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Contact
Legal and Regulatory
eTMF Essentials : What Really Matters
Don’t make these mistakes. Top features you need to look out for when implementing your eTMF system
Tom
(4 min)
Legal and Regulatory
21 CFR : Making Sense of it All
We talk a lot about 21 CFR (especially part 11) in clinical research - there's so much more to it than meets the eye
Tom
(5 min)
Legal and Regulatory
Integrated Research Application System (IRAS) : An Introduction
If you're conducting human participant research in the UK, you will need to be aware of IRAS
Tom
(4 min)
Legal and Regulatory
Audit Time! What you Need to Cover
Demonstrating compliance in your clinical trials conduct should be straightforward - here's how to compile the most important information for audit review
Tom
(5 min)
Legal and Regulatory
Making Sense of GDPR in Human Trials
The term "GDPR" can incite fear and worry in the minds of many researchers. Here's what GDPR means for your human participant research
Tom
(5 min)
Legal and Regulatory
Borders, International Ethics and Standards
You need to conduct research across many borders in diverse populations and adhere to international ethical standards and practices. Here's how...
Tom
(3 min)
Legal and Regulatory
SOPs in Human Trials : Guidelines and Best Practices
Standard Operating Procedures (SOPs) ensure proper trial conduct to regulatory guidelines and frameworks - how should you work yours according to best practices?
Tom
(5 min)
Legal and Regulatory
Is My Work Considered Research?
Addressing one of the most fundamental questions in data collection. Is my work even 'research'?
Tom
(3 min)
Legal and Regulatory
Do I Need Ethical Approval for my Study?
Strong ethical guidelines protect participants in trials - but when do they come into play?
Tom
(3 min)
Legal and Regulatory
Trials Documents : The Essentials
Keeping documentation up to date, fully transparent and up to regulatory standards can be tricky. Here are some of the most essential trials documents you should be aware of
Tom
(5 min)
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