A wide range of Clinical Safety services.

Arriello’s Clinical Safety services can provide a faster, better, smarter solution to your setup, documentation, reporting, submission and ongoing clinical trial management needs.

Arriello Clinical Trials

Arriello’s Clinical Safety services.

The outsourcing of a wide range of Clinical Drug Safety activities and guidance is now a widely accepted, approved and in-demand practice.

To bring our years of expertise, reputation and faster, better, smarter service ethos to this fast-growing area, Arriello has created a significant investment and development program in Clinical Safety services to meet the needs and expectations of current and prospective clients, such as sponsors and CROs that run clinical trials.

 

The clinical safety timeline.

The clinical safety timeline.

Arriello offers Clinical Safety services in those areas marked in yellow.

Establishment and maintenance of sponsor drug safety projects.

At the start of your trial, we can provide a range of setup services to make the whole process faster, better, smarter.
A correctly set up project can save you time, money and ensure that all the phases of the trial are robust and efficient.

EV Responsible Person
We can provide the EV Responsible Person for SUSAR reporting to the EMA's Eudravigilance system.

24/7 drug safety contact point
We can provide the contact point for the reception of SAE/SUSARs from the clinical center/investigator.

Creation of reporting instructions for clinical centers
We can draft all SAE/SUSARs reporting instructions for Clinical Centers and the Sponsor or Sponsor representative.

Drug safety and reporting training
We can develop all your training materials for your investigator and clinical staff.

Clinical trial documentation review
We can provide a full review service for all your protocols, contracts, final reports etc.

Safety management reporting plans – preparation and review
We can draft your drug safety plan to manage all your trial drug safety information.

Eudravigilance Clinical Trial Module registration
We can provide a full registration service with the Eudravigilance Clinical Trial Module.

Case management.

We work alongside the assessments from your Clinical Trial Principal Investigator, and together with our own assessments, process all documentation and safety database entry.
We also handle all authority submissions and ethic committee communications on your behalf.

SAE/SUSAR processing
We can provide a full reporting and expedited reporting service for all your SAE and SUSAR reports.

MedDRA coding
We can provide a complete MeDRA coding service for the submission of case reports.

Global Safety Database management
We can provide a complete Safety Database management service including its establishment, ongoing maintenance and all reconciliation with the Clinical Database.

Aggregate/annual safety reports.

Whatever your safety reporting needs throughout the duration of your trials period, we can handle it, faster, better, smarter.

DSUR processing
We can provide a full DSUR writing service.

Other services.

Submissions and documentation
We can provide a full documentation Submission service to all Local Authorities and Ethic Committees.

Download our Clinical Safety services brochure.

 

You'll find all the key information about our Clinical Safety services in our brochure, which you can download here.

Are you looking for support with your clinical trials study?

Find out how we can provide a faster, better, smarter Clinical Safety solution. Just fill and send the form and we'll be in touch, it's easy.