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Clinical Research Solutions
When it comes to usability studies, the focus should be on effectively preparing the medical device for use in humans. Whether a Sponsor is conducting formative testing or validation testing, the...
Clinical Research Solutions
Every industry has a distinct set of obstacles to overcome, but it’s no secret that the life sciences industry encounters more speedbumps than most. Market cycles and product failures are expected,...
Clinical Research Solutions
In January 2020, FDA issued a final guidance document on the topic of “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture...
Clinical Research Solutions
As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal...
Clinical Research Solutions
Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to...
Clinical Research Solutions
Before using a significant risk medical device in a clinical study, Sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and...
Clinical Research Solutions
In late 2018, FDA announced changes to modernize and increase the efficiency of its 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the...
Clinical Research Solutions
The threat of cyber-attacks against medical devices is real. Medical devices capable of connecting, wirelessly, wired, or to portable media such as a USB drive, are more vulnerable to cybersecurity...
Clinical Research Solutions
On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress. Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act...
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...
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...
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...
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
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...