Partnering & Outsourcing Editorial
-
Your New 6-Step Approach For CRO Selection In 2022
2/15/2022
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.
-
Essential Elements Of Clinical Trial Sponsor Oversight For Mitigating Scientific Misconduct & Fraud
2/10/2022
Sponsor companies are responsible for the protection of human subjects and the quality and integrity of their data when it comes to the conduct of clinical investigations. This responsibility sounds daunting, but this article shares how to break down key elements of CRO oversight in a holistic way.
-
Is A Preferred Provider Agreement Right For You?
1/14/2022
A preferred provider and/or a strategic provider is a vendor company, often a CRO or other specialty service provider, that has achieved priority status in the awarding of contracts by pharma/biotech companies. With the growing complexity of clinical research, the preferred provider is gaining popularity with many companies. Clinical Leader's Chief Editor, Ed Miseta, talks with Jennifer Johnson of UCB in this Q&A.
-
How Biopharmas And CROs Can Create Value In Decentralized Global Trials
11/2/2021
The need for biopharma execs to effectively engage CROs in decentralized clinical trials will only increase in the years to come. This article examines the results of a recent Ernst & Young (EY) study and also offers some recommendations for sponsors and CROs to be more effective with decentralized trials.
-
Best Practices For Sourcing & Outsourcing In Clinical Operations
10/21/2021
Transformation of clinical operations across processes, people, and technology has become a strategic priority, as nearly 70% of R&D spend is on clinical trials. Since a significant portion of clinical trials are outsourced to external partners, it is imperative that life sciences companies have a dependable set of global and regional external partnerships that are flexible and scalable.
-
From Fusion Energy To Med Device … To Drug Developer?
10/21/2021
It’s not often you hear the CEO of a life sciences company say things like, “The big technology advancement we were waiting on was using accelerators to generate the needed neutron radiation.” Of course, not many life sciences companies have “fusion energy” listed as one of their areas of expertise. But that’s not the only thing atypical about TAE Life Sciences (TLS).
-
Why Has There Been A Shift In Power In Pharma Partnering?
10/19/2021
When it comes to partnering models in drug development, Syed Kazmi, CEO of Jubilant Therapeutics, believes there has been a dramatic shift in the thinking of pharma companies. Kazmi has worked for both pharma and biotech companies and on both the business and R&D sides of the house. That gives him a unique perspective on and appreciation for how partnering has evolved.
-
Dispelling The Misconceptions Of Conducting Clinical Trials In Russia
10/8/2021
Russia is a growing area for clinical trials. In 2018, 654 new trials were approved in Russia. Approximately 50% of those trials were initiated by multinational companies led by Novartis, Roche, Pfizer, Janssen, Abbvie, AstraZeneca, and Merck. Oncology trials led the way with 114 trials, followed by rheumatology and neurology.
-
How AstraZeneca’s Clinical Trials Procurement Team Adapted To The Pandemic’s Demands
10/7/2021
The pandemic has tested AstraZeneca’s Global Operations organization to ensure clinical trials continue. As a function, procurement plays a key role across this supply chain, with a strong emphasis on assuring supply of product on time and with solid service by third-party suppliers to respond to any shifts in demand. Here's how AstraZeneca's procurement team successfully adapted.
-
What Is Scientific Research Misconduct & Fraud In Clinical Research?
10/5/2021
What does scientific misconduct and fraud truly mean in the context of clinical research? And what are the ramifications for those at fault? This article provides an overview as well as common findings from the DOJ and FDA.