation and Mitigation Strategy (REMS), includes
- Preparation and submission of RMP& REMS
- Preparation, translation & submission to HAs of Dear Health Care Professional Letters
- Crisis Management System
Audits /Inspections in Pharmacovigilance
- Training on audits and inspections.
- Performing Audits.
- Preparation for Inspections.
- Consulting on Audit and Inspection reports.
Medical device incidents and reporting, including
- Reception of cases from literature reviewing, healthcare professionals, clinical trials, consumers and Health Authorities
- Trend tracking on events database
- Preparation and submission of Periodic Summary/Trend Reports
- Maintenance of archiving system for Incidents and Periodic Summary/Trend Reports
- Creation, Quality check and Submission of xEVPRM
- Performing MedDRA coding of Indications
- xEVMPD submission tracking and compliance data sheet
- Archival of documents
Addendum of Clinical Overview/Non-Clinical Overview
- Literature search of Clinical and Post-marketing studies.
- Analysis of studies for updating the product’s safety and efficacy profile
Medical Information System
- 24X7 calling services
- Effective management of Medical inquires, Product Quality complaints and Adverse events reported by consumer/HCP/lawyer/Nurse etc.
- Quick turnaround time for responding unique enquires
- Record the nature of the information received and requested
- Proper follow up management for all calls (MI, PQs & AEs)
- Frequently Asked Question (FAQ) maintenance for effective response for all inquires
- Compliant with applicable local and international data protection requirements
Safety Data Exchange Agreements (SDEA)
- Drafting, review and updating of safety agreements for the exchange of information (Safety Data Exchange Agreements - SDEA)
- SDEA compliance
- Audits of Business Partners & Support in inspection as required
PV Team Qualifications & Professional Experience
The Pharmacovigilance department has been engaged with product safety for more than sixty two years of combined experience. The team has strong academic background and achieved targeted expertise while meeting short timelines of implementation of projects and efficient pathways of communication. Good communication with clients and the Health Authorities, considering it as one of the pillars of effective work. The profound experience acquired by the team in all aspects of Pharmacovigilance which is demonstrated in a wide range of project types for our clients. Expert team also guarantees high quality Safety services based on the thorough knowledge of the legislation in all territories where performs services along with excellent team work.