ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
A Project Management Office ("PMO") can be incredibly advantageous to large companies with many ongoing projects across various job sites. A PMO streamlines project management processes to make a...
Clinical Research Solutions
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
It's no secret. To be successful in the life sciences industry you must accomplish a lot – achieve and maintain profitable growth, deliver safe and effective products to patients quickly, manage...
Clinical Research Solutions
The Medical Device Single Audit Program (MDSAP), initiated by the International Medical Device Regulators Forum (IMDRF), created a global approach to auditing and monitoring the manufacturing of...
Clinical Research Solutions
Over recent years relations with data and its weight have changed significantly; consequently, an assessment of Company Data Integrity is becoming one of the key metrics of corporate functionality...
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
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...
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
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...