Webinars

Taking Device Clinical Development to the US & Europe

Thursday, April 28 2:00 p.m. AEST Medical devices play an increasingly critical role in the health and quality of life of millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences...

IVDR Survival Guide: Know The 4 Main Challenges And How To Overcome Them

With the positive aim of increasing patient safety, the In Vitro Diagnostic Regulation (IVDR) has fundamentally changed the way in vitro diagnostics (IVD) are regulated in the EU. The depth of expectations for review and documentation have increased substantially. As a result, IVD sponsors are having to adapt to a daunting set of regulatory updates.This...

The 505(b)(2) Pathway: Getting to the Clinic Faster

Wednesday, April 206:30 pm IST | 9:00 a.m. EDT | 1:00 p.m. GMT Use of the 505(b)(2) regulatory pathway has seen rapid growth as drug developers seek to avoid unnecessary duplication of research and get products to market faster. By making it possible to postpone or outright eliminate trial phases, the 505(b)(2) pathway offers a...

Designing and Conducting Decentralized Dermatology Trials

Conducting rigorous assessments and obtaining the highest-quality data are essential to dermatology clinical research. Traditional clinical trial designs can pose obstacles for patients with busy work and personal lives, especially if they live far from a study site. Decentralized trials open opportunities for broader patient populations, increasingly important as competition for patients grows with the...

Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide: Know the 4 Main Challenges and How to Overcome Them

March 23, 2022 | 10:00 AM EST / 7:00 AM PST / 3:00 PM GMT With the positive aim of increasing patient safety, the In Vitro Diagnostic Regulation (IVDR) has fundamentally changed the way in vitro diagnostics (IVD) are regulated in the EU. The depth of expectations for review and documentation have increased substantially. As...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes (Australia)

March 3, 2022 | 2:00pm AEDT Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually...

Study Design Webinar Series: From Brilliant Idea To Life-Changing Reality

Our clinical trial experts dive into three topics that will help get you started on the right path to a successful trial. With Premier Research, every aspect of your clinical trial, from design and investigators to sites and patient selection are customized for your indication – including preferential regulatory pathways and other strategies for successful...

Clinical Research: Phase 1 - Phase 4

Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many Phase 2 trials fail to...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors

Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually placed predominately on recruitment and not on patient...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes

February 24, 2022 | 10:00am EST Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually...