What are the advantages of a hospital-based Early Phase Unit?

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....

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Biomapas joins SwedenBIO organization

Biomapas joins SwedenBIO organization

December 2021 Biomapas has joined the SwedenBIO organization starting November 2021. Joining SwedenBIO's mission to promote an environment bringing success and growth to the entire Swedish life science industry, we seek to walk the path in developing the life sciences sector. "Having participated...

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What are the Challenges of Decentralized Clinical Trials?

What are the Challenges of Decentralized Clinical Trials?

The COVID-19 pandemic has accelerated the adoption of decentralized clinical trials by emphasizing the tangible advantages of virtual trials and their ability to improve the patient and physician experience. Moreover, it requires stakeholders to devote time and resources before reaping the...

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Download – ABO Whitepaper

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...

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Challenges In Early Phase Oncology Trials

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 in 2020. By 2040, the worldwide cancer burden is predicted to reach 28.4 million cases. Female breast cancer is the most often diagnosed type of cancer, followed by lung, colorectal,...

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What is the Clinical Trials Regulation?

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...

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Different Affiliate Based Outsourcing Models for Regulatory Affairs

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...

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Marketing Authorization Process in Russia

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...

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Drug Registration in Russia

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...

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What is Medical information and Communication?

What is Medical information and Communication?

It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies have transformed how we share information and interact with Healthcare Professionals and Patients. The advances in automation, digitization, real-world evidence & Big Data analysis...

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Preparing for the Affiliate-Based Outsourcing for Regulatory Affairs

Preparing for the Affiliate-Based Outsourcing for Regulatory Affairs

Affiliate-Based Outsourcing (ABO) model for regulatory affairs works as a replacement or an extension of the company's internal local regulatory resources, which often do not fully fulfil the needs for the effective organization, flexible resources, business continuity, cost optimalization and...

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Drug Registration in the Eurasian Economic Union (EAEU)

Drug Registration in the Eurasian Economic Union (EAEU)

If you are interested in marketing your medicinal product in the fast-growing pharmaceutical market of the Eurasian Economic Union (EAEU) and if you want to how to apply for market authorization in the EAEU, this blog post is for you. The first part of this article describes why the EAEU is an...

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