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Clinical Research Solutions
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
Clinical Research Solutions
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...
Clinical Research Solutions
In the first blog of this three-part series, “Overlooking Your QMS Could Cost You,” we discussed the cost of “good” versus “poor” quality, and the importance of investing in a “good” Quality...
Clinical Research Solutions
Drug and medical device development and manufacturing is a complex process that involves multiple supply chains, various monitoring systems, and countless players from R&D to market. Due to the...
Clinical Research Solutions
Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...
Clinical Research Solutions
A Quality Management System (QMS) bridges an organization’s individual compliance practices with regulatory requirements. It establishes the infrastructure and oversight requirements for...
Quality & Compliance
The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...
Clinical Research Solutions
Improve your R&D Strategy with These 6 Tips. In 2017, R&D investments in the pharmaceutical space reached more than $70 billion, with projected figures of over $200 billion by 2024. Pharma is one of...
Clinical Research Solutions
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
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...