Guides

Product Development

Accelerating Digital Innovation: A Checklist for Digital Therapeutic Developers

Over the past decade, the development of digital medicines has been steadily gaining momentum, with real-world data demonstrating that these approaches can help improve patient lives. The COVID-19 pandemic further propelled the digital medicines industry forward by shining a light on the need for innovative treatment options and accelerating the adoption of technologies that integrate...

Clinical Research: Phase 1 - Phase 4

Expert Guide to Decentralized Dermatology Trials: Five Strategies for Study Success

To optimize the likelihood of success, dermatology clinical trials should be designed with the patient in mind, minimizing the burden of participation and maximizing accessibility for a diverse population of qualified patients. In a development space as active as dermatology, where competition for eligible participants is intense, adopting a patient-focused approach is essential for meeting...

Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide: Understanding the IVDR Product Classification System and Complying with the New Clinical Evidence and Performance Expectations

The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...

OCT Medical Device 2022

CRO Resources Medical Device Services Planning for Quality inMedical Device Clinical Trials Best Practices for Interventional CardiovascularMedical Device Trials in Asia-Pacific Strategic Planning for Compliance with theEU Medical Device Regulation Medical Device Development:Pathways to Clearance or Approval in the U.S. and the EU Software as a Medical Device: Here’s How the Regulatory Landscape is Changing...

Clinical Research: Phase 1 - Phase 4

ASIST: Advanced Study Integrity Services Team

How has COVID-19 impacted your clinical study? Get the insights. The analysis. And the plan. The COVID-19 pandemic has altered the clinical trial landscape around the world. Keep your study on track with expert help from the Premier Research Advanced Study Integrity Services Team (ASIST). Premier developed ASIST to help biopharma companies like yours adapt...

Frequently Asked Questions for Drug & Product Development

0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 What is the 21st Century Cures Act? Legislation designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster...

Consulting

Six Things You Need to Know About Medical Devices and Cybersecurity

Concern over cybersecurity touches our lives in new ways almost daily. Today, there is growing concern over millions of people who use connected medical devices that use off-the-shelf software. Here are six things the FDA’s Center for Devices and Radiological Health wants you to know about the safety of networked medical devices: 1. Hacking of...

Consulting

A Delayed Onset Muscle Soreness (DOMS) Model for the Evaluation of Topical Analgesics

Many orally available NSAIDs are being reformulated into topical formulations for the treatment of mild to moderate soft tissue pain. The use of topical non-steroidal anti-inflammatory drugs (NSAIDs) is the preferred method for treating mild to moderate soft tissue injuries. Reducing the systemic exposure of NSAIDs should reduce the chances of gastrointestinal (GI) and cardiovascular...