We recently held the second of our presentation series “Surviving the Transition to Clinical Trials” at JLABS in Toronto. More than 45 people, representing biotech, pharma, and medical device companies, came to find out how to take their innovative ideas from the lab to the…
The 10th Annual Outsourcing in Clinical Trials West Coast Conference covered a wide range of subjects. New this year were three tracks on clinical innovation, early phase development, and data-driven approaches, and attendees heard the latest on artificial intelligence and blockchain technology. Whiteboard sessions, panel…
I had the opportunity to attend the SCOPE Summit for Clinical Ops Executives in Orlando, February 12-15. It’s been a few years since I last attended a SCOPE Summit, so it was interesting to see that some clinical research issues have evolved, while others persist…
You’ve done all the background work. You’ve navigated the complex U.S. regulatory environment and achieved investigational new drug approval. You’ve secured investors and assembled your core team. You are now preparing for the next big milestone for your burgeoning biopharmaceutical company – entering the clinic.…
Planning to export an ancillary supply or a medical device? Get ready for some bureaucratic red tape. Country governments take compliance with their import and export laws and regulations seriously. If a violation occurs, the in-country importer of record could find itself facing fines, penalties,…