The Importance of Automation in Clinical Trials
Introduction Clinical trials are the backbone of medical research and innovation. They play a pivotal role in advancing healthcare, developing new treatments, and improving patient outcomes. However, conducting clinical trials is a complex and resource-intensive process, often plagued by challenges such as data inaccuracies, time constraints, and regulatory compliance. This is where automation steps in […]
Quick Look at Software Testing
Introduction Software testing plays a vital part of the software development lifecycle that ensures the quality, reliability, and performance of all products. It involves evaluating a software application or system to identify defects, errors, or gaps that may impact its functionality. In this blog, we will explore the fundamentals of software testing, discuss the importance […]
Ensuring GDPR Compliance with Advanced Data Anonymization Solutions
Introduction In an increasingly interconnected world, where every digital interaction leaves a trace, safeguarding personal data has become a paramount concern. The General Data Protection Regulation (GDPR), a comprehensive legal framework enacted by the European Union, stands as a sentinel of individual privacy rights. In this era of data-driven insights, organizations are not only tasked […]
Managing Product Development Amidst Regulatory Changes Landscape
Introduction In today’s fast-paced business environment, product development is a critical aspect of staying competitive and meeting consumer demands. However, the landscape of product development has been significantly influenced by an ever-changing regulatory environment. Companies across various industries are required to comply with an array of regulations that affect product design, safety, manufacturing, marketing, and […]
Overview of Clinical Data Sharing and Data Anonymization
Need for Data Sharing For biomedical research, Clinical trials are essential components as they lay down the foundation for the researchers to investigate the significance of various treatments and interventions given to humans for disease cures. The urgency for Clinical Trial Transparency is highlighted by the Declaration of Helsinki and the World Health Organization. It […]
Synthetic Patient Data in Clinical Trials: Why it’s important to have meaningful synthetic data.
It is time consuming and difficult to manually generate the test data to support Clinical Programming (CP)/Biostatistics and statistical processes and the differences in the quality and coverage of only limited type of scenario in test data causes the delay in the quality check processes. To overcome these challenges, we should have the capability to […]
EMA policy 0070 Relaunch in September 2023 – What you should need to know!
EMA Policy 0070 is to be relaunched in September 2023. This was announced by the European Medicines Agency during a webinar held on May 16, 2023. All Marketing Authorization Holders who submit packages to EMA should immediately implement document anonymization processes. EMA Policy 0070, which was originally implemented on January 1, 2015, has been around […]
Automation within Medical Writing
What does medical writing function do? Medical writing is a highly specialized field that involves content writing and clinical research on scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, periodicals, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines, or news. […]
Synthetic Data Vs Real Data
There has been an increase in interest in synthetic data over the past few years for various applications such as machine learning and data analytics. Research predicts that synthetic data will surpass real data by 2030. However, some executives and business leaders may not be familiar with the concept due to its differences from real […]
Data Protection
The impact of globalization on privacy of identity is growing. The fact that more and more Data Protection, comprising data security and data privacy, has emerged as a major challenge in cross-border data flows means that data breaches often affect people in multiple countries and may result in financial frauds. Customers are demanding more security […]
