Regulatory Solutions
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When Will Full Adherence To EU (536/2014) Be Required?
8/10/2022
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
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The Harmonization Of Trial Documentation Under EU (536/2014)?
8/10/2022
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
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What Do You Need To know About EU (536/2014)?
8/10/2022
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
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EU (536/2014): What Should You Know About Country Activation Cycle Times?
8/10/2022
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. See how the new regulation will streamline procedures and remove duplication of single submission.
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The EU (536/2014) CTIS Database Has Been Approved – What Happens Now?
8/10/2022
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
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Bring More Confidence To Your Post-Marketing Pharmacovigilance And Safety Surveillance
8/1/2022
Discover our records of success in PV excellence and experience so you can have certainty that our team will address your PV needs comprehensively and proficiently.
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The Importance Of A Trusted Pharmacovigilance Partner
8/1/2022
Veristat supports successful post-marketing pharmacovigilance (PV) expertise for pharmaceutical drugs, biologics, natural health products, and medical devices.
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Global Advantage With Free Trade Zones In China
7/14/2022
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
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Pharmacovigilance
7/6/2022
We support our corporate sponsors by providing both assessment and processing of SUSARS as per local and country requirements. We provide reliable reporting of adverse events, unbiased signal detection, and potential mitigation and risk management plans, based on any findings as requested.
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Mitigate Risk With Research Billing Compliance Services
6/23/2022
Ensure you are billing for clinical research confidently and in compliance with federal requirements by utilizing Advarra’s Institutional Research Center of Excellence (CoE) Consulting Services.