Service Types
Clinical Study Safety
We can assist with your clinical trial safety processes, from the design and setup of safety procedures, to the creation and review of Serious Adverse Event narratives.
Wainwright Associates can help with your clinical trial safety processes,we have experience in the design and implementation of safety procedures, creation and review of Serious Adverse Event narratives, reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) to the national Competent Authorities and Ethics Committees and the creation and submission of Annual Safety Reports.
In addition, we can advise on or create safety updates to Investigator Brochures and Investigational Medicinal Product Dossiers (IMPDs) or create bespoke safety reviews in response to regulatory authority requests.
Design and Setup
- Input into safety sections of clinical study protocols
- Setup of serious an adverse event reporting procedures
- Training of investigational Clinical Research Associates on safety procedures
- Preparation of an SAE manual for investigators
Serious Adverse Event Processing
- Receipt and assessment of SAE reports
- Reporting of SUSARs to national competent authorities, Eudravigilance , Investigators and Ethics committee
Annual Safety Report
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Preparation and submission of annual safety reports
Reconciliation Activities
- Reconciliation of cases sent/cases received
- Reconciliation of SAE database with Clinical database
Clinical Study Reports
- Input into the safety sections of Clinical Study Reports
Wainwright Service Types
Product Development Planning Regulatory Affairs Pharmacovigilance User Testing Licensing