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Clinical Research Solutions
Earlier this year, the Officer of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance...
Clinical Research Solutions
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Clinical Research Solutions
As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...
Clinical Research Solutions
Over the past several years, pharmaceutical company Corporate Integrity Agreements (CIAs) have routinely required needs assessments in connection with the engagement of healthcare professionals...
Clinical Research Solutions
It is amazing to me that more C-Level Executives do not perceive their Quality Systems as a powerful vehicle to reduce costs, improve productivity, and benefit their bottom line. Rather than embrace...
Clinical Research Solutions
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...
Clinical Research Solutions
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...
Clinical Research Solutions
Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...
Clinical Research Solutions
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
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
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...
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...
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...