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.
Regulatory Sciences
As we begin to wrap up the year and look ahead to 2021, it is critical to prepare your team for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring...
Full-Service CRO
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...
Quality & Compliance
If this is your first introduction to an Organizational Maturity Model (OMM), you may have a few questions. What is an OMM? What are some common obstacles I might face when implementing an OMM? How...
Regulatory Sciences
On September 26, 2019, the European Medicines Agency (EMA) released an advice to Marketing Authorization Holders (MAH) of human medicines to review their drug products on possible presence of...
Full-Service CRO
Clinical data and its analysis are critical to clinical research. Ensuring the overall quality of clinical data is then paramount to ensuring quality care and appropriate decision-making in the...
Quality & Compliance
Over the past several decades, the traditional approach to drug development and manufacturing has expanded to include the outsourcing of a range of functions from product development and testing, to...
Full-Service CRO
About 15 years ago, I was a project management director responsible for moving monoclonal antibodies (MABs) from Phase III clinical to commercial manufacturing. I had the distinct pleasure of working...
As you move from Phase 3 clinical trials towards your Marketing Authorization Application (MAA), there are a number of critical steps that must be taken regarding how you interpret your clinical...
Full-Service CRO
The Medical Devices industry breathed a sigh of relief for the new European Medical Device Regulation (EU MDR), but the May 2021 deadline is now right around the corner. The transition from the...
Earlier this year I wrote to you about US FDA March 2020 issuance of a new guidance for industry, Investigators, and Institutional Review Boards regarding the conduct of clinical trials during the...
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Regulatory Sciences
It's the FDA, Not the NBA Aside from being a spectacular thing to watch, the slam dunk is the highest percentage shot a basketball player can take. The likelihood of getting the ball in the basket is...
Full-Service CRO
Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage. Examples of...
Regulatory Sciences
Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution. The European Medicines Agency (EMA) has issued draft guidance on how...
Quality & Compliance
The Annual Product Review (APR), also known as the Annual Product Quality Review (APQR), is required for marketed products in an FDA-regulated environment. You may ask, "Why would I want to perform...
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...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....