'RAY is an outsourcing service provider specialized in the Clinical Development Process. They provides outsourcing services to the pharmaceutical and biotech industries, supports international CROs in co-development when needed, and also academic studies or medical device trials. RAY provides high quality clinical research strategy and management services from early-phases through post-marketing clinical trials (Phase II-IV) in addition to clinical surveys and registries.
|RAY "Contract Research Organization|
|Number of employees||51-200|
- Clinical Operations
- Regulatory Consulting
- Data Management/Biostatistics
- Medical Writing
- Flexible Resource Model
- Quality Assurance
- Drug Safety/ Pharmacovigilance
Drug safety / Pharmacovigilance
RAY provide all Pharmacovigilance support compliant with local and international regulations, as listed: 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
Processing Individual Case Safety Reports (ICSR):
- Handling ICSRs
- Follow-up of ICSR
- Medical evaluation of Pharmacovigilance data and Signal Detection in order to carry out the Risk – Benefit assessment.
- Pre-inspection audits to make sure your system is fully compliant with the latest regulatory requirements
- Assistance during the inspection processes
- Dealing with critical findings
- Measuring regulatory compliance: Monitoring and documenting the compliance of case-reporting to regulatory authorities.
Risk Management Plan:
- Pre-submission development for new applications, including Advanced Therapies
- Risk Management System (RMS), including the writing of Risk Management Plan (RMP) and the preparation of material for Risk Minimisation Activities.
- Advice on responses to regulatory enquires
Detailed Description of the Pharmacovigilance System (DDPS):
- Development of a new DDPS
- Assistance with responses to regulatory enquires
- Writing PSURs in accordance with the EU Good Pharmacovigilance Practices (GVP)
- PSUR/Supplementary reports according to ICH/Vol. 9
- Production of DSURs (According to ICH E2F)
- Peer review of DSURs and Annual Safety Reports from Clinical Trials
- Advice and assistance for both data analysis and presentation
Ad hoc Analysis:
- Urgent requests from regulatory authorities
- Targeted pharmacovigilance signal evaluation
- Advice on data sources, protocols and interpretations
Standard Operating Procedures (SOPs):
- Designing all safety-relevant SOPs specifically for your company and in compliance with all regulations and quality standards.
- Tailored-made for your pharmacovigilance specialists, associates, or managers
- Training of medical and sales representatives
- For the safety assessment of marketed products, the use of a specialized PV database is recommended to support ICSR analyses, reporting and archiving
- Providing clients with access to a validated E2B-compliant database which will be a flexible, efficient, and cost-effective way to centralize all your safety data.
- Management of Pharmacovigilance Data/ Adverse Reactions, during clinical trials and post-marketing
- MedDRA coding (personnel trained in MedDRA)
- Processing safety data
- International and Local Literature review for identification of published AEs.
- Local literature reviews and monitoring
- We are able to prepare and improve existing safety data exchange agreements for the exchange of safety data between you and your licensing partners.
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