Clinical Research Solutions
FDA Issues Draft Guidance on Psychedelic Drug Development
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance on the development of psychedelic drugs. There has been a growing interest in using psychedelics for the treatment of...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 1
In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits. the role that independent auditors play in conducting compliance...
Clinical Research Solutions
Decentralization of Cell and Gene Therapy
Patients typically go through the same thought process when they have been diagnosed. After the relief of knowing that their ailment was correctly diagnosed, most patients want to know the path back...
Clinical Research Solutions
Clinical Trial Good Clinical Practice (GCP) Audits – Are you ready?
Good clinical practice (GCP) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human...
FDA's Concern over Diethylene Glycol (DEG) and Ethylene Glycol (EG) Contamination
Recent contamination of several drug products in India resulting in fatalities have prompted a new FDA guidance entitled "Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch...
Meet the Expert: Louise Leach
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Digital Transformation
Leveraging Veeva Vault’s TMF Bot & AI to Improve Quality and Consistency
The Trial Master File (TMF) allows an effective way to collect and manage study specific documents during a clinical trial. The TMF serves as a complete and accurate record of the trial's conduct,...
Clinical Research Solutions
Why Decentralized Clinical Trials are the Future of Clinical Research
Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinical research, offering unique benefits that challenge the traditional models. However, deciding whether to...
Meet the Expert: Jens van Wijngaarden
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
Benefits of Decentralized Clinical Trials
In recent years, the landscape of clinical trials has undergone a remarkable transformation with the emergence of decentralized clinical trials (DCTs). These innovative approaches leverage technology...
Meet the Expert: Warren Vieira
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Medical Information
Artificial Intelligence in the Medical Information Industry: Transforming Healthcare with AI and Automation
The rapid advancement of artificial intelligence (AI) technology has revolutionized various industries, including the medical information sector. One notable AI-driven tool is ChatGPT, developed by...
Meet the Expert: Ioana Panturoiu
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Meet the Expert: Kimberly Futch
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Trials in Australia: Unlocking Value for Clients
In recent years, Australia has emerged as a leading destination for conducting clinical trials, attracting pharmaceutical, biotech, medical device/diagnostic companies, and research organizations...
Medical Information
Patient and Healthcare Provider Satisfaction Surveys: Maximizing Response Rates
Customer perception and satisfaction play a pivotal role in shaping the success and reputation of pharma companies. Given the significance of these factors, it's understandable that many pharma...