Clinical Safety Overview.
Why choose Arriello?
Arriello’s Clinical Safety services provide a faster, better, smarter solution to the clinical trial safety management needs of study sponsors worldwide, including the areas of Biotech, ATMP and Biologics/Biosimilars.
Our team of experienced clinical safety consultants can guide you towards cost-effective, fit-for-purpose solutions that fit the nuances of your clinical trials while maintaining the necessary compliance to regulations.
We continue this level of support throughout the life cycle journey of your products beyond Clinical Safety by consolidating Pharmacovigilance and Regulatory activities to bring your products to market and keep them there.
Download our Clinical Safety services brochure…
Faster…
Our clinical safety consultants are focused on delivering high-quality results, on time, every time.
Their aim is to provide flexible, adaptable, end-to-end solutions that match your needs.
Better…
A dedicated point of contact to makes sure the agreed level of communication is in place throughout the set-up and maintenance of all our services, creating a relationship based solidly on trust, transparency, and strategic collaboration.
Smarter…
Our clinical safety pharmacovigilance automation technology can drastically improve efficiency, accuracy and reduce costs while maintaining compliance.
The Clinical Safety timeline.
Our Clinical Safety services in detail.
- SUSAR & SAE intake, processing, reconciliation, and reporting.
- Perform Analysis of Similar Events (AOSE).
- Generation of Monthly Case Line Listings.
- Provision and management of the safety database (Veeva Vault).
- DSUR preparation and submission.
- Local Clinical Regulatory Intelligence gathering and triage.
- SPOR and EudraVigilance registration.
Case studies.
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What our clients say about us.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
...I would also like to take this opportunity to thank Arriello and specifically Peter who has stepped into this role in a challenging time for Theramex and with his guidance helped us build our own PV system.
The Clinical Safety Team has progressed the project in a proactive and deliberate manner. We are impressed with the effort, communication and the attention to the smallest details ahead of each meeting, each invoice and every interaction. Any serious executive concerned with the success of their portfolio should be so lucky as to surround themselves with Arriello-type care.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.