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Home > Our Services > Clinical Trial Safety Support

Clinical Trial Safety Support

Confidence Beyond Compliance

Clinical trials play a crucial part in any clinical development program. As well as gaining information on a product’s efficacy, they also have a similarly important role in furnishing information on safety. The process for the gathering and reporting of the trial data must conform to regulatory requirements.

PharmaLex offers services for commercial and non-commercial sponsors to fulfil their safety reporting requirements.

We have many years’ experience in developing robust clinical study safety processes. We can design and implement safety procedures, management of Serious Adverse Event (SAE) including narrative writing and data entry in database, codifying event terms according to MedDRA, as well as concomitant medication with the World Health Organization (WHO) drug dictionary, prepare and send of follow-up requests, expectedness assessment of Serious Adverse Reactions (SARs), complete standard reporting forms (CIOMS I, Medwatch), unblinding, report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the National Competent Authorities (NCAs), Ethics Committees (ECs), Institutional Review Boards (IRBs), and investigators, as well as prepare and submit Development Safety Update Reports (DSURs). In addition, we can advise on or redact the safety sections for Investigator Brochures (IBs) updates and Investigational Medicinal Product Dossiers (IMPDs) or create bespoke safety reviews in response to regulatory authority requests.

Related News

BREXIT: Clinical Trials - Key changes
BREXIT: Clinical Trials - Key changes
3rd September 2020
Clinical trials in the post Brexit Europe
Clinical trials in the post Brexit Europe
24th August 2020
FDA Guidance: Conduct of Clinical Trials during COVID-19
FDA Guidance: Conduct of Clinical Trials during COVID-19
6th May 2020

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  • Clinical Trial Applications

What our clients say

In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.

PharmaLex Team Thomas
Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLex

Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected

Small US Biopharmaceutical Company
Sr Director Regulatory Affairs CMC

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PharmaLex. Confidence beyond compliance.

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