A wide range of Clinical Safety services.

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.

Arriello Clinical Trials

Why choose Arriello?

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.

Faster

High-quality results, delivered on time. Flexible, adaptable, and end-to-end solutions.

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.

Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.

Timothy R. Roe
KalVista Pharmacovigilance Consultant

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 dedicate an experienced Clinical Safety Project Manager who will be your main point of contact throughout the set-up and maintenance of the services in scope. They are responsible for organizing and moderating kick-off meetings and regular status meetings to guide you through the project plan development, monitor project progress, support budget monitoring and more.

Additionally, our technical team will consult you on the optimal set-up for the safety management of your trial and will consolidate this in your trial-specific Safety Management Plan. A correctly set up project can save you time, money and ensure that all the phases of the trial are organized, executed and documented in a compliant manner.

EV Responsible Person
We will guide you through Sponsor/Product set-up and maintenance of the EudraVigilance system, and manage the transfer of the Responsible Person, as applicable.

Safety Management Plan
We will consult you on the best way to set up the safety management of your trial, taking into consideration the study phase, indication, study population, other parties involved in the trial execution and budget. The safety management approach will be described in the safety management plan.

We will prepare and review your safety management plan, with all associated forms (including business contingency plan for SAE/SUSAR reporting) to manage all your trial drug safety information.

Drug safety and reporting training
We will prepare all your trial-specific Clinical Safety training materials and conduct applicable training for respective personnel at the study sites during Site Initiation Visits and Investigator Meetings. We can also advise on how to improve the efficiency of your Investigator Meetings, and ensure you have the appropriate content to make it successful!

Clinical Trial documentation review
We understand the criticality of having a thorough protocol prior to study initiation, thus we can advise you on the best approach to set-up the safety section during protocol writing and finalization.

In addition to your protocol, we involve our consultants in providing a full review of your reference safety information (e.g. as part of the Investigator’s Brochure), contracts, final study reports, etc.

Safety Database set-up and maintenance
We can provide safety services in our validated in-house safety database, or we can adapt to the safety database of your choice. With our in-house option, we provide a complete safety database management service including establishment and ongoing maintenance.

Case management.

End-to-end Serious Adverse Event (SAE) processing
We provide complete end-to-end case processing of all your SAE and other reportable adverse events of special interest.

Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting
We appoint a dedicated person responsible for SUSAR reporting globally, as applicable (e.g. in EMA’s EudraVigilance system, MHRA portal, etc.). We are experts at preparing expedited safety reports, including cover letters and global EV and non-EV submission of SUSARs to Competent Authorities, Ethics Committees and Investigators, to the relevant regulatory intelligence reporting requirements.

Medical Dictionary for Regulatory Affairs (MedDRA) coding
Coding in MedDRA is mandatory in most regions worldwide, and we provide a complete up-to-date MedDRA coding service for the processing of all case reports.

Medical review
Our experienced safety physicians can assess all your reported SAEs and SUSARs. This includes narrative review of MedDRA coded terms and determination, and documentation of the Sponsor Causality Assessment. This can be done independently from your operations, or in close collaboration with your in-house safety physician or medical monitor.

Medical monitoring
We provide medical monitoring from protocol writing to final analysis throughout your trials, and are available 24/7 as needed to answer medical queries from sites (e.g. inclusion and exclusion criteria).
Our medical monitors are experienced physicians and will monitor the study data closely for medical accuracy and identify and escalate any trends to the sponsor that potentially impact patient wellbeing and safety, including any events of special interest.

Translations to/from local languages
Clear and accurate communication is critical when dealing with clinical safety data and we can handle all translations to/from local languages as part of the case management process (e.g. autopsy report).

Reconciliation services
Following the Reconciliation plan, we support any ongoing or final closure reconciliation between the Clinical and Safety Databases, together with the Clinical Data Management team.

Aggregate/annual safety reports
We will guide you through all applicable aggregate and annual safety reports throughout the duration of your trials period, and support you with the drafting, reviewing and submission of these applicable reports.

Development Safety Update Report (DSUR) preparation and submission
The DSUR includes a comprehensive overview of your medicinal product’s benefit-risk evaluation and compliance with applicable regulations. We provide a full DSUR writing and submission service with our dedicated medical writing team to guide you through production and submission.

Line listings/periodic reports
We prepare all SAE Line Listings, biannual Line Listings, frequency tabulations, and trend reports, as applicable. We can also propose additional solutions and customizable reports that fit your scope.

Other services.

Regulatory Intelligence
To ensure you have all the expertise required to get started, we create a customized Reporting Requirements Summary Report according to your scope. Throughout the maintenance phase, we provide ongoing Regulatory Intelligence updates in response to local regulatory and legislation changes, with analysis and actions of the impacts related to your scope. Our consultants provide country-specific insights that can reduce your risk with ample forward planning to changes and implementation to mitigate impacts to your PV system or product.

Literature Monitoring
Literature monitoring is more than just a drug safety regulatory obligation, it provides insight into all safety issues and promotes the creation of all types of safety and aggregate reports. It supports the signal management process, and influences decisions that mitigate the risk-benefit balance of our product, ultimately helping to protect patients.

Our extensive experience in developing robust search strategies and the construction of broad and narrow literature queries allows us to search for published studies and information relevant to the safety of your products and your trial methodology. We ensure the efficient assessment and auditable results documentation of any available information that may impact study subject safety or require further investigation according to agreed periodicity.

Signal management
There is no one-size-fits all solution to signal management and our approach is customized to your needs to ensure that signals are fully identified and assessed in consideration of the safety profile of your products and your target population.
We provide full consultancy on navigating the regulatory landscape from the planning stages of your trial through to marketing authorisation application and the full product lifecycle requirements beyond.

Development Risk Management Plan
An effective Risk Management System together with the development and update of Risk Management Plans, mandatory in the EU, are a critical part of pharmacovigilance and patient safety. Setting-up your risk minimization strategy early in the project will ensure there are no delays in your submission of a Marketing Authorization Application. Arriello’s in-house risk management experts can identify new safety concerns as they arise and propose appropriate risk minimization measures, keeping you compliant, on budget and improving patient safety.

Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) Support
We support your DSMB/DMC activities with independent PV experts from our Advisory Board.
We provide:
• A wide range of services from Committee Charter creation to the running and management of these Committees
• PV expert membership, chairmanship, consultancy and support to identify subject matter experts and key opinion leaders

Event Adjudication
PV experts from our Advisory Board can also support you in the adjudication of important adverse events.

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.

The Clinical Safety Team, led by Alexandra, 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.

Timothy R. Roe
KalVista Pharmacovigilance Consultant

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