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Clinical Research Solutions
A combination product is composed of any combination of a drug and a device; a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. Consider...
Clinical Research Solutions
Since September 26, 2019, all EU Marketing Authorization Holders (MAHs) of medicines for human use are facing what might be regarded as a new requirement: review their drug products on the possible...
Clinical Research Solutions
Medical writers need to meet a few critical criteria before they publish their work. First and foremost, people want to see accuracy and explicit knowledge of the field when they’re seeking out...
Clinical Research Solutions
A recent survey of experts from 145 cell and gene therapy (CAGT) companies revealed the ability to appropriately optimize the manufacturing process as their top concern. Red flags have been raised...
Clinical Research Solutions
How to Manage the Risk of Elemental Impurities with ICH Q3D: The mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to ensure...
Clinical Research Solutions
The Product Quality Complaint program is an essential tool in a company’s quality and compliance toolkit, not only for reducing patient risk and enhancing customer satisfaction, but because it...
Clinical Research Solutions
GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022. The continuing goal of the amendment is to facilitate timely access to high-quality,...
Clinical Research Solutions
Implementing a multidisciplinary approach in cell and gene therapy product development is critical to the product’s eventual success or failure. In our experience, the consequence of not effectively...
Clinical Research Solutions
How much is too little versus too much when developing quality systems and controls for investigational cell and gene therapies? Because these therapies are being administered to patients during all...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...