On January 6, 2025, the FDA issued draft guidance titled Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The announcement recognizes that artificial intelligence (AI) is becoming more prominent in drug…

Clinical trials have become increasingly complex over the last few years. More data is available than ever, trial designs are more intricate, and there’s an increased focus on highly specialized patient populations. These factors, combined with the industry’s global…

National Institutes of Health Develops New Algorithm to Accelerate Clinical Trial Enrollment and Research Volunteer recruitment is one of the biggest challenges biopharmas face. Even the best trial designs aren’t immune. Consider that up to 85% of clinical trials…

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In April, The U.S. Food and Drug Administration (FDA) released three draft guidance documents focused on increasing participation and diversity in oncology clinical trials.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…