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Data Integrity in Clinical Research: Audit Trail Review as a Key Tool A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit...
Regulatory Sciences
No one has an ugly baby. At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. But the unfortunate fact is that there are ugly babies....
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...
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
Quality & Compliance
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
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
If you are involved in early development of biopharmaceuticals, have you ever experienced serious delays because of problems arising from tech transfer, from the first pilot scale batches not meeting...
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...
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...
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
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...
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....
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...
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...
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...
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...