New Investigator Updates need to be made in the clinical study protocol and kept up to date to with the FDA. And, with more than 32,000 principal investigators globally, according to Applied Clinical Trials, these updates can occur more often than many clinical trial...

For veterans, trauma often persists even after their military service has ended; this trauma can overshadow a veteran's life, family, and future. Post-Traumatic Stress Disorder, or PTSD, is a result of carrying this trauma; PTSD is a debilitating condition that leads...

Plain language protocol synopsis (PLPS) is an important part in informing patients from the start of their clinical trial experience. On January 21, 2022, the European Medicines Agency (EMA) launched a new clinical trials website, Clinical Trials Information System...

It would be relatively easy if biopharmaceutical manufacturers could develop a perfect process one time and then rely on it to deliver the same high-quality products to all patients in all future scenarios; yet, changes in processes and sites are often necessary to...

Computerised Systems and Electronic Data in Clinical Trials play critical roles in data management, analysis, and reporting. And the systems used in clinical trials have evolved rapidly in recent years from electronic Case Report Forms (eCRF) and electronic Patient...

Corrective Action and Preventive Action (CAPA) is a process which investigates and solves identified issues by evaluating the causes and taking corrective action to resolve immediate issues. To be ISO 9001 and ISO14001 certified, companies must have a Corrective...

Psychedelic drug development is quickly becoming a new frontier in the pharmaceutical industry. On June 23, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance document outlining important considerations for researchers and drug sponsors...

There are more than 2,800 CRO’s according to IBISWorld and choosing the right partner can be a difficult choice for clinical trial sponsors looking for the right data management resources. Current and upcoming pipeline projects are critical, and it’s hard to just...

With the initial release of the Clinical Trial Information System (CTIS) in January 2022, a digital space was created for the implementation of the EU Clinical Trials Regulation (EU CTR) 536/2014, the law governing the conduct of clinical trials in the EU. A period of...