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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.

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AI in GxP: Recurring Compliance Gaps

What challenges are we seeing as life sciences organizations expand AI adoption?

Artificial intelligence (AI) is increasingly embedded in compliance areas like medical information, pharmacovigilance, clinical operations, manufacturing, quality systems, and other regulated processes.

Patient and Healthcare Provider Surveys

Full-Service CRO

Patient and Healthcare Provider Satisfaction Surveys: Maximizing Response Rates

Customer perception and satisfaction play a pivotal role in shaping the success and reputation of pharma companies. Given the significance of these factors, it's understandable that many pharma...

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Full-Service CRO

7 Reasons Projects Fail (And How to Ensure Success)

Leadership at drug and devices companies are continually overwhelmed with the constant balance of driving daily work, managing resources, and addressing unplanned emergencies. This balance is then...

Digital Transformation

Best Practices for Veeva Vault Software Upgrades & Release Management

Across biotech startups and global pharmaceutical companies alike, Veeva Vault continues to expand market share. With 1,300+ customers, Veeva Systems is one of the largest providers of cloud...

Meet the Expert: Long Tan (Tom)

Meet the Expert: Long Tan [Tom]

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...

Meet the Expert: Amol Yelgaonkar

Meet the Expert: Amol Yelgaonkar

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...

CRISPR drug development project management pathogenic DNA

Full-Service CRO

Key Challenges of CRISPR Drug Development Project Management

CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, is a gene-editing technology that holds enormous promise for treating genetic diseases. However, developing CRISPR-based drugs is...

Meet the Expert: Ana Ming

Meet the Expert: Ana Ming

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...

Specialty drug development project management scheduling concepts with ProPharma's flywheel overlaid

Full-Service CRO

Key Challenges of Specialty Pharma Drug Development Project Management

Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

Meet the Expert: Collin Freeman

Meet the Expert: Collin Freeman

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...

Meet the Expert: Tiffany Rice

Meet the Expert: Tiffany Rice

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...

Quality & Compliance

Meet the Expert: Alexis O'temro

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...

Meet the Expert: Dr. David Crome

Meet the Expert: Dr. David Crome

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...

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7 Considerations When Implementing and Maintaining a Research Data Management Platform

Investments in digital transformations are expected to grow from $594.5 billion USD in 2022 to $1.548.9 billion USD by 2027, with the goal of improving the generation, collation, storage, and...

Meet the Expert: Amy Scalise

Full-Service CRO

Meet the Expert: Amy Scalise

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...

Sophisticated pharmaceutical manufacturing machines in progress.

Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023

The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...

What to Expect During the NDA Review Process

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...

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Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

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...

FDA Shelf Life Extension Program (SLEP)

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...

An Overview of the PSMF: Pharmacovigilance System Master File

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...

Illustration of the Common Technical Document (CTD) Triangle

The Importance of the eCTD Structure for FDA Approval

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...

child-receiving-medical-care-rare-disease

The End of the FDA's Rare Pediatric Disease Priority Review Voucher Program

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....