Insights & Resources
For Life Sciences Professionals.
Whether you’re a healthcare professional, a researcher, or simply interested in 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!
Featured Insights
The Perfect Match: How Mid-Sized CRO–Site Network Partnerships Drive Clinical Trial Success – Watch the Recording
How medical writing supports every stage of the drug’s lifecycle
Discover how clinical research and medical writing intertwine across all phases of drug development, from drafting early trial documents to post-marketing activities.
Harmonizing Product Information Across Baltic Markets
In this case study, we share how one of our partner companies successfully harmonized their SmPC, PIL, and labelling across the Baltic region, working with our medical writing experts.
Topic
Pharmacovigilance Opportunities in the MENA Region
Pharmacovigilance is getting more and more attention in MENA countries thanks to new regulations and steps in the ...
Pharmacovigilance in the MENA Region
This blog focuses on pharmacovigilance (PV) in the MENA Region; the Middle East and North Africa. We do this by ...
Selecting a Pharmacovigilance Drug Safety Database
Selecting a Pharmacovigilance Drug Safety Database
The WHO defines pharmacovigilance (PV) as the science and ...
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 ...
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 ...
How To Manage An Early Phase Oncology Study: Project Manager Insights
Clinical development of oncology drugs has one of the lowest success rates of the development of Investigational ...
How To Improve Patient Recruitment In Early Phase Oncology Trials
The difficulties of recruiting in clinical trials, and particularly cancer patients in their early stages, can ...
What are the advantages of a hospital-based Early Phase Unit?
Choosing the right setting for your early phase trial can be challenging. As a sponsor, it's natural to remain ...
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 ...
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 ...
What are the Challenges of Decentralized Clinical Trials?
The COVID-19 pandemic has accelerated the adoption of decentralized clinical trials by emphasizing the tangible ...
Affiliate Based Outsourcing
Whitepaper
Regulatory Affairs Outsourcing
Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition ...
Challenges In Early Phase Oncology Trials
Cancer is the biggest cause of mortality globally, with 19.3 million new cases and over 10 million deaths expected ...
What is the Clinical Trials Regulation?
The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By ...
Different Affiliate Based Outsourcing Models for Regulatory Affairs
Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs
Often questions arise about the ...
What is Medical information and Communication?
It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies ...
Preparing for Affiliate-Based Outsourcing for Regulatory Affairs
Affiliate-Based Outsourcing (ABO) model for regulatory affairs works as a replacement or an extension of the ...
Drug Registration in the Eurasian Economic Union (EAEU)
Drug registration in the EAEU: Learn about pathways for market authorization, the CTD format, and approvals in the Eurasian Economic Union.
Marketing Authorization Renewal in the MENA Region
Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization ...
How to register a Medical Device in the EAEU
Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: ...
