Caraka Clinical and Translational Sciences applies proven methodologies and industry-standard best practices through every stage of Pharmacovigilance:
At each of these stages, Caraka Clinical and Translational Sciences professionals pay careful attention to established business metrics and workflow to ensure efficiency, accountability, and transparency. The result is high-quality safety data that forms the basis for an accurate profile of your product’s safety.
Caraka Clinical and Translational Sciences offers a comprehensive range of case management services that can be tailored to meet your requirements and/or budget. Select only the services you require. Or, select an end-to-solution covering your entire development program from the earliest phases of clinical trials to postmarketing surveillance.
Our services include:
- Individual case safety report(ICSR) management: triage, case processing, safety review, quality review, and medical review
- Safety literature searches
- E2B case reporting and archiving
- Regulatory compliance and tracking
- Safety data exchange agreement(SDEA) maintenance and tracking
- Medical information call center(MICC) management
- Identification of data migration requirements for archiving in a single repository
- Process optimization: streamline processes and applications by defining inputs, outputs, and metrics
- Automated adverse event(AE) case receipt and review
- Automated creation of followup letter and narration
- Submission of serious reports to the regulatory authority
- Quality assurance