Patient-Centric Trials: How Using Technology Can Enhance the Participant Experience Traditionally, clinical trials emphasized scientific data collection and adherence to strict regulatory requirements. This focus on collecting standardized data provided helpful information regarding drug and therapeutic development but left…

3 Tips for Improving Your Clinical Trial Site Selection Process Selecting a site (or sites) to host your next clinical trial is crucial to your success, but the process is often time-consuming and filled with obstacles. Studies show that…

5 Areas Where CROs Are Making a Difference in Rare Disease Research Rare disease research is becoming increasingly crucial for the biopharmaceutical industry. Several factors have contributed to this rise, including favorable government policies, extended exclusivity periods, and lower…

5 Tips for Embracing eConsent Adoption While Keeping Patients at Top of Mind Electronic informed consent (eConsent) technologies have been around for nearly 20 years, but they’ve skyrocketed in popularity since the COVID-19 pandemic. With so many companies adopting…

In April, The U.S. Food and Drug Administration (FDA) released three draft guidance documents focused on increasing participation and diversity in oncology clinical trials. The proposed guidance focuses on three areas ––– washout periods and concomitant medicines, patient’s performance…

Pro Tips for Creating a Successful Informed Consent Form (ICF) The informed consent form (ICF) is one of the most crucial documents sponsors draft for clinical trials. For many potential enrollees, the ICF is their first introduction to clinical…

What You Need to Know About the FDA and OHRP’s Joint Draft Guidance on Informed Consent in Clinical Trials  All FDA-regulated clinical investigations of drugs, medical devices, and biologics require participants to give informed consent. Knowing a therapeutic’s potential…

Rare disease research has come a long way thanks in part to the passage of the Orphan Drug Act (ODA) of 1983. In the 40 years since, the biopharmaceutical industry has steadily increased its research and development efforts. Consider…

The last 12 months have been challenging for many in the biopharmaceutical space. Consider that industry layoffs increased 57% in 2023 compared to 2022. It’s amazing how quickly things change. During the COVID-19 pandemic, many of the same companies…

In October 2023, the FDA issued draft guidance on Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities. The document explains how the FDA operates its remote evaluation program and lays out expectations for the industry.  Although remote…