Drug Safety and Pharmacovigilance

Focusing on Quality in Global Drug Safety and Pharmacovigilance Services

Our safety and pharmacovigilance teams support clinical trial and post-marketing safety surveillance across the globe. With patient safety as the critical component in product development, our quality focus aligns us to partner with our customers to provide both standalone and integrated services throughout the life cycle of a product.

What sets us apart is our people: highly qualified drug safety scientists and skilled healthcare professionals with experience in direct patient care, industry-specific pharmacovigilance services and a deep knowledge of regulatory legislation and dedication to providing quality safety services.

Pharmacovigilance: Risk Mitigation for Your Compound

Mitigating risk is a critical component to a compound’s success during the development process and into commercialization. To meet the increasingly complex and diverse global regulatory requirements, we offer a comprehensive suite of pre- and post-authorization services designed to ensure safety while focusing on the rapid approval of your compound and pharmacovigilance monitoring thereafter.

Our quality driven processes are monitored by licensed healthcare professionals (e.g. registered nurses, physicians and pharmacists) who are trained to effectively assess, analyze and evaluate the emerging safety profile of your compound with an exceptional level of quality and compliance.

• Customized Safety Surveillance
• Safety Narrative Writing
• Safety Signal Management
• Aggregate Report Management
• Adverse Event & Product Complaint Management
• Individual Case Reporting
• Call Center Function
• Safety Database Services
• Literature Monitoring and Media Monitoring Search
• Clinical Adjudication Committee Management
• Development of Adjudication Materials
• Eudravigilance Reporting

We manage your safety and pharmacovigilance needs at any stage of product/device development to ensure quality and compliance:

• Clinical trial safety: Phase I-IV, from data entry to case closure, full processing, including expedited/periodic reporting
• Post-marketing safety: AE case processing, reporting, signal detection, U.S.-based call center, literature search and review, product complaints, EU QPPV and Litigation case processing
• Safety regulatory submissions: Dedicated subject matter experts in safety regulatory legislation and submissions
• Safety physicians: We have dedicated/trained physicians in all aspects of the life cycle of safety and pharmacovigilance
• Safety database: Dedicated support team with expertise in working both in customer and in-house safety database 

British BioMedicine Clinical Trials (BBMCT)

Drug Safety and Pharmacovigilance Services

Our Clinical Safety, Clinical Endpoint Adjudication, and Postmarketing Safety teams offer global capabilities with offices and personnel in the United States and the European Union (EU).

Clinical Safety Services Include the Following:

• Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects, and other significant safety events
• Safety narrative writing including physician review
• Coding (MedDRA, WHO Drug) of adverse event information
• Assessment and evaluation of reportability and submission of reportable events to global regulatory authorities
• EudraVigilance reporting and e-reporting in the EU
• Experienced certified users of EudraVigilance
• Provide expertise on safety-specific national regulatory requirements in many countries worldwide
• Preparation and submission of annual safety reports, six monthly line listings, and periodic reports to global regulatory authorities
• Custom safety surveillance including adverse event and laboratory data review and trend analysis

Postmarketing Safety Services Include the Following:

• Adverse Event (AE) and Product Complaint (PC) management
• Individual case reporting and global call center function
• Safety database services
• Global literature and media monitoring process that includes search strategy and review
• Safety signal detection and aggregate report management
• Region-specific pharmacovigilance management such as:
  • Maintenance of a certified pharmacovigilance system (i.e. PSMF) for pharmaceutical companies in the EU
  • European Union-qualified person for pharmacovigilance (QPPV)
  • Risk management plan development and maintenance
  • In-country pharmacovigilance services (including local literature surveillance and national contact persons)
  • EudraVigilance profile management