ICSR Case Management.
What global and local Case Management services can we provide?
Arriello provides full support for each step of your global and local Individual Case Safety Report (ICSR) case processing, including end-to-end case processing of all your non-interventional ICSRs and Clinical Trial SAEs, and other reportable adverse events of special interest.
We handle all the MedDRA and WHO Drug coding, case assessment, and proactive case follow-up to electronic case submission onto the EMA, MHRA, FDA, etc., plus local case submission as required to all concerned parties.
From collection and translations through to data entry, quality control, medical review, regulatory submission to concerned parties, and case follow-up, we’ll manage your safety data and meet all your ICSR case processing requirements.
We can also provide access to our fully validated CFR 11 compliant Veeva Vault Safety database, assuring complete transparency across the case management lifecycle, and with custom dashboards to monitor the workflow and agreed Key Performance Indicators (KPI).
What about Data Entry and Quality Control?
Our experienced team ensures cases are processed in a fast, efficient, risk-prioritised manner through our safety database workflow and dashboards, with cases managed according to our client-agreed Safety Management Plans and timelines.
We process all relevant data from available source documentation according to robust data entry conventions which are aligned to your needs. We employ a risk-based approach to the generation of follow-up queries, and coordinate across stakeholders to ensure the reporter receives a consolidated request for additional information.
All case reporting is subject to independent and documented Quality Control to ensure correct data entry and the promotion of continuous improvement within the Safety Data Management team.
MedDRA coding.
We provide a complete and up to date Medical Dictionary for Regulatory Affairs (MedDRA) coding service for the processing of all your pharmacovigilance case reports.
In addition to MedDRA coding, we employ lookups for ‘always-serious’ lists including Important Medical Event (IME) and Designated Medical Event (DME) lists, as well ‘auto-expectedness’ lookups to ensure consistency in coding and assessment whilst reducing the risk of error.
Medical review.
Our experienced safety physicians can assess all your case reports which includes:
- Review of the MedDRA-coded terms
- Case narrative and company comment
- Company/Sponsor Causality Assessment.
This can be done independently from your operations, or in close collaboration with your in-house safety physician or medical monitor.
Fast and efficient ICSR reporting with automation.
Through our world class regulatory intelligence processes, and automated processes within our Veeva Vault Safety database, our team can report ICSRs globally to the EMA, FDA, MHRA, etc., using relevant submission gateways and portals.
We are experts at preparing expedited safety reports, including cover letters, electronic submission, and local submission of SUSARs and IND Safety Reports to Competent Authorities, Ethics Committees/IRBs and Investigators, as per applicable regulatory reporting requirements.
Translations to and from local languages.
Clear and accurate communication is critical when dealing with clinical safety data and we can handle all translations to and from local languages as part of the case management process e.g., autopsy reports.
Safety mailbox management.
We can monitor, assess, track, process and forward any correspondence and information received in a local safety mailbox.
Reconciliation services.
We reconcile with applicable sources and 3rd parties including business partners, Medical Information and Product Quality, and we support any ongoing or final reconciliation between the Clinical and Safety Databases working together with your Clinical Data Management team.
Selected Case Studies.
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I have to say that everything has been really smooth with Arriello, and your team has shown a really good disposition since the beginning. Your big experience and knowhow are very important for us also.
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.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
Arriello has been truly committed to meeting our needs and providing us with guidance and recommendations along every step of way. We have now been using Arriello for approximately five years and are extremely satisfied with our choice.