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Clinical Research Solutions
Regulatory Strategy for Clinical Trials in the European Union: Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27...
Clinical Research Solutions
Is it Time to Sharpen Your Target Product Profile (TPP)? We’ve heard it countless times: “Fail early and live to fight another day.” “Preserve capital, human resources, and energy for a project with...
Clinical Research Solutions
Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...
Clinical Research Solutions
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
Clinical Research Solutions
One essential consideration in clinical trial development is whether the trial will represent a given population. The most representative trials use recruitment techniques and advanced statistical...
Clinical Research Solutions
Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....
Clinical Research Solutions
If you work in a regulated industry, you’ve most likely heard the term eQMS or enterprise quality management system. But you may be wondering what is it? Why do I need it? And how do I choose the...
Clinical Research Solutions
On Friday, October 29, 2021, the EMA published a statement providing marketing authorization holders (MAHs) recommended submission dates for 2021 variations in order to meet the regulatory deadlines....
Clinical Research Solutions
A recent survey showed that 33% of the organizations surveyed use paper quality management systems; 60% use some paper and some digital; and 7% use no QMS yet. (source: Gartner peer insights) Quality...
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...