A wide range of Clinical Trials services.

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

Arriello Clinical Trials

Arriello’s Clinical Trials services

The outsourcing of a wide range of clinical 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 Trials services to meet the needs and expectations of current and prospective clients.

That services program has now started, initially offering drug safety services to sponsors of BA/BE studies in Europe and a range of other activities.

 

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.

Expert solutions, delivered.

 

Every project and client has different needs and requirements.

With our expert knowledge, communication skills and experience, combined with a deep understanding your expectations, we can bring together all these elements to create a tailored custom solution to meet and exceed those needs.

 

"Arriello can now provide high-quality drug safety services to sponsors of BA/BE studies in Europe with our team of experts. By focusing on our client’s needs and expectations we earn their confidence every day."

Diná Campos
Head, Full Pharmacovigilance System and services

Dina Campos Clinical Trials Services Leader

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.

Are you looking for support with your Clinical Trials study?

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