This article discusses what should be addressed to mitigate enterprise risks as they pertain to data integrity. It also lists what data-integrity compliance issues you should assess when choosing a CDMO.
This is the first of a two-part article exploring the factors creating a demand from innovator biopharmaceutical companies for continuous manufacturing facilities in the U.S. and EU. It also covers the economic and technical challenges facing CDMOs considering building API CM facilities.
The nonprofit CivicaRX continues to gain momentum, and the company’s president and CEO, Martin Van Trieste, believes it’s a business model that is “pro-competition,” and one that others throughout the biopharma industry can adapt as well.
ISR surveyed hundreds of clinical development outsourcers about what they consider important when selecting providers. To capture the increasing role that preferred provider agreements are playing in the selection process, respondents were asked about attribute importance in several scenarios.
Bari Kowal, VP and head of global clinical operations at Regeneron, says sponsors and CROs must partner to make clinical trial execution more efficient and cost-effective.
Insights for the simple things you can do to mitigate the most common patient enrollment problems that every study (with very few exceptions) will inevitably face.
ISR has observed use of Preferred Provider agreements and the proportion of outsourcing allocated to Preferred Providers increase over the past three years. Is it because PPAs are the best model for outsourced manufacturing?
Today, the success of your programs has never been more contingent upon selecting and working effectively with your service partners. This is what our annual CMO Leadership Awards are all about.
Outsourced Pharma brought together a panel of experts at sponsor companies to discuss specifically how small biopharma can compete for attention at CDMOs.