Let's get started with data management for clinical investigations!
Clinical investigations, especially decentralized investigations, are built on electronic collection and handling of data. At the same time, a medical device developer has to work in compliance with the regulations such as GDPR and MDR.
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The purpose of the guide Data Management in Clinical Investigations is to help medical device manufacturers to understand the scope of data management activities and plan for success.
We will dive into the following:
- What does data management in clinical investigations mean?
- Automating data validation checks in clinical investigations
- Challenges and pain points in data management in clinical investigations
- Introduction to General data protection regulation (GDPR) in clinical research
- Data security and Electronic Case Report Form (eCRF) / Electronic Data Collection system (EDC)
- Administrative requirements and technical requirements in data management
- Opportunities: What is the role of data management in clinical research?
- There are a lot of details to manage and questions to consider, and what is more, a lot to achieve.