Insights & Resources For Life Sciences Professionals.
Whether you’re a healthcare professional, a researcher, or simply interested in the drug development, you’ll find valuable information and resources here that can help you stay informed and make informed decisions. Let us know what else you’d like to hear about!
Clinical Trial Diversity
Why is diversity in clinical trials so important, and what challenges does the industry face in achieving it? Explore ethical considerations, practical hurdles, and recent guidelines from the FDA and EMA in our latest article by Jan Filakovsky, CEO of Biomapas.
Literature monitoring of Pharmacovigilance in realities of war in Ukraine
It is fascinating to observe how the realities of war have affected the way in which the literature monitoring of Pharmacovigilance is carried out in Ukraine. The need for continuous monitoring of drug safety in a country at war, and the ability to adapt to the circumstances for ensuring the...
Pharmacovigilance & CSV: System Upgrades
Explore the intersection of Pharmacovigilance & CSV during system upgrades. Ensure drug safety while optimizing computer system validation.
CSV & Risk Management in Pharmacovigilance
CSV & Risk Management Pharmacovigilance stands as a guardian in drug development and monitoring, ensuring that medicines remain safe and effective throughout their lifecycle. But behind this sentinel lies a complex web of systems, processes, and regulations, each meticulously designed to...
Discover how ICSR Pharmacovigilance safeguards drug safety for patients.
How individual case study reporting tracks adverse drug reactions and helps ensuring medication safety.
Expert Guidance on PSURs: Ensuring Drug Safety
Why are PSURs important? How do you write a PSUR? Find out all how PSURs and their role in guaranteeing patient safety.
Literature Monitoring in Pharmacovigilance
Incorporating data from medical and scientific literature is a paramount aspect of patient safety. This wealth of knowledge often constitutes a substantial part of the safety profile of medicinal products. From providing insights on potential side effects to shedding light on different patient...
All you need to know about the FDA’s Draft Guidance on Diversity Action Plans
The U.S. Food and Drug Administration’s (FDA) draft guidance on Diversity Action Plans (DAPs) is a significant step towards addressing the underrepresentation of diverse populations in clinical research. Released in June 2024, this guidance aligns with broader efforts to ensure clinical trials...
Unlocking Success: The FSP Advantage in Clinical Research
The Functional Service Provider (FSP) models in clinical research are becoming increasingly appealing to the pharmaceutical and biotechnology sectors, offering flexible and scalable solutions to outsource specific functions . Currently pharmaceutical and biotech...
Bridging Gaps in Clinical Trials: Enhanced Access & Embracing Diversity
Explore the crucial role of diversity and accessibility in clinical research in this insightful article.
Adaptive Clinical Trials
What are Adaptive Clinical Trials? And how can we leverage their distinguished ability to evolve to improve clinical designs?
Clinical Endpoints In Early Phase Oncology Trials
Clinical Endpoints In Early Phase Oncology Trials: Discover their influence on safety, study design, and regulatory compliance.
Choosing A Global Or Local CRO: A Comparative Analysis
Choosing a global or local cro? Learn what to consider when selecting a partner for global trials that require specialized, local expertise.
Let’s celebrate success
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new countries all around the globe and the...
How can a CRO support Mergers & Acquisition
The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years due to the growing number of...
The Role of Regulatory Intelligence in Pharmacovigilance
Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It's so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly. What Is Regulatory Intelligence? Regulatory Intelligence is...
Q&A. How does the conflict between UA & RU impact the pharma industry?
Webinar: How does the conflict between UA & RU impact the pharma industry? Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And with good reason. Russia's invasion of Ukraine affects millions of people, not...
How does the Russian invasion impact the pharmaceutical industry?
Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And, with good reason. Russia's invasion of Ukraine affects millions of people, not just in this Eastern European nation but throughout the world. As a result,...
Smooth Switch to the EAEU Marketing Authorization for Medicinal Products
Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you towards a successful...
