RAY

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'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.

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http://www.ray-cro.com
RAY "Contract Research Organization
Type Private
Industry Research
Founded 2010
Headquarters Giza ,Egypt
Number of employees 51-200


Services

  • Clinical Operations
  • Regulatory Consulting
  • Data Management/Biostatistics
  • Medical Writing
  • Training
  • 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.

Pharmacovigilance audits:

  • 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

Safety Reporting:

  • 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.

Training:

  • Tailored-made for your pharmacovigilance specialists, associates, or managers
  • Training of medical and sales representatives

PV Database:

  • 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)

Data Processing:

  • Processing safety data
  • International and Local Literature review for identification of published AEs.
  • Local literature reviews and monitoring

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.


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