Promoting Diversity, Equity, and Inclusion (DEI) in Clinical Trials

Health is much more than numbers, medications, or a clinical diagnosis. A person’s health is affected by their environment and their lived experiences. 

An Introduction to Clinical Evaluation Reports for Medical Writers

Before a medical device is marketed to the public, it needs to undergo a rigorous analysis to ensure that it is safe and effective. 

Devices sold in the European Union need to meet the standards published by the International Medical Device Regulators Forum (IMDRF), a group of regulators from around the world. 

Maximizing the Value of Regulatory Medical Writing

Are you a regulatory medical writer who is concerned about proving your mettle?

Regulatory medical writers play a critical role in the drug development and approval processes. Yet their role is often misunderstood and undervalued.

A Critical Link: What Medical Communicators Should Know about Preparing AMCP Dossiers

What role do medical communicators play in the world of health care reimbursement? 

In the United States, health care reimbursement and access is a complex process that involves multiple parties known as payers (or payors): insurers, national health entities, and other decision-makers. The goal is to provide effective health care to patients while also weighing the costs of drugs, devices, and procedures in order to develop plans for formularies.

Medical Communicators and Medical Advisory Board Meetings

Pharmaceutical companies look to medical advisory boards to help shape the big‑picture aspects of their work. Are their products benefiting patients and health care professionals? Can they do a better job of meeting the needs of patients?

Package Inserts: A Medical Writer’s Primer

Medical writers can find vast amounts of information about prescription drugs and biologics from a variety of resources, such as scientific publications, electronic databases, and free online content from sites such as drugs.com.

A challenge for medical writing professionals is sorting through these resources to find information that is accurate and acceptable to use as a reference source when writing content that will ultimately go through medical‑legal review.