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4 Total results for product and free and sample content found

TrialScope Disclose

CTIS Best Practices Whitepaper

16 Jun 2022

CTIS Best Practices Whitepaper

Europe’s new Clinical Trial Information System (CTIS), created by the European Medicines Agency (EMA), is due to be implemented in January 2022. Find out what sponsors must do to ensure compliance with this far-reaching new regulatory requirement.

Topic Clinical Trials

TrialScope Disclose

Clinical Trial Transparency Policy

07 Feb 2022

Clinical Trial Transparency Policy

Disclosure requirements are numerous and ever evolving. Study sponsors need a transparency policy that addresses disclosure, transparency, and data sharing.

Topic Policy & Regulation

TrialScope Disclose

Téléchargez votre livre blanc gratuit, « Compte à rebours du nouveau règlement européen sur les essais cliniques : à quoi s'attendre et comment se préparer »

11 Jan 2022

Téléchargez votre livre blanc gratuit, « Compte à rebours du nouveau règlement européen sur les essais cliniques : à quoi s'attendre et comment se préparer »

Des changements majeurs arrivent, impactant toutes les étapes des essais cliniques, y compris les essais nouveaux et en cours – êtes-vous prêt ? Sachez à quoi vous attendre et comment maintenir votre conformité en matière de divulgation lorsque le nouveau système d'information sur les essais cliniques (CTIS), créé par l'Agence européenne des médicaments (EMA), entrera en vigueur.

Topic Business Strategies Clinical Trials

TrialScope Disclose

Clinical Trial Information System (CTIS)

14 Sep 2021

Clinical Trial Information System (CTIS)

Created by the European Medicines Agency (EMA). Stakeholders will use CTIS to: Submit and approve clinical trial applications (CTAs), Submit trial reports, results and notifications, Communicate centrally with the Member States Concerned (MSC) in the clinical trial

Topic Policy & Regulation Clinical Trials Clinical Trials Blog

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