The accurate and timely processing and reporting of serious adverse events is a crucial element of a successful clinical trial. Sponsors must ensure that proper processes and procedures are set-up to protect clinical trial subjects/patients as well as assure timely safety reporting to research sites, ethics committees and competent regulatory authorities.   

At insuvia, we work closely with clinical trial Sponsors, CROs and sites to monitor the clinical safety of investigational products and detect any change to their risk-benefit profile, and to ultimately assure compliance against all relevant reporting requirements.

Our clinical safety processes have been specifically designed to meet the needs of smaller Sponsors and to provide them with a flexible and cost-effective full-service safety department as an outsourced solution. Alongside the central clinical safety service, we utilize our local pharmacovigilance network to support Sponsors and CROs with country-level submissions of expedited and periodic reports as well as to fulfil applicable local cross-reporting requirements.

Insuvia offers a wide range of clinical safety services, including:

  • Development of Safety Management Plans 

  • Provision of EudraVigilance (EV) Responsible Person 

  • Processing of SAEs and other Reportable Events 

  • Medical review, assessment and MedDRA coding 

  • Regulatory Reporting to regional and local authorities   

  • Narrative writing  

  • Preparation and submission of periodic safety reports 

  • Development of Medical Monitoring Plans 

  • Continuous medical support on eligibility, issues or concerns 

  • Medical review of study materials (data, listings, reports) 

  • Medical coding

  • Medical consultations

Discover more services :

Local Pharmacovigilance Outsourcing

Country-level pharmacovigilance systems and local QPPVs to assure safety compliance in individual countries.
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QPPV & Pharmacovigilance System

Global pharmacovigilance system, including all pharmacovigilance processes and activities to assure compliance and patient safety.
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Marketing Authorization Applications

Regulatory strategy and marketing authorization services aimed to achieve fast and smooth regulatory approvals.
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