KlinEra is proficient of working on all major safety databases available in the market (Eg Oracle Argus Safety Database and ArisG Safety Database) and successfully assisted clients in reviewing and selecting system based on changed safety data requirements.
KlinEra has experienced staff who are trained on end to end case processing, safety risk management, literature search activities, regulatory intelligence services and signal management. Based on the Service level agreements (SLA), KlinEra safety team focuses on the below key performance indicators that ensures success in managing each project portfolio.
AEs (Adverse events) reports:
Case processing and reporting:
Literature Review Specialist:
Literature screening:
Regulatory and Investigator site submission of ICSR’s, DSUR/PSUR and line listings:
Signal Detection and Signal Management:
Aggregate Reporting:
Medical Monitoring Expertise:
KE Medical Monitoring team has experience in assisting trials for the following indications:
KlinEra Operational Expertise in Pharmacovigilance and Medical Monitoring:
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