Integrity and Reliability Concerns in Bioequivalence Studies: An Insight into the Synapse Labs Inspection
In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 2
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
Building Comprehensive PV Programs Around a Single Safety Database
What are the keys to building a comprehensive pharmacovigilance (PV) program? Be forward thinking, invest wisely, and question everything. It is so easy as a sponsor of a first-in-human clinical...
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FDA Issues Draft Guidance on Psychedelic Drug Development
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance on the development of psychedelic drugs.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...
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...
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...
Clinical Research Solutions
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,...
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...
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...