ICSR Case Management

ICSR Case Management.

Peace of mind with our complete safety data management service.

What Case Management services can we provide?

Arriello provides full support for each step of 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.

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.

View all
ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
Pharmacovigilance system, Europe, Local and global PV
The client chose Arriello to be their outsource partner for all of their EU Pharmacovigilance activities, both local and global.