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Clinical Research Solutions
Managing compliance for computerized lab systems includes the PC controlling your qualified instruments. This is an integral audit point that must be maintained to ensure compliance. Ah, but you’re...
Clinical Research Solutions
Additional information on the guidance document is available in our preceding FDA News article entitled "Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated...
Clinical Research Solutions
On Friday, September 9th, the FDA announced the availability of a draft guidance entitled “E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.” The draft guidance, which...
Clinical Research Solutions
During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...
Clinical Research Solutions
On Friday, September 9th, FDA announced the availability of a revised draft guidance, entitled “Health Document Submission Requirements for Tobacco Products.” The document was initially published in...
Clinical Research Solutions
On December 16, 2013, the FDA released a proposed rule regarding the safety and effectiveness of certain antibacterial soap products. If finalized, this ruling would require manufacturers of...
Clinical Research Solutions
With the spotlight these days on Data Integrity, it may be easy to lose sight of some fundamental Quality Systems. Core Quality Systems include Document Management, Investigation Management, and...
Clinical Research Solutions
On Wednesday, August 30th, the FDA announced the approval of Sandoz’s Erelzi™ (etanercept-szzs). Erelzi is biosimilar to Amgen’s Enbrel® (etanercept) and is indicated for the treatment of multiple...
Clinical Research Solutions
Additional information on FDA’s guidance document is available in our preceding FDA News article, entitled “FDA Extends Enforcement Deadline for Certain Provisions of the UDI Rule, Part One.” On...
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...