Pharmacovigilance Services
 Take Advantage of our Skills
Sentrx offers a variety of pharmacovigilance consulting services, providing assistance to your company when and where it’s needed.
Pharmacovigilance Assessments and Audits
Sentrx assesses drug safety strategy, infrastructure, personnel, operations, processes and systems and delivers specific recommendations for improvement.
Pharmacovigilance Data Audit
Sentrx performs an end-to-end quality review of drug safety data integrity, beginning with the investigator site or spontaneous reporter through company intake processes and database entries to regulatory agency reports.
Pharmacovigilance Training
Sentrx develops and delivers customized adverse event reporting and safety database training courses to drug safety or sales staff.
Literature Review
Sentrx performs a regular search of the literature using the Custom
Information Services of Thomson Scientific, a business of The Thomson
Corporation and processes any adverse events found. Thomson Scientific
searches more than 10,800 journals within their Web of Science® against
client-specific profiles to retrieve relevant information, which is indexed
according to client specifications.
Product Recall Services
Sentrx manages data intake, assessment and reporting of adverse event and product complaints resulting from the recall or withdrawal of a pharmaceutical or medical device product.
Product Litigation Support
Sentrx performs thorough investigation and documentation of drug safety cases to defend a product in litigation.
Periodic Report/PSUR Preparation
Sentrx prepares Periodic Safety Update Reports (PSURs) and other periodic reports to be submitted to the appropriate regulatory agencies. |
