Welcome to Clinical Leader Live – An interactive forum to discuss some of the most important technologies and trends impacting clinical trials.

Throughout the year, our Chief Editor, Ed Miseta, sits down with industry experts to discuss how sponsor companies can tackle some of today's biggest challenges they may face in managing a clinical trial. Even better, the audience gets ask questions during the presentation. Each Clinical Leader Live session is archived and can be accessed at any time by registered site users.

EDC TRANSFORMATION: MEET TODAY'S CLINICAL TRIAL NEEDS

  • EDC Transformation: Meet Today's Clinical Trial Needs

    When EDC in clinical trials began almost 30 years ago, it was revolutionary to clinical research. Since then, advances in science and technology are forcing the industry to consider new methods for collecting and using clinical trial data. The initial electronic data capture systems were not designed to store and manage the influx of clinical data we are seeing today, and frankly will not be able to support trials in the future. Further, the current global environment is shining a spotlight on antiquated systems and processes and is compelling the industry to rapidly embrace new ways of approaching clinical development, and specifically data collection.

IS PHARMA READY TO EMBRACE VIRTUAL TRIALS?

  • Is Pharma Ready To Embrace Virtual Trials?

    For years, technology vendors have pitched the benefits of virtual (decentralized) trials. Virtual trials are patient-centric and site-centric and can produce cost and efficiency benefits for sponsor companies. While adoption has been slow, the COVID-19 pandemic suddenly has companies scrambling for solutions that will protect patients and relieve the burden on sites. But are sponsors ready to embrace virtual trials?

COMMUNICATION BREAKDOWN – CROS, SITES & IMPROVING TRIAL QUALITY

  • Clinical Leader Live: Communication Breakdown – CROs, Sites & Improving Trial Quality

    Poor communication between sponsors, sites, and CROs can doom a clinical trial. Fear, clinical systems, and hierarchies can create issues that keep individuals from developing a clean and clear line of communication. When communication fails, the result is protocol deviations, trial errors, and quality issues which, in turn, will lead to time delays and higher trial costs.

WHAT IS WORKING, WHAT MORE NEEDS TO BE DONE?

  • What Is Working, What More Needs To Be Done?

    In February 2020 Clinical Leader Live presented a virtual conference on the topic of patient centricity. The goal of the third session was to hear the insights of patient groups, consultants, and sites on what is working, what isn’t, and what more needs to be done. Panelists included Jeannie Regnante, Founder and CEO of Patient3i, Jeff Kasher, President of Patients Can’t Wait, Leslie Hanrahan, SVP at Lupus Foundation of America, and Jennifer Mcnary, consultant and patient advocate.

THE PATIENT PERSPECTIVE ON CLINICAL TRIALS

  • The Patient Perspective On Clinical Trials

    No one is in a better position to discuss what is and isn't working for patients than those who have experienced clinical trials first-hand. In February 2020, Clinical Leader Live presented an interactive virtual conference examining what sponsor companies are doing to make trials more patient-centric, and what more still needs to be done. This video clip is from the second session titled "The Patient Perspective on Clinical Trials." The goal of this session was to explore how clinical trials have impacted the lives of these patients and their families, what pharma can do to (1) increase patient recruitment and retention and (2) better meet the needs of patients and caregivers in trials.

INCORPORATING THE PATIENT VOICE INTO CLINICAL TRIALS

  • Incorporating The Patient Voice Into Clinical Trials

    Every company wants to design trials that are more patient-centric and incorporate the patient voice into their trials. But how many are actually making progress? And are sponsor companies meeting the needs of their trial participants? In February 2020, Clinical Leader Live presented an interactive virtual conference examining what sponsor companies are doing to make trials more patient-centric, and what more still needs to be done. The video clip is from the first session titled "Incorporating The Patient Voice Into Clinical Trials." The goal of the first session was to discover what pharma companies were doing to hear the voice of patients.

CLINICAL TECHNOLOGY IMPLEMENTATION

  • Overcome The Challenges Of A Clinical Technology Implementation

    New technologies can offer many benefits to a clinical operations department. Those benefits can include faster, more efficient, and less costly trials. Still, the risk averse nature of many pharma companies can make them reluctant to adopt new technologies. In November 2019, Lawrence Florin, president of LBF Biopharma Consulting, provided actionable information on how to overcome the hurdles of acquiring a new technology.

CRO BENCHMARK PRICING MODELS

  • Clinical Leader Live: How Do You Implement A Benchmark Pricing Model?

    In August 2019 Clinical Leader Live was proud to feature Bari Kowal, Jonathan Cohen, and Reb Tayyabkhan of Regeneron Pharmaceuticals to discuss Developing a Benchmark Pricing Model for CROs. During the presentation, the team covered several topics, including implementing the model, the effects of company size, why the sudden interest in these models, and the feedback from CROs. In this video, the three executives discuss how you go about implementing a benchmark pricing model.

RISK BASED MONITORING

  • Clinical Leader Live: RBM: Challenges And Opportunities

    If you’re like most clinical operations professionals from a small- to mid-sized pharma and biopharm, what you have heard about RBM has left you with more questions than answers. Jennifer Newman is the Global Project Leader for Regulatory Affairs and Clinical Operations at Celldex Therapeutics. Jennifer's experience with RBM stems from having been part of the first team to implement RBM in a large-scale study.

Ed Miseta

Ed Miseta



Ed Miseta is chief editor for the website Clinical Leader, executive editor for Life Science Leader magazine, conference chair for Clinical Leader Forum, and host of Clinical Leader Live. Ed studied Business Economics at The Pennsylvania State University and also holds a Master’s degree in Business Administration. Ed has been a writer for more than 12 years and has been covering clinical research since January 2013. Ed spent 10 years in banking and investments and also taught economics at Penn State for 8 years. In his current position, Ed interviews clinical executives from pharmaceutical and biotech companies and shares their insights with readers. His primary focus is on best practices, challenges faced and overcome, clinical trends, partnering, and implementing new technologies. He has also moderated numerous speaker panels at industry conferences and trade shows.