Synowledge segments the process of adverse reporting for pre- and post-marketing cases into four steps: Case Intake, Case Processing, Medical Assessment and Distribution/Submission
Intake
Our case intake process reduces the number of subsequent queries, classifies events appropriately, and increases the speed of case processing and regulatory reporting. Our intake process includes:
Receipt, and confirmation of receipt, of information regarding serious and non-serious adverse events from multiple sources including investigator sites of clinical trials, healthcare professionals, consumers, literature databases and sales representatives
Documentation of adverse event reports in a validated Safety database
Triage and reportability assessment by Healthcare Professionals per current regulatory reporting requirements
Case tracking to ensure timely completion within mandated regulatory timelines for expedited reports/SUSARs submission.
Processing
Reported data is efficiently entered into the safety database in adherence to governing data entry conventions
MedDRA Coding of reported primary diagnosis and comprehensive coding of all events;
WHO-DRL/DD Coding of reported suspect and concomitant medications
Active query, forwarding of queries, and follow-up: a healthcare professional communicates directly with the investigator, or other reporters, to gather information to best qualify the individual case safety report, and supply our clients with accurate medical evaluation and assessment. Our safety specialists continually assess new information to ensure that regulatory reporting requirements are met and maintained
Detailed and accurate Case narratives are prepared for clients
Quality Checks(QC) are performed by a qualified Healthcare Professional
Adverse events are coded in MedDRA
Concomitant medications are coded in WHO Drug Dictionary (as needed)
The case narrative is prepared
Quality checks are performed by a Healthcare Professional against the source documents
Active case/query follow-up
Assessment
1st Line Medical Review: Medical Officers review the case to ensure medical accuracy, proper documentation of coded events, comprehensive descriptions of the narrative, and company causality assessment. {Medical Officers will also query for additional follow-up information which may add to the clinical significance of the report}
Individual ICSR Signal Screening: Medical Officers perform detailed review of ICSR for single case signal alert qualification
1st Line Signal Detection: Medical Officers perform routine safety surveillance and 1st line signal detection to help identify developing safety signals
Qualifications for regulatory reporting are verified
Forwarding to Sponsor for 2nd Line Medical Review and approval (if required by client)
Distribution
Sponsor regulatory authority submission
IND Investigator Notification (where applicable:)
IND Investigator Notification (EU/Europe)
Final reports are sent to the sponsor
Quality Assurance
Routine Quality Assurance (QA) procedures ensure that our services adhere to governing SOPs, regulatory guidelines, and overall corporate pharmacovigilance policies. Synowledge QA procedures :
Conduct internal audits
Apply an Internal Quality Audit checklist while performing audit
Plan, conduct and document trainings on ICH GCP, SOPs and Regulatory Guidelines prior to project task delegated
Maintain and update employee-training certifications and records
