Industry Pioneers. Future Focused.
Our US, UK and European locations enable a seamlessness in getting your trial drugs effeciently to those who need them.
Global. Independent.
Ambitious.
We are a privately-held, women-owned (WOSB), multinational clinical supply management company focused on advancing science and improving patient outcomes.
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Under the previous process, known as the Clinical Trials Directive (CTD), running a multi-country trial in the EU meant the sponsor had to send a separate CTA to the competent authorities and ethics committees of each country targeted. Then each country had to authorize the trial based on its own adaptation of the CTD into national regulations, which varied between countries. Inefficient and costly, the process ultimately hindered clinical research in the EU.
Under the new Regulation, sponsors may submit a single CTA through the CTIS, which allows for parallel review by EU/EEA Member States. The CTA is a two-part dossier: Part I involves general information about the trial, and a lead Member State (proposed by the sponsor) coordinates and reports a collective response from contributing Member States; Part II involves country-specific information, and sponsors complete a Part II for each Member State concerned. Within a set timeline, each Member State concerned must notify the sponsor of its decision via the CTIS.
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Lorem Ipsum Dolor De Sit
Under the previous process, known as the Clinical Trials Directive (CTD), running a multi-country trial in the EU meant the sponsor had to send a separate CTA to the competent authorities and ethics committees of each country targeted. Then each country had to authorize the trial based on its own adaptation of the CTD into national regulations, which varied between countries. Inefficient and costly, the process ultimately hindered clinical research in the EU.
Under the new Regulation, sponsors may submit a single CTA through the CTIS, which allows for parallel review by EU/EEA Member States. The CTA is a two-part dossier: Part I involves general information about the trial, and a lead Member State (proposed by the sponsor) coordinates and reports a collective response from contributing Member States; Part II involves country-specific information, and sponsors complete a Part II for each Member State concerned. Within a set timeline, each Member State concerned must notify the sponsor of its decision via the CTIS.
Careers and Culture:
it’s our people who set us apart
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First in the Industry
We began as Simirex and were one of the first clinical packaging companies in existence. Almost 40 years later, we’re here as Xerimis – still independent and still leading the field.
Committed to the Community
We began as Simirex and were one of the first clinical packaging companies in existence. Almost 40 years later, we’re here as Xerimis – still independent and still leading the field.