| Pharmacovigilance Outsourcing: | Overview
and Benefits | > Services
Offered |
The Assured Outsourcing Service
Every project begins by developing a comprehensive understanding of
our client's needs across their entire organisation and can include
assessment of:
- Usual drug safety working practice and standard operating
procedures, including data standards and coding dictionaries
- Historical data quality, current database formats and future
needs
- In-house performance metrics and decision making hierarchy
- Product safety concerns, alerts and labeling
With this information we design a drug safety process to dovetail
with the client's requirements and communication needs using our
unique process-driven technology to facilitate team building,
deliverables and an open communication platform.
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Single Product to Entire Portfolio
Whatever the client's requirements, we can support all pharmacovigilance
tasks for single or multiple products right through to assuming responsibility
for an entire global safety obligations for the company, including:
- Spontaneous adverse events
- Post-marketing surveillance programs
- Serious AEs from Clinical Trials
- Laboratory Report Review
- Pharmacovigilance information technologies
- Risk management
- Regulatory reporting including FDA Annual Reports and Periodic Safety
Update Reports
- Consulting on design and implementation of drug safety systems,
processes and workflow management
- Product Liability Complaints handling
The Basic Safety Service
Our aim is to manage the drug safety data intake, assessment, analysis
and reporting of single country or multinational events on your marketed
products utilising our in-house drug safety expertise and process-driven
pharmacovigilance system, PV-Works.
This includes some or all of the following services:
- Data intake including initial assessment in accordance with our
own or sponsor's SOPs
- Investigation and follow-up of events with reporter and/or medical
professionals
- Assessment of:
- Completeness and accuracy
- Seriousness, severity and clinical outcome
- Expectedness / labeled status
- Specificity and temporal relationship
- Causality
- Reporting requirements
- Regular tracking and status updates
- Annual summary of activity
The Expanded Safety Service
Alone or in conjunction with the Basic Safety Service, we offer the
following services:
- Pharmacoepidemiological analysis, adverse event trending and signal
generation
- Recommendations for patient safety, product labeling and product
protection
- Liaison with regulatory authorities
- Generation of Annual Safety Reports and Periodic Safety Update
Reports (PSUR). PSURs can be generated either in line with regulatory
reporting intervals or more regularly as a basis for product review
- Consultation on safety issues
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