Clinical Guest Contributors

1. Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product’s Labeling & Shipment 10/14/2021

   When you assess other industries and companies like Amazon, Tesla, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some clinical trials operatives may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those, I say: that's an excuse. 

2. Co-Creating With Patients: The New Guide To Expanded Access 10/12/2021

   Recently, Janssen Pharmaceutical Companies had the privilege of working with patients and advocacy groups to co-create a resource about expanded access for patients and caregivers. This article shares that story and describes how patients will benefit from the resource.

3. 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.

4. 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.

5. Decentralized Clinical Trials: Does Your Strategy Include These Facets? 9/30/2021

   Decentralized clinical trials have increased in response to the COVID-19 pandemic, yet this may be due to a convergence of two factors already in play: our reliance on the use of digital health technologies and a move by the FDA and industry toward patient-focused, real-world clinical trials that leverage the technological advances already available.

6. 3 Strategies To Engage With Patient Advocacy Organizations 9/28/2021

   Patient communities can offer extremely valuable insights to help ensure the success of your clinical development program. Larger companies have a corporate function with professionals who are well versed in engaging these groups, but how do small companies take that first step to introduce their company to a new patient community? Here are 3 successful strategies.

7. Best Practices for Risk Assessment of GxP Vendors and Inspection Readiness 9/21/2021

   Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

8. Cell And Gene Therapies: Solving Six Challenges 9/20/2021

   This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

9. 6 Key Steps For Cell Therapy Clinical Development Success 9/14/2021

   While the simplest option for a small or emerging biotech is to outsource protocol and clinical development to a consultant or CRO, a disengaged or absent sponsor is unlikely to have its objectives realized. Prior to engaging with a consultant or CRO, you can take these six steps that are likely to leave both parties engaged in the clinical development process.

10. What Can Clinical Leaders Do To Tackle The Global Women’s Health Gap? 9/9/2021

    Nearly 300,000 women die every year from preventable causes related to pregnancy and childbirth. Postpartum hemorrhage is the leading cause of maternal death globally — and in the US, it's on the rise. Uterine fibroids disproportionately impact Black women and are a leading cause of hysterectomies. We must drive a concerted, ecosystem-wide effort that scales up clinical research for women.