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 […]
GENINVO is delighted to exhibit at Informa Connect 2023! You can visit us at Booth #4.
GENINVO is aware and up to date with evolving data privacy rules across the globe and, In Informa connect 2023 we are looking forward to present on: “SMEs and machines working together to fuel the automation of anonymization.” Evolution of anonymization process from manual to automation. SME’s role in building the automated anonymization tool. ROI […]
GENINVO is delighted to exhibit and present again at the PHUSE US Connect 2023! You can visit us at Booth #7.
PHUSE US Connect 2023, Let’s have insightful conversations to help understand your gap areas and further develop our products to perfectly fit into your organization. Our team is producing transformational software solutions using years of experience in life sciences industry, collaboration with industry forums, leading edge technologies and our software development capabilities, data-engineering practices, cloud expertise, […]
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 […]
Shadow for EU-CTR Compliance
