Symbiance is a trusted global drug safety and pharmacovigilance services partner offering safety services to biopharmaceuticals for drug, device, vaccine/biologics, and cosmetic products. We provide a one-stop solution and services for the management of adverse events, SUSARs, ICSRs, CIOMS, MedWatch and other regulatory required formats emerging out of clinical trials and post-marketing surveillance.
Our highly skilled global safety team, work in the way pharmaceutical companies have handled drug safety requirements to be compliant to the regulators. Case management procedures at Symbiance follow in-house methodologies created by our talented QA professionals. We work with systematic procedures by simplifying tasks with detailed workflow through which we can provide high-quality output and effective services at an affordable cost.
As a drug safety services provider, Symbiance aims to meet all your pharmacovigilance requirements both at the clinical stage and post-marketing.
Individual Case Safety Report (ICSR) Processing
- Handling of serious and non-serious reports from all sources.
- Intake->Triage assessment->Data Entry->MedDRA coding->Narrative writing-> Medical review->Quality review-> Submission ready-> Submission to FDA handling- systematic tracking, versioning and follow-ups.
Adverse Events (AE) Case Management
- AEs managing for cases arising from different sources.
- AEs screened from spontaneous reporting in the post-marketing surveillance, case reports from clinical trials, and published literature searches.
- Data Metrics, dashboard reports, and visualization.
Aggregate Reports- Prepare and Publish
Our expertise medical/regulatory writing team develop:
- Periodic safety reports for global regulatory authorities- PADER, PSUR/PBRER
- Offering writing support for ASR/DSUR
- Provide medical review support for other vendors written aggregate reports
- Adhoc and/or Addendum reports
- Summary Bridging Reports (SBRs)
- Drug Safety Reports (DSRs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
Signal Detection is a complex area within pharmacovigilance services which requires a high level of professional work. At Symbiance we address this challenge adeptly. We systematically, precisely track and document all special medical events that establish a signal for medical attention. Our PRR Statistical process includes:
- Assessment Strategy- Routine and proactive AE Data mining
- Screening, identifying, grading
- Validation and Confirmation
- Tracking and Trending
- Event Prioritization
- External data search and comparison
- Analysis and report
- Recommending action
Risk Management Plans-Write/Update/Maintain
Our expert team of medical doctors has strong experience in developing
- REMS – Risk Evaluation and Mitigation Strategies (For US FDA)
- RMP – Risk Management Plan (for EU)
We provide systematic literature search services from public and commercial databases like AdisInsight, Embase, Medline and PubMed for AE identification and aggregate reports.
Other Pharmacovigilance Outsourcing Services includes,
- Development of Standard Operating Procedures (SOPs)
- We help to develop SOPs related to PV processes
- Case processing procedures
- Aggregate reporting procedures
- Update and Maintenance of SOPs
With the onset of advanced technology to circumvent manual data entry errors, and speed up the decision, we are in the process of ratifying and enhancing our technologies to assist automate safety data entries from all possible safety data formats into the Databases. We work with industry best PVAI experts to help safety data is accurately and naturally captured for better decisions. Through this, we provide accurate, real-time, quality data entries for further assessments and decision making.
Our team of PVAI experts, programmers, clinical data management experts, medical professionals, drug safety experts, aggregate reporting scientists, and medical affairs personnel with our base of operations out of Princeton, New Jersey, in the United States and global delivery centers in Europe and India.