Clinical trials are a critical part of developing new treatments. For a drug, device, or diagnostic tool to be considered safe and effective, it must undergo thorough research on its effect on human health outcomes. How to measure if a new treatment is effective? Clinical outcome assessments (COAs) are often used for primary or secondary…
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According to a Johnson & Johnson Medical Devices Companies survey, clinicians and healthcare systems prioritize patient outcomes. They are focused on improving operational efficiency and clinical performance while creating a deeper connection with patients as consumers. Implementing patient-centric technology is one way to make the patient experience more convenient, comfortable, and connected while producing highly…
Welocalize becomes one of the first to successfully implement the new model which certifies cloud-based quality processes and systems instead of locations. What is the impact on data security, quality processes, and compliance in virtual work environments? How are global organizations approaching quality management in a cloud-based ecosystem? Now possible, the new ISO virtual-site certification…
Environmental, social, and governance (ESG) are the three factors that measure a corporation’s impact and performance on sustainability and social responsibility. They cover everything from sourcing products and managing resources to practicing workplace diversity and protecting shareholder rights. ESG initiatives have a direct financial correlation in terms of cost saving, stock performance, and lower cost…
The scope of clinical research organizations (CROs) goes beyond clinical trial management. On top of medical device and drug development, CROs are also in charge of bringing new products to the global market. This involves localization, marketing, and regulatory approvals. CROs traditionally work with language service providers (LSP) for their localization and global regulatory compliance needs….
Bringing medicinal products to the market is a slow and intricate process. Aside from exhaustive clinical research, planning, and thorough regulatory reviews, life sciences companies need to stay up to date with the latest guidelines governing these procedures. This post highlights the key changes in the Quality Review of Documents (QRD) guidelines used by the…
Pharmaceutical companies, medical device manufacturers, and contract research organizations (CROs) must comply with regulatory requirements, including guidance on electronic signatures for the life sciences industry. However, many companies are still unaware of these regulations and therefore are not compliant with this guidance. ISO, US, and EU Guidelines on Electronic Signatures There are three guidelines to…
Conversational AI was critical in providing healthcare services during the coronavirus pandemic, serving as healthcare front-liners available to patients 24/7. Chatbots and virtual assistants checked symptoms, scheduled appointments, answered frequently asked questions, escalated emergency cases, and sent reminders to patients. Using artificial intelligence (AI) technologies, such as natural language processing (NLP) and machine learning (ML),…
When it comes to medical device content translations, it’s critical to choose a language service provider (LSP) that adheres to strict international standards. The slightest translation error in instructions for use, product label, descriptions, and marketing materials can significantly compromise the product’s safety and performance. It can contribute to adverse events and risk patient/user safety…
Animal healthcare involves taking care of animals by giving them appropriate drugs, vaccines, diagnostic products, and medicated feed to treat medical conditions. Animals play an important role in human lives. They provide food and companionship. Making their lives better also improves our quality of life. This has led to a growing awareness of animal diseases….
