Technology plays an important role in transforming traditional clinical research into more digitalized and modern. The introduction of electronic data capture systems (EDC System), randomization and trial management supply, ePROs, eCRFs, and more has completely changed how clinical trials are conducted across the globe.
However, it does bring a different set of challenges to CROs, sponsors, and others involved in clinical research. They have to take proactive measures to ensure data security and abide by the various ethical standards of regulatory bodies such as the FDA.
Cyberattack is a major headache faced by organizations involved in clinical research. Confidential documents relating to COVID-19 studies have been leaked in the past, and there is a greater emphasis on protecting sensitive patient data. Having said that, you shouldn’t be discouraged from using technology in your trials. Here are some signs that indicate that your EDC takes data security seriously.
One of the ways to identify whether your EDC takes data security seriously is to look at its infrastructure design. The system should ensure that no data leaves the internal system before being encrypted via SSL and RSA keys. When conducting on-site trials, you need to ensure that the area is closely observed by authorized personnel. Data should have limited access and should only be accessed by relevant authorities.
A good data backup and disaster recovery plan also indicate that you take data security seriously. There should be adequate backups of data, ideally in another location. You need a multi-layered security approach to secure your EDC system and protect your physical and digital assets.
Secure Data Transfer
As mentioned, restricted access and multi-layered security infrastructure are key to maintaining a secure EDC system. Data transfers should be secure and appropriately documented. Leaks can happen internally, so make sure to only authorize relevant personnel to access data. Transfer logs ensure accountability and traceability in an unfortunate event where transfers are compromised
Monitoring and Vigilance
As you know, data integrity is crucial to conducting safe, secure, and effective trials. If your EDC system is monitored regularly and data transfers have a proper audit trail, then you are certainly taking your data security very seriously. You can implement quality EDC systems provided by ClinicalPURSUIT that adopt a no-compromise approach to data security. A 24/7 monitoring system to ensure your crucial data’s safety.
Get Started with ClinicalPURSUIT
Ensuring data security within your clinical trial can be difficult without the help of an expert EDC software provider such as ClinicalPURSUIT. Our Clinical Trial Data Management Solutions and Clinical Trial Data Management Software are the best in the business and are HIPPA compliant. We also provide products and services such as Randomization and Drug Supply Management, Electronic Patient-Reported Outcome Software, Clinical Electronic Data Capture Software, and more.
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