April 18, 2023
4 min read
When to Start Thinking About Risk Management and How to Prepare for a REMS
Learn about the importance of preparation and contingency planning for risk management and REMS.
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Blog
October 30, 2025
6 min read
Drug Repurposing in Rare Diseases: The Impact of Natural History Studies
Drug repurposing is transforming the landscape of rare disease treatment by leveraging existing medications for new uses. With significantly lower development costs and faster timelines, this approach is gaining traction—especially when supported by natural history studies that provide deep insights into disease progression and real-world treatment patterns.
Blog
October 23, 2025
6 min read
EMA Issues Guidance on Risk Minimisation Measures for Medicinal Products with Embryo-Foetal Risks
The EMA’s August 2025 guidance on embryo-foetal risk minimisation marks a pivotal step in harmonizing safety protocols across the EU. This blog breaks down the new Addendum I to GVP Module XVI, clarifying what constitutes a Pregnancy Prevention Programme and how risk minimisation tools can be effectively implemented without compromising patient access to essential treatments.
Blog
October 20, 2025
9 min read
To Rescue or Not to Rescue Your Study: How to Spot Trigger Points in Strategic Partnerships
Instability is woven into our industry’s DNA. We operate daily in a high-stakes, high-risk environment where financial pressures, regulatory changes, and patient lives hang in the balance. The CRO selection process reflects this tension, few other sectors require competitors to both challenge and collaborate with one another, often for the same client. Our ecosystem is […]
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Blog
Articles
April 14, 2023
2 min read
Evaluating Existing Safety Surveillance Regulations for Drug Development
UBC's pharmacovigilance experts compare current safety regulations in Advances in Therapy.
Articles
April 11, 2023
25 min read
External Controls in Research: The “What, Why and How”
Experts across various domains come together to discuss and highlight various key aspects of using external control arms.
Blog
March 30, 2023
6 min read
Maximize Gross-to-Net While Optimizing Your Patient Service Strategy
Patient service programs can often overextend themselves relative to a brand's revenue. Read how to avoid this in three key areas.
Blog
March 21, 2023
4 min read
Driving Patient Services that Place the Patient at the Center
Are you taking the time to put patients at the center of your support services? And what does that look like?
Blog
March 14, 2023
8 min read
Moving Safety Activities Forward – Fierce Pharma Drug Safety Summit 2023
Learn about the key themes in REMS and pharmacovigilance that were discussed at this industry conference.
Blog
March 2, 2023
5 min read
Regulatory Update: Selective Safety Data Collection in Clinical Research
Read how the latest guidance from the FDA could change what safety data you need to collect.
Blog
February 27, 2023
5 min read
Make Your Copay Program a Brand Rock Star with Actionable Insights
See how data drives optimized affordability program design & execution to maximize the effect for your brand.
Blog
February 23, 2023
4 min read
SCOPE 2023 – Bringing Focus onto the Patient
This year's SCOPE Summit focused on the hybridization of research facilitating better evidence generation through patient-centric study design & execution.
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