Synterex Blog

The European Union’s Artificial Intelligence Act (EU AI Act) has become a significant milestone in the global regulation of artificial intelligence. As the world’s first comprehensive AI regulation, it introduces a risk-based framework designed to ensure the safe and ethical deployment of AI technologies. For industries relying heavily on innovation, like biopharma clinical trials, understanding this regulation is crucial.

In clinical trials and healthcare, data comprise the foundation of every decision, from designing study protocols to analyzing patient outcomes. As artificial intelligence (AI) increasingly shapes clinical operations, data governance has become a critical factor in ensuring data quality, compliance, and ethical AI deployment. Data governance involves the management of data availability, usability, integrity, and

Digital transformation in the biopharma industry isn't just about adopting the latest technologies—it's about fundamentally reimagining how clinical trials are designed, conducted, and analyzed. This shift involves integrating artificial intelligence (AI), cloud computing, and data analytics to streamline operations, accelerate drug development, and improve patient experiences.

AgileWriter™ is an AI tool designed specifically for medical writing, developed by experts in the field to meet the precise needs of clinical documentation. Importance of Subject Matter Experts: Involving subject matter experts (SMEs) in the creation of AI tools for medical writing ensures the tool is practical and meets user needs, avoiding misalignment and inefficiencies.

In today’s fast-evolving digital landscape, digital employee experience (DEx) is more than just a buzzword—it’s an essential aspect of organizational success, particularly for professionals like medical writers.

In the realm of pharmaceutical innovation, the Investigational New Drug (IND) application is a pivotal gateway, marking the initiation of clinical trials and the potential journey toward a groundbreaking new medication.

<p>Deadlines to meet, projects to juggle, and dynamic demands? Work can be stressful at times. It’s no wonder people feel anxious and overwhelmed. Well, that’s when you might want to spend some time on a yoga mat! Physical and mental health are strongly related, and their relationship is well described in literature, too. Frequent stress&hellip;</p>

Establishing early alignment with the FDA on the rolling submission approach is pivotal to your success. Before you initiate any submission activities, ensure you have secured the FDA's agreement on both the timing and the scope of your rolling submission.

Managing information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product's approval process. To succeed, it's important to follow best practices that focus on clarity, accuracy, and efficient project management.

What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products.

<p>When pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to approval is often fraught with potential delays. Understanding these risks—and knowing how to mitigate them—can make or break your timeline. Top 10 most common risks and expert tips on how to manage them effectively 1.&hellip;</p>

As artificial intelligence (AI) permeates various aspects of life and business, the importance of explainable AI (XAI) grows, particularly in content creation tools—especially when those are being used in a regulated environment. Explainable AI enhances user trust by making the workings of AI systems transparent and comprehensible.

The World Health Organization (WHO) has long been a guiding force in global health issues, setting standards and offering recommendations to ensure the well-being and safety of populations worldwide.

In an era dominated by rapid advancements in artificial intelligence (AI), the need for robust governance frameworks has never been more critical. The Universal Guidelines on Artificial Intelligence (UGAI) represented a pioneering effort to address the ethical, legal, and societal challenges posed by AI technologies.

Artificial intelligence (AI) continues to reshape industries, societies, and economies globally. As AI technologies evolve and integrate deeper into various sectors, establishing robust frameworks to manage their development and use becomes crucial. The Organization for Economic Co-operation and Development (OECD) has taken significant steps in this direction with its Recommendation on Artificial Intelligence.

The United Nations General Assembly in March 2024 adopted a significant resolution aimed at leveraging artificial intelligence (AI) for sustainable development while ensuring it remains safe, secure, and trustworthy. This initiative underscores a global commitment to balancing technological advancement with ethical standards, human rights, and social inclusiveness.

The National Institute of Standards and Technology (NIST) has developed a comprehensive framework aimed at enhancing the trustworthiness of AI systems. This framework, known as the NIST AI Risk Management Framework (AI RMF), is designed to support stakeholders across industry, academia, and government in fostering responsible AI development and deployment.

In today’s digital age, accessibility in technology is not just a feature—it's a necessity. As a disabled-owned company, we recognize the importance of creating tools that everyone can use, particularly when it comes to AI-enabled and intelligent authoring systems.

Many side effects can result from poor posture: shoulder, neck and back pain, circulation issues, dizziness and even depression, to name a few. 

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision of its E6 Guideline, also known as ICH E6 (R3). This revision introduces new concepts and updates in the realm of clinical trial methodologies, with an emphasis on quality, flexibility, and modernization.