Drug safety / Pharmacovigilance
Pharmacovigilance
RAY-CRO is offering end-to-end solutions in Pharmacovigilance. We offer an extensive variety of services in Safety and Risk Management which includes state of the art call centers, case preparing and processing, total safety periodic reports, signal detection and risk administration and management, and counseling all in support of our customers.
We offer our services in MENA and Gulf Regions. We are committed to patient safety and are ready to collaborate with clients to meet the increasingly complex regulatory requirements in pharmacovigilance. We are compliant with local and international regulations as follows:
We offer our services in MENA and Gulf Regions. We are committed to patient safety and are ready to collaborate with clients to meet the increasingly complex regulatory requirements in pharmacovigilance. We are compliant with local and international regulations as follows:
Contract QPPV:
- 24/7 Legal Safety Representative Services
- Main or backup qualified person for pharmacovigilance with medical backgrounds
- Available for short or long-term contracts
- Cost-effective solutions for small and medium sized companies
Detailed Description of the Pharmacovigilance Systems:
- Development of customized PSMF/PSSF specifically for your company
- Assistance with responses to regulatory enquiries until final approval
Standard Operating Procedures (SOPs):
- Designing all safety-relevant SOPs specifically for your company and in compliance with all regulations and quality standards.
- Regular update either periodically or upon request in case of change in procedures or regulations.
- Management of Spontaneous Reports
- Management of Pharmacovigilance Data/ Adverse Reactions from solicited sources
- Safety Database Availability and Generation of E2B reports which is a flexible, efficient, and cost-effective way to centralize all your safety data.
- Data Entry and MedDRA coding
- Case Processing
- Narrative writing and Medical Review
- Product Quality Complaints Management.
- Successful submissions of ICSRs as per Regulatory Timelines
- SAE reconciliations
- 24/7 AE Call center
- Follow up of ICSRs
- 100% Quality control of all ICSR including medical QC.
- Medical evaluation of Pharmacovigilance data and Signal Detection in order to carry out the Risk – Benefit assessment.
Literature Search and Review:
- Global literature database search strategy and review in support of
- Individual case safety report detection
- Aggregate safety report development
- Signal management
- Review and abstracts and articles
- Full text articles procurement and translation
- Adhoc or customized literature searches to meet specific needs
Risk Management Plan:
- Authoring and preparation of RMPs according to Regulatory Regulations
- Advice on responses to regulatory enquires
- Help & Support with preparation of Educational Materials and other Risk Minimization Plans.
- Help & Support with Survey and testing as a measure of effectiveness of RMP
Safety Aggregate Reporting:
- Writing PBRERs/PSURs in accordance with the Regulatory Regulations
- Production of DSURs (According to ICH E2F) and Annual Safety Reports from Clinical Trials
- Writing of Addendum of Clinical Overview in accordance to Regulatory Regulations
- Generation of Listings
- Regulatory report submission to appropriate reporting
Ad hoc Analysis:
- Urgent requests from regulatory authorities
- Targeted pharmacovigilance signal evaluation
- Advice on data sources, protocols and interpretations
Training:
- Tailored-made for your pharmacovigilance specialists, associates, or managers
- Training of medical and sales representatives
- Training of Health Care professionals
- Review & manage Compliance metrics for ADR reporting to regulatory authorities.
- Provide Audits to make sure your system is fully compliant with the latest Regulatory Requirements
- Develop & Implement Quality Management System (QMS).
- Support & Prepare for Inspection readiness & business partner and external audits.
- PV System and Processes Gap detection and management
- Identify and Prioritize improvements & CAPA support for closure of inspection findings.
Licensing agreements:
- We are able to prepare and improve existing safety data exchange agreements for the exchange of safety data between you and your licensing partners.
