Partnering & Outsourcing Editorial

  1. 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.

  2. 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. 

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Traditional Trials Are Dead – Virtual Trials Are The Future 9/3/2021

    It’s no secret that decentralized clinical trials, also known as virtual trials, are one of the hottest technology trends in the clinical space. Although this trial model has been touted by vendors for many years, it took the emergence of the COVID-19 pandemic in 2020 to get many companies scrambling to implement the new approach.

  9. What Risk-Based Oversight Of GxP Vendors Is & Is Not In Clinical Trials 9/2/2021

    Some pharmaceutical companies still have a notion that delegating responsibility for a clinical trial to a vendor is a way to transfer risks related to the delegated duties and functions. Nothing is further from the truth. This article examines what is vendor oversight in the context of ICH's GCP (R2) guideline.

  10. A Stem Cell Company Overcomes The Challenges Of International Trials 8/26/2021

    Performing global trials presents challenges that drug developers do not face in the U.S. Those challenges need to be considered and addressed in the planning process. Jim Joffrion, senior director of clinical development and operations for Athersys, discusses the challenges and the importance of the CRO selection process.