Synapmed currently collects cases from a variety of sources from both clinical and post-marketing stages. Our case intake activities have been digitalized; cases from different sources are compiled into our intake platform, ADRium-Intake. Cases are then seamlessly transferred to our safety database, ADRium-Safety. Drug safety professionals complete critical steps such as triage, data entry, medical review, quality check, and submission using ADRium-Safety. 

Synapmed’s medical review team performs overall ICSR assessment of properties such as case seriousness, causality, company clinical evaluation, listed/unlisted, signal identification, and MedDRA coding accuracy. 

Synapmed’s medical experts design and implement complete Risk Management Plans (RMP)and Risk Evaluation and Mitigation Strategies (REMS) for our clients products and ensure effectiveness of the risk mitigation measures. 

Synapmed’s case intake module, ADRium Intake, works dynamically and recognizes the basic criteria from the source data for ICSR validity, identifies report type (solicited and unsolicited), performs duplicate checks, identifies initial and follow-up case information, and confirms proper case registration. The case intake module allows us to populate the data elements from source data into the data entry page of ADRium safety database. 

Our case processing team efficiently works with all the stakeholders including safety partners for ICSR reconciliation, including for regulatory submissions purposes. 

Synapmed provides medical information management services to our clients for managing their medical information queries through our call centers and mailbox management team. Our team of experts can process adverse events and product quality defects received from the medical information queries for integrated ICSR case processing. 

Our pharmacovigilance experts perform case triage activities as per criteria such as ICSR validity, product identification, seriousness, causality assessments, and prioritization of cases for regulatory reporting purposes.

Our team of reporting professionals prepare and submit line listings to authorities as required for aggregate ICSR submissions.  

Synapmed’s medical writing experts have decades of experience in writing aggregate reports such as Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), Clinical Study Reports (CSR), and ad-hoc reports in response to health authority queries. Our team prepares submission ready aggregate reports including planning and kick-off of the aggregate report schedules, collection of data from different internal stakeholders, and finalization of the reports.