Clinical trial safety

 

Find out how Lindeq can manage the safety aspect during your clinical trial, including management of SUSARs and SARs, safety narrative writing, medical assessments and Development Safety Update Report (DSUR). 

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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.



Our team prepares well-written case narratives for your ICSRs, SUSARs, PSURs, research reports, regulatory files etc.

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



Lindeq provides coverage on medical safety management. We have protocols in place that will perform all necessary steps covering SAE and SUSAR: Receipt and acknowledgement, triage and assessment, data-entry, MedDRA coding, narrative writing, analysis with medical review, assessment and quality control. We also deliver expedited reporting to regulatory authorities as well as AE/SAE reconciliation. Our team consists of experienced medical doctors and pharmacists that can provide reliable assessments of any safety issue that might arise.

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



The Development Safety Update Report (DSUR) is the common standard for periodic reporting on drugs under development. The DSUR replaced the EU Annual Safety Report (ASR) and is accepted by the FDA as a replacement for the IND Annual Report.

The format of the DSUR is designed to show early potential safety issues. It includes the current interpretation and management of risks to exposed patients, describes changes in the product's safety profile and updates of the clinical development program.

Lindeq prepares the complete DSUR after having analysed respective data. If a PBRER or a RMP exists it will be aligned with these documents.

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



Lindeq provides review of safety relevant information of the clinical trial protocol and Investigators Brochure (IB) in order to ensure appropriate definitions of adverse events, optimise compliance from investigator and give advice on how to optimize the process of (serious) adverse event management.

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



Lindeq acts as a third party provider using the EV WEB trader for electronic submissions of SUSARs. This applies to both initial as well as follow-up reports. We manage all case reports and report them within 5/13 calendar days.

 

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



Lindeq registers the sponsor with the EudraVigilance (EV) clinical trial module. The registration is mandatory and enables the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs).

 

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

 



The Serious Adverse Events (SAE) reconciliation is done to ensure consistency between the clinical and the safety database for SAEs recorded in the same clinical trial.

 

Lindeq describes the workflow, lists all responsibilities and tasks to be performed including key conciliation data that has to be recnciled. After all checks have been taken place, the data is verified for completeness and the reconciliation is conducted.

 

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

 






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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)