The moment a new therapy succeeds in clinical trials and enters the marketplace its life becomes more complex; and the cost of failure after reaching the market is significantly heightened. With the introduction of new regulatory requirements governing post-approval pharmacovigilance, means the pressure on biopharmaceutical companies is ever increasing.
PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality integrated services across the full spectrum of the post-approval life cycle.
Our seamless execution, breadth of services, deep expertise and a highly scalable global capacity make PAREXEL a leader in Pharmacovigilance outsourcing.
Whether you are looking to partner with us for case processing support, aggregate reporting, literature searching, medical assessment, or for an end-to-end product portfolio maintenance program, PAREXEL can tailor a solution to meet your unique needs.
We have the flexible capability and global reach to support large volumes of cases (currently handling ~600,000 cases each year) and can support affiliate models for many countries.
PAREXEL has a large team of global subject matter experts who are able to review systems, processes, documentation and technology in order to conduct a detailed gap analysis to identify process improvements, efficiencies, and adapt to changing regulatory requirements. Our experts include:
Why juggle multiple providers and compromise efficiency? Let PAREXEL help you navigate through the complexity and more effectively achieve your goals.
Safety/Pharmacovigilance #1
Learn how PAREXEL® collected CRF data using a hybrid system in all countries as required. Since this was not a mandatory program in all countries the methodology had to be user friendly in order for unpaid physicians to be motivated to complete CRFs. Click here.
Safety/Pharmacovigilance #2
Learn how PAREXEL® developed an effective working relationship between sponsor HQ and affiliates in over 40 countries, with tasks being split between PAREXEL, sponsor HQ and the affiliates. Click here.
Learn about our dedicated unit of late phase specialists providing a full scope of peri/post-approval services that help our client’s collect data needed to successfully prove the value. Download here.