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.
Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights
As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a robust and compliant MI function is crucial to the success of the product lifecycle and demonstrates...
Roadmap for Successful IVDR Transition: The compliance dates for the In Vitro Diagnostics Regulation (IVDR) will become effective on May 26, 2022. To help you with the IVDD to IVDR transition, we've...
With an increased need for high quality in vitro diagnostic medical devices (IVDs), the In Vitro Diagnostic Regulation (IVDR, 2017/746) was entered into force for all IVDs in 2017 with a five-year...
Should You Undergo Virtual Factory Acceptance Testing?
Although domestic travel is slowly ramping up, companies may still consider virtual factory acceptance testing (FAT). FAT is an optional step in the life sciences’ process of purchasing factory...
Regulatory Strategy for Clinical Trials in the European Union
Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...
Is it Time to Sharpen Your Target Product Profile (TPP)?
Is it Time to Sharpen Your Target Product Profile (TPP)? We’ve heard it countless times: “Fail early and live to fight another day.” “Preserve capital, human resources, and energy for a project with...
Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
Decentralized Clinical Trials: Changing the Landscape of Clinical Trials
One essential consideration in clinical trial development is whether the trial will represent a given population. The most representative trials use recruitment techniques and advanced statistical...
A Roadmap for Clinical Trials: QP Certification of IMP
Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....
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...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
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...
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...
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...
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...
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
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...