Unfortunately, whether you've chosen the right clinical research organization (CRO) isn't always obvious until contracts are signed and patients are enrolled. In 2022, basic industry standard steps are being skipped left and right. Here are 6 win-win suggestions to incorporate into your vendor selection strategy/
Penelope Przekop is a is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.
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In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019. More than ever, we see what I call a stick-figure pharma company (just the bones) utilizing vendors to execute as many of the required drug development processes as they possibly can. In fact, it’s not surprising to see a company using multiple vendors for the same process, such as regulatory reporting of expedited adverse event cases, investigator site monitoring, multiple types of auditing, and manufacturing. In my consulting work, I meet and interview numerous pharma employees at all levels who struggle when asked to explain how their stick-figure company connects with all the good clinical practice (GCP) and good pharmacovigilance (GVP) practice vendors in play.
Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019. More than ever, we see what I call a stick-figure pharma company (just the bones) utilizing vendors to execute as many of the required drug development processes as they possibly can. In fact, it’s not surprising to see a company using multiple vendors for the same process, such as regulatory reporting of expedited adverse event cases, investigator site monitoring, multiple types of auditing, and manufacturing. In my consulting work, I meet and interview numerous pharma employees at all levels who struggle when asked to explain how their stick-figure company connects with all the good clinical practice (GCP) and good pharmacovigilance (GVP) practice vendors in play.
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.