Running A Clinical Trial In Georgia
Moving Clinical Trials away from Ukraine and Russia Russia, Ukraine, and other CIS countries have been significant contributors to clinical trials in many therapeutic areas for several years. With access to experienced investigators, good quality, and large patient populations, we could often...
Running A Clinical Trial In Kazakstan
Moving Clinical Trials away from Ukraine and Russia For a long time, Russia, Ukraine and other countries in the Commonwealth of Independent States (CIS) have been the host of ample clinical trials in various therapeutic areas. And for a good reason: countries in the region provide access to large...
Artificial Intelligence in Pharmacovigilance
Automation & AI in Pharmacovigilance: Promises and Realistic Expectations Recent years have seen increasing pharmaceutical companies' pharmacovigilance (PV)-related activities. The promise of artificial intelligence (AI) and automation is often mentioned as a way to meet the increasing PV...
How to Avoid Delays in Your Early Phase Oncology Trial?
Webinar: How to Avoid Delays in Your Early Phase Oncology Trial? Many things can go array in your early phase oncology trials, from protocol development, taking care of a safety profile, getting the ethics committee / regulatory authority’s approval, managing vendors, and much more. They all cost...
Pharmacovigilance Opportunities in the MENA Region
Webinar: Pharmacovigilance Opportunities in the MENA Region Pharmacovigilance is getting more and more attention in MENA countries thanks to new regulations and steps in the right direction. The MENA region itself holds great promise for the pharmaceutical industry, being potentially hugely...
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 comparing the MENA region and Europe and inter-country differences in the MENA region. Local legislation and requirements will be discussed, such as requirements on periodic safety...
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...
Selecting a Pharmacovigilance Drug Safety Database
Selecting a Pharmacovigilance Drug Safety Database The WHO defines pharmacovigilance (PV) as the science and activities related to detecting, assessing, understanding, and preventing adverse effects of a medicinal product or any other possible drug-related problems. A drug safety database is a...
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,...
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 New Drugs (INDs) for all disease categories, with less than 7% of phase I-tested oncology drugs achieving market approval. Moreover, the clinical development time for medicinal oncology...
Biomapas Announces Two New Appointments to Board of Directors
February 2022 Biomapas, a full spectrum clinical, regulatory, pharmacovigilance and medical information solution provider, is pleased to announce the two new members joining its board of directors. Coming from life science, biopharmaceutical and financial industries, they bring years of experience...
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 significantly obstruct the development of innovative treatments. There is an undeniable increase in demand for Early Phase Clinical studies in patients to enable informed decision-making....
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 cautious about running more extensive early-phase patient trials in a single Phase I unit due predominantly to the doubt over actually being able to recruit large patient populations....
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...
