Cytokine Release Syndrome Cytokine release syndrome (CRS) is an inflammatory immune reaction that clinically manifests as fever, headache, joint and muscle pain in mild cases to hypotension, vascular leakage and organ failure in severe cases (Shimabukuro-Vornhagen et al., 2018). CRS is associated with a tremendous surge of cytokines, chemokines and soluble mediators which are primarily ..read more

Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic steatohepatitis (NASH) is one type of NAFLD. Individuals with obesity and type 2 diabetes appear to be at greater risk of developing NAFLD. In recent years, NASH and NAFLD have been renamed MASH (metabolic dysfunction-associated steatohepatitis) and MASLD (metabolic dysfunction-associated ..read more

aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for any clinical trial. Creating quality annotated case report forms (aCRFs) takes time and attention to detail.   So, it’s important to understand what regulatory and industry guidelines are out there, to ensure your aCRFs meet the requirements.  What are annotated CRFs?  ..read more

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. Metadata is the building blocks of your study. It’s the forms, terminologies and datasets you need to structure your study and start collecting data.  Managing clinical trial metadata can be challenging. You have to find the right content, make sure ..read more

The Inflation Reduction Act (IRA), one of the key legislative achievements the Biden-Harris administration, aims to expand benefits and reduce costs for Medicare beneficiaries. Among its provisions, the IRA introduced a significant temporary reimbursement boost for biosimilar drugs under Medicare Part B, designed to encourage their adoption.   Biosimilars, often referred to as follow-on biologics, are ..read more

The use of controlled terminology (CT) is vital to successful clinical study build. In clinical trials, CT can be referred to in several different ways, such as:    While these terms are closely related, they don’t mean exactly the same thing.  In this blog, we explore each of these terms and examine the role of controlled ..read more

Cytokine Release Syndrome Cytokine release syndrome (CRS) is an inflammatory immune reaction that clinically manifests as fever, headache, joint and muscle pain in mild cases to hypotension, vascular leakage and organ failure in severe cases (Shimabukuro-Vornhagen et al., 2018). CRS is associated with a tremendous surge of cytokines, chemokines and soluble mediators which are primarily ..read more

The trend of using digital tools for communication and information sharing in the life science industry has gained traction. Market access professionals work differently today. This shift began over the past decade. Recently, advancements in digital technology have accelerated. This is due to changes in healthcare delivery such as value-based care and patient-focused approaches. Additionally ..read more

Your biotechnology start-up’s candidate asset has an intriguing proof of biology. Your investors are equally excited about it, and everything looks rosy regarding your future investments. You have a draft target product profile (TPP) that is all developed and squared away.   Now, it is time to put your ideas into action! Admittedly, you run into ..read more

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to helping improve medical research through data standardization. CDISC has worked closely with the FDA to introduce data standards, which make it easier for regulatory reviewers to understand and process clinical trial data. Standardized data has been a mandatory FDA requirement for all clinical studies submitted ..read more