Fact Sheet or Brochure

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...