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!
Pharmacovigilance in Early Phase Clinical Trials
Welcome to the fascinating yet complex world of Pharmacovigilance (PV)! This field stands as an indispensable pillar in drug safety, ensuring the well-being of millions around the globe. However, the path is far from smooth; it's full of unique challenges and critical responsibilities, especially...
Outsourcing in Pharmacovigilance
Imagine a pharmaceutical company navigating the intricate labyrinth of drug development and patient safety. Amid these complexities, an intriguing solution has been emerging: pharmacovigilance outsourcing. This practice involves entrusting a part or the entirety of pharmacovigilance functions to...
Pharmacovigilance & Medical Information: An Integrated Approach
Learn how you can achieve an integration of Pharmacovigilance and Medical Information from our real-world experience.
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...
Setting Up Medical Information In Europe
Setting up a Medical Information Scientific Service The world of healthcare is constantly evolving, and one of the most exciting developments is the rise of medical information as a potential source of differentiation. Technological advances such as Global Medical Information databases and content...
Safety Monitoring in Early Phase Oncology Trials: Key Points to Consider
For all clinical trials, it is crucial that the potential benefits of a medicinal product are determined, while monitoring any potential side effects. However, for early-phase oncology trials, the extensive monitoring of adverse events (AEs) is essential, considering the toxicological...
Pharmacovigilance in Early Phase Clinical Trials
Welcome to the fascinating yet complex world of Pharmacovigilance (PV)! This field stands as an indispensable pillar in drug safety, ensuring the well-being of millions around the globe. However, the path is far from smooth; it's full of unique challenges and critical responsibilities, especially...
What is Functional Service Provision?
What is Functional Service Provision? And how can you best make use of its benefits in your clinical research programs?
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...
Clinical Trial Design For Early Phase Oncology Studies
Designing effective early-phase oncology trials is a complex and challenging task, requiring careful consideration of various factors, including patient selection, dosing, safety monitoring, and endpoint selection. In addition, developing targeted therapies has brought new challenges and...
Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation
There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent advancements, one of which is the...
Download – ABO Whitepaper
Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization, flexible resources, business...
What is the Clinical Trials Regulation?
The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the EU. By bringing all...
Different Affiliate Based Outsourcing Models for Regulatory Affairs
Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs Often questions arise about the Affiliate-Based Outsourcing (ABO) Models for Regulatory Affairs:1. How can it fit your specific needs?2. How can it adapt to your organization and setup?3. What are its possibilities of...
Marketing Authorization Process in Russia
Cultural and language problems are a frequent stumbling block for multinational corporations seeking to register drugs in Russia. Additionally, the Marketing Authorization process in Russia is highly complex, and the paperwork frequently changes as the regulatory framework evolves. However, the...
Drug Registration in Russia
Overview of drug registration in Russia The Russian pharmaceutical industry is expected to exceed two trillion Russian rubles in 2020, representing a roughly 10% growth over the previous year. Pharmaceutical revenues are expected to reach 2.35 trillion Russian rubles by 2023. It's also worth...
