Rethinking Biometrics Resourcing in Modern Clinical Trials
Rethinking biometrics as a strategic function to improve consistency, scalability, and clinical trial performance.
Quality & Compliance
Top Tips for a Successful Virtual Audit
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...
An Introduction to Scientific Data Standards
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...
Regulatory Sciences
COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials
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
5 Scenarios That Need a Clinical Operations Team
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
Ten Tips for Conducting Successful Virtual FDA Meetings in the Era of COVID-19
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...
Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part II
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...
Regulatory Sciences
Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part I
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...
Quality & Compliance
Do You Need a Project Management Office (PMO)?
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...
Quality & Compliance
Embracing Risk Management Principles: As Easy as One, Two, Three
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...
Meet the Expert: Ewelina Czerniec-Michalik
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 support...
Clinical Research Solutions
7 Medical Writing Tips for the Oncology Field
In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of...
Clinical Research Solutions
Changes in Medical Device Regulatory Requirements in Europe (2021)
In May 2021, the new European regulations on medical devices (EU MDR) will take full effect. Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions...
Quality & Compliance
FDA: CGMP Consultant Recommendation
Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...
Meet the Expert: Dr. Borja López Pérez
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 support...
Clinical Research Solutions
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...
