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Clinical Research Solutions
Is remote Computerized Systems Validation the future standard? Crises are fertile ground for inspiration and creativity resulting in practical new ideas for the near future, as is the case during the...
Clinical Research Solutions
Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...
Clinical Research Solutions
Everything You Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from...
Clinical Research Solutions
In order to optimize the storage and reuse of data within your organization, we recommend that you consider implementing data standards throughout your business. In our previous blog post "An...
Clinical Research Solutions
Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in...
Clinical Research Solutions
EMA has extended the deadline to assess the risk of nitrosamine impurities to 31 March 2021. This decision was made based on the reports of the challenges encountered in meeting the original deadline...
Clinical Research Solutions
Due to the current regulatory landscape that has been created by the COVID-19 pandemic, clinical trials have been disrupted across the globe. To many Sponsors, this may feel like a loss of progress...
Clinical Research Solutions
The landscape of clinical trials and other clinical development projects has dramatically changed in recent years. Progress made in scientific discovery is paving the way to novel therapies and...
Clinical Research Solutions
On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential...
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...