Late Phase-PPA (Peri-
and Post-Approval)
Details, details, details. Even the smallest one can make a big difference, and that’s what we’re all about in Late Phase-PPA (Peri- and Post-Approval). Our team conducts medical affairs research that ensures every last detail is nailed down, every population is included, and every gap is filled regarding planned labels and indications during the last phases before a drug goes to market. Much of our peri- and post-approval research is non-interventional in nature. Some study designs include no on-site monitoring, others may include on-site visits, and still others may follow a more formal reduced Source Data Verification monitoring model. Regardless of the project, Late Phase-PPD offers real opportunities to make a positive difference.
best-fit characteristics
Late Phase-PPA is the ideal career area if you’re a CRA interested in working in a more diverse environment. We welcome those who seek different study designs and monitoring approaches, have a commitment to collecting real-world evidence, and desire to gain experience in many indications and/or therapy areas.
Your attributes and experience
To succeed within Late Phase-PPD, you’ll need a basic knowledge of and interest in peri- and post-approval studies types. These include phase IIIb/IV interventional, observational, registry, pregnancy/infant registry, Health Economics and Outcome Research (HEOR), Patient Reported Outcomes (PRO), Chart Review, Expanded Access, Extended Access, Compassionate Use, and others. We’ll expect general clinical experience typically associated with the CRA role, the ability to collaborate and create relationships with many different stakeholders, such as sponsor medical science liaisons/local medical affairs teams, and other PPD team members, even as the majority of your interactions are conducted remotely by phone or email.
Skills you can attain here
Within Late Phase-PPA, you’ll have the opportunity to build relationships with multiple stakeholders when all communication is remote. In addition, you’ll earn to recognize and escalate site issues related to consenting issues, lack of data entry and query resolution, and possible mis-reporting of SAEs.