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Safety - Pharmacovigilance  FDA / EMA Regulations

We Comply with the Regulations that Apply to Us.
We Make Sure Your SAE Process Complies with the Ones that Apply to You.

eReconciliation┬« software, systems and services comply with all regulations: GxP, GAMP 5 Validation, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, ISO 27001. From the adoption of your Safety Data Reconciliation process to your FDA and EMA Safety Data Submissions, we help you cover every step from the performing of the reconciliation to the creation of the audit trail.

SAE Reconciliation: Improving Safety Data Quality, Validating Pharmacovigilance Data Management, and Reducing Risks for Patient

Streamlined by the efficiencies of eReconciliation┬« software - Serious Adverse Events Reconciliation is performed using less time, personnel and improving GxP Quality 

Endpoint Adjudication: Quality Data Management

Improve Data Management

eReconciliation® helps improve Safety data management processes. Discrepancies and inconsistencies are flagged, allowing easy correction for current and  future studies.

Endpoint Adjudication: Validated Trial Outcomes

Validate Pharmacovigilance

The clinical database is checked and cleaned throughout the study. eReconciliation allows to leverage the clinical data to improve the quality of the safety database thus validating the SAE data.

Endpoint Adjudication: Improved Patient Outcomes

Lower Patients' Risks

By improving the quality and accuracy of SAE data in both the clinical and safety databases, patient safety is increased.

Safety Data Reconciliation Regulations and Guidelines

Here are helpful links to THE FDA and EMA guidance documents that address core concerns of Pharmacovigilance and Serious Adverse Events Reconciliation.

ICH: Clinical Safety Data Management 

Clinical safety management: definitions and standards for expedited reporting: ICH Topic E2A, 27 October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

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European Commission:
Guidance on Adverse Events/ Reactions

Detailed guidance on the collection, verification, and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use: CT-3, June 2011. This detailed guidance addresses the collection, verification and reporting of adverse events and adverse reactions which occur in a clinical trial falling within the scope of Directive 2001/20/EC, i.e. a clinical trial as defined therein and performed in at least one EU Member State.

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FDA: Final Rule
Drug Safety Reporting Requirements

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, 21 CFR Parts 312 (IND studies) and 320 (BA-BE studies). September 2010, effective 28 March 2011. The final rule codifies the agency’s expectations for timely review, evaluation, and submission of relevant and useful safety information...

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FDA: Safety Reporting Requirements for INDs

FDA - Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies. Guidance for Industry and Investigators. December 2012.
This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors and investigators.

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Download Your SAE Reconciliation Handbook (16 pages)

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SAE Handbook Download

Download your FREE practical guide on how to reconcile safety data collected from various sources and stored in more than one databases.

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Clinical Safety Glossary

A list of terms and definitions related to Serious Adverse Events, adverse event data management and safety and clinical databases SAE Reconciliation.

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Computer System Validation

Ethical's eReconciliation systems, business processes and services are compliant with the appropriate regulations: GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR).

Reconciliation of Safety Data and Computer Systems' ValidationREAD MORE