This service area entails the processing of individual case safety reports (ICSRs) originating from various sources:
1. Post-marketing non-solicited/Spontaneous reports
2. Clinical reports
3. Special reports (Medico-legal, Literature & E2B)
4. Related services
Following established guidelines, data from source documents sent by clients is processed (data entry and MedDRA coding) in to a Drug Safety/Pharmacovigilance database, after a duplicate search, on behalf of the clients. This may involve an initial triage and a subsequent medical review/assessment of the report by physicians. Once finalized, the case reports are submitted to the regulatory authorities/business partners. Synmeta LLC’s scientists have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases. Synmeta LLC also has expertise in processing adverse reactions reports from veterinary medicinal products (veterinary pharmacovigilance) across different therapeutic areas.

These can be serious or non-serious event reports from the following sources, originating after a product has been marketed by the Marketing Authorization Holder (MAH) and does not originate from a study or any organized data collection scheme: • Regulatory Authorities/Government Agencies • Health care professionals • Consumers • Industry • Hospitals • Academia • Medical and Pharmaceutical Associations • Poisons and Medicines Information Centers • Media Both serious and non-serious event reports are processed by Synmeta LLC.

These can be serious or non-serious event reports from the following sources, originating after a product has been marketed by the Marketing Authorization Holder (MAH) and does not originate from a study or any organized data collection scheme: • Regulatory Authorities/Government Agencies • Health care professionals • Consumers • Industry • Hospitals • Academia • Medical and Pharmaceutical Associations • Poisons and Medicines Information Centers • Media Both serious and non-serious event reports are processed by Synmeta LLC.

Medico-legal/Litigation reports: These are case reports originating from filed lawsuits, forwarded to Synmeta LLC typically by the MAH’s legal department, and contain a list of damages (events that are the subject of the legal action). The source documents includes plaintiff facts sheets, medical records, e-mail communications, jury trial demand notifications, deficiency letters and summons etc. Literature reports These are case reports where an adverse event associated with a marketed or investigational product has been generated from a systematic search of commercial scientific databases of published peer-reviewed journal articles. In these, only a generic name of the marketed or investigational product may have been reported, and quite often the manufacturer cannot be determined. Translation of literature abstracts, articles and other safety data from various foreign languages to English is also offered . Literature search and review services are also offered. E2B reports These are case reports from E2B gateway transmission between MAH and regulatory authorities/business partners. The processing of such individual reports includes identification and structuring of standard data elements which are missed during electronic transmission following ICH electronic standards for the Transfer of Regulatory Information (ESTRI).
Related Services

Synmeta LLC also offers ‘stand-alone’ services to clients, as required. Medical Review/Assessment Review of a processed case by a physician or a healthcare professional to confirm the medical cohesiveness of data that is to be submitted to health authorities. Also includes the assessment of labeling that has been added by the case processor, and the checking of the narrative and CIOMS comment to ensure that it makes medical sense. All missing medical information is requested at this stage. Medical Triage Review of individual case reports received from clients by healthcare professionals and physicians to check for proper classification, assessment of their priority and compliance timelines. Priorities depend on the seriousness of the event, causal relationship and the product involved. Serious Adverse Event (SAE) Reconciliation Projects Reconciliation of SAE data between the clients’ Drug Safety (or Pharmacovigilance) database and their relevant clinical databases.Reconciliation is performed to assure that serious events are accurately captured, interpreted, and consistently reported to regulatory authorities. This comparison may be facilitated by the use of automated comparison tools. The discrepancies noted between the two databases are determined and documented, since these may ultimately require correction. Veterinary Adverse Events Reports Processing of adverse reactions reports (animal AEs, human AEs, environmental AEs and residue AEs) associated with veterinary medicinal products that occur in animals across different therapeutic areas. Ad-hoc Projects At a Glance • Back-log clearing • Correction of historical/legacy cases • Data entry of legacy cases • Data entry of line listing reports • Data migration • Data correction and clean-up projects • End-of-study blind break (EOSBB) projects • Inactivation/deletion projects • New pilot projects