Podcast

Clinical Research: Phase 1 - Phase 4

PREMIER VOICES #15: Enhancing Clinical Trial Accessibility – Bringing Oncology Trials to Patients

Premier Research · Premier Voices #15: Bringing the Trial to the Patient In recent years, we have seen a shift toward decentralized and hybrid clinical studies that help bring clinical trials to patients and reduce the burden of study participation. COVID-19 accelerated this shift, increasing emphasis on patient access, safety, and engagement. Now, proactively incorporating...

Clinical Research: Phase 1 - Phase 4

PREMIER VOICES #13: Early-Phase Oncology – Emerging From the Crisis & Innovating for the Future

Featured Guests Luke Gill, B.Sc., M.Sc., MBAVice President, Oncology Luke Gill is the head of Oncology Clinical Development Services at Premier Research. He works collaboratively with biotech sponsors, the scientific community, and other stakeholders to develop and implement strategic approaches to early phase oncology development and CAGT trials. As a drug development expert, Gill has...

Study Design

PREMIER VOICES #12: Direct-to-Patient – Is This the ‘New Normal’ for Clinical Trials?

Featured Guests Andrea OchoaVice President, Global Study Start-Up Andrea Ochoa has over 19 years of clinical operations experience in a variety of roles, specializing in study start-up for the past 10 years. In her current role, she oversees Premier Research’s start-up function while providing expert advice and strategies to operationalize and navigate the complex global...

COVID-19

PREMIER VOICES #11: Statistical Considerations in the Wake of COVID-19

COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. Recognizing the issues is one thing, but figuring out where we go from here demands a new way of looking at some common challenges. In this episode, Premier Research’s Shari...

COVID-19

PREMIER VOICES #10: COVID-19 Update – How the FDA's Emergency Use Authorization Can Help Develop Therapies Faster

As we continue to face the ongoing COVID-19 health emergency, the medical community is tasked with bringing solutions to patients in an expedited and safe manner. One such opportunity is to partner with the US FDA by submitting an Emergency Use Authorization (EUA) for any products that could immediately and effectively address a health emergency....

Patient and Stakeholder Engagement

Premier Voices #8: Engaging Patients in Clinical Trials w/ Alan Thomas

Clinical research certainly has evolved over the past three decades. There are more trials crossing a broader spectrum of indications, and advances in study design and execution have dramatically changed the way drugs and medical devices are evaluated and sold. But perhaps no change has been more significant than the growth in engagement on the...

Patient and Stakeholder Engagement

Premier Voices #7: Rare Disease Advocacy & International Ataxia Day w/ Alan Thomas (Ataxia & Me)

This episode, we’re proud to share the first part of our conversation with Alan Thomas, patient advocate and founder of Ataxia & Me, ahead of International Ataxia Awareness Day on September 25. Alan talks about his personal journey with ataxia and how he first got started with patient awareness. Follow Alan and Ataxia & Me...

Medical and Regulatory Affairs

Premier Voices #6: Operationalizing the New MDR With Janet Kube (Part 2)

The European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are putting a lot of pressure on the medical device industry. These are big changes with far-reaching implications, and if there’s a common denominator among them, it can be summed up in one word: more. In this episode of Premier Voices,...

Medical and Regulatory Affairs

Premier Voices #5: Operationalizing the New MDR With Janet Kube (Part 1)

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years for...

Clinical Research: Phase 1 - Phase 4

Premier Voices #4: The Placebo Problem Part 2 With Michael Kuss

Measuring, interpreting, and mitigating placebo response is a persistent and growing challenge in analgesia clinical trials. In the conclusion of our Premier Voices podcast series on the placebo problem, Paul Mirek, Marketing Manager, and Michael Kuss, BS, Vice President, Analgesia Product Development, examine experimental trial designs, inclusion and exclusion criteria, and other approaches to managing the...