This article looks at how Viedoc can help you keep up with these important legal requirements and make sure you’re always prepared for an inspection.
The FDA is the U.S. Food and Drug Association, and the EMA is the European Union equivalent. Both legislate on the safety of drugs, with patient safety and data integrity their two key considerations.
In parallel, compliance with GCP (good clinical practice) is a legal obligation that applies to all clinical trials of investigational medicinal products, and provides public assurance that the rights, safety, and well-being of trial subjects are protected.
Every country has their own national authority, with all the European countries cooperating under the umbrella of the EMA. Aside from geography though, differences between the FDA and EMA are minimal.
Alan Yeomans, Regulatory Affairs Manager at Viedoc clarifies this, “There's a lot of international cooperation between the different authorities because we live in an increasingly global world, and the goal is to get a medication approved for sale to patients anywhere. The main difference in regulations is due to the different legal backgrounds in the US and in Europe, so they have to be worded slightly differently, but the intention is the same.”
eClinical Forum
At Viedoc, we keep track of regulations through our work with the eClinical Forum. They keep an updated list for systems used in clinical trials, pooled from over 60 different international guidelines.
Alan explains, “We’ve defined a test suite based on the eClinical forum requirements that we perform on every release of Viedoc so we can be sure we’re still compliant. And the eClinical Forum releases an updated version at least once a year, so we update our test suite at the same time too.”
Viedoc inspection readiness package (VIRP)
All customers have access to the VIRP, a document that has been put together based on recommendations gathered from the EMA and from inspector input with regard to what they expect you to know about the systems you're using.
The VIRP is updated with each new system release, and it gives all the necessary detailed information about Viedoc—from the requirements it has been built around, through testing and validation.
Dedicated QA team
Alongside the security of the extensive information contained within the VIRP, it’s also a good idea to let Viedoc know when you're being inspected, and they will make sure someone is available to answer any questions.
It might be indirectly, so you can send across an email detailing the questions the inspectors are keen for us to answer, or they might prefer us to join a meeting so they can hear us answer directly. Either way, as Alan says, “What we do is we make ourselves available. In our experience, not all of the inspections get into details about Viedoc, but we'll support you in any way necessary.”
Audit us
Something that's required in international standards is that sponsors or CROs must have oversight of their important suppliers. The EDC system is usually a major component of any trial, so Viedoc tends to be considered a key supplier.
It’s therefore strongly recommended that you contact us for an online or onsite audit. This way, if you have an inspection, you can show that you’ve checked through everything, made sure we know what we're doing, that we're doing it in an organized set-up, with all the necessary documentation ready. We offer an audit free of charge, and at a mutually-suitable time.
GAMP 5
GAMP stands for good automated manufacturing practice and GAMP 5 is a standard for developing systems for use in clinical trials.
At Viedoc, we’ve written a couple of detailed documents around this. The first one is about how we comply with GAMP 5, as there are aspects that we must comply with if the software is going to be used for clinical trials. And the second document contains things you, as the sponsor or CRO, need to think about when you run the trial in Viedoc, such as the study set up, and how you handle protocol amendments.
Book a demo with us to learn more about our eClinical solutions and how Viedoc could help you keep FDA/EMA compliant, and prepare and pass regulatory inspections.
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