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
With automation becoming more mainstream in science, vast quantities of data are now generated by many organizations every day. This deluge of data is often managed ineffectively, limiting the...
Clinical Research Solutions
As of March 27, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations...
Clinical Research Solutions
New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...
Regulatory Sciences
The outbreak of COVID-19 (coronavirus) in the United States has significantly impacted our lives in virtually every way. For pharmaceutical and medical device firms, one of these impacts came on...
Clinical Research Solutions
Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will continue to guide you through all these recommendations and...
Clinical Research Solutions
Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will try to guide you through all these recommendations and...
Clinical Research Solutions
There is more to a project management office than managing projects. In fact, the project management office (PMO) acts as both a watchtower and a lighthouse to guide strategic initiatives toward...
Clinical Research Solutions
In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...
Clinical Research Solutions
This year, four members of our team attended the MHRA Good Practice symposium week. Part of this week were the GPvP Symposium and the joint MHRA and FDA GCP Symposium. Part of ProPharma Group’s...
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...