Management of SAEs and SUSARs

Whether it is an initial report or a follow up report, Lindeq manages your SUSARs and SAEs during the entire process: from receipt, data entry, narrative writing, MedDRA coding, possible follow up and medical assessment to electronic reporting.

For more detailed information please contact us directly. Together we will find the best solutions to correctly target your needs.

 

Do you not have a validated safety database yet? In collaboration with the Danish pharma IT developer BaseCon Lindeq offers a safety database solution including set up, validation and maintenance.




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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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Cosmetovigilance
Full range of cosmetic product safety services for all different types of cosmetic products
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Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)