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Clinical Research Solutions
On November 3rd and 4th, I had the opportunity to meet with Pharmaceutical industry experts at the PDA Outsourcing / CMO conference in Washington, DC. It was a fantastic event with representatives...
Clinical Research Solutions
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...
Clinical Research Solutions
For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list....
Clinical Research Solutions
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...
Clinical Research Solutions
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...
Clinical Research Solutions
There are a number of laws, regulations, and guidance documents ruling the pharmaceutical and biotechnology industries. Laws are passed by Congress and must be followed by the FDA. The Agency then...
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
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
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...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Regulatory Sciences
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
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...
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...
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...