Adverse Event Management
Educe offers a cost-effective adverse event management system. We manage the legacy safety data and company's future needs for processing individual case safety reports.
Educe Solutions offers you complete service for case management which comprises of collection of safety relevant data by literature search, assessment of suspected ADRs from the literature, competent authorities and the spontaneous reporting system as well as electronic reporting.
Adverse event management is an end to end system and includes case triage, data entry, quality control, MedDRA coding, medical review, reportability assessment, regulatory reporting and follow-up. Our experienced pharmacovigilance physicians are involved in reviewing MedDRA coding and quality check of all cases.
The core processes and services include:
- Adverse Events and Serious Adverse Events logging, data entry
- Adverse Events and Serious Adverse Events case processing
- Serious Adverse Events narrative writing
- Safety medical assessments by the physician
- Expedited reporting according to regulatory requirements
- E2B electronic reporting format generation
- Literature search and reviews
- Management of follow-up cases
- Compliance monitoring and QC
Aggregate Reports Management
Benefit Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs) are a valuable source of pharmacovigilance data for the competent authorities. The MAHs should review the safety profile of their products and ensure that the Summary of Product Characteristics and Package Leaflet are up to date. The competent authorities plays great importance on compliance with periodic reporting.
At Educe we have years of experience in planning, write-ups and submission of safety reports.
- PBRER/PSUR strategy and procedures
- Preparation of Periodic Safety Update Report
- Preparation of Addendums and Summary Bridging Report
- Pharmacovigilance Physician review
- Management of PSUR reporting requirements
- Training of Client personnel in PBRER/PSUR handling, management and reporting
Signal Detection and Analysis
Signal detection is a key component of pharmacovigilance and the whole process of risk/benefit evaluation depends on the effectiveness of signal management system
Educe's proactive signal management system
Educe provides companies with:
- Signal Detection and analysis for the products
- Review of current signal management practices
- Assess Individual case and aggregate reports for signal evaluation
- Medical monitoring of safety signals on a monthly or quarterly basis
- Data mining signal detection tools
- Drug Safety Algorithms (DSAs)
Safety Risk Management
Safety Risk Management and assessment of risk-benefit balance is crucial both in clinical development and post marketing safety of medicines. Risk minimization involves minimizing a product's risk while preserving its benefits.
USFDA requires a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
Educe provides companies with the following Risk Management and support services.
The core processes and services include:
- Risk Management consulting
- Preparation of communication plan
- Risk Management plan
- Routine risk minimization activities
- Risk Evaluation and Mitigation Strategies (US-REMS)
- European Union Risk Management Programs (EU-RMP)
- Post-marketing requirement studies
- Observational studies
- Epidemiology studies
- Safety-surveillance studies
Medical/Scientific Literature Search
Regular monitoring of worldwide medical and scientific literature forms an integral part of the ongoing safety surveillance of products.
At Educe, we perform:
- Weekly/Ongoing Literature search
- Identification and management of safety related data
- API/Product Specific Literature Search
- PSUR Literature search and analysis
- Identification of ICSRs in reports
Quality and Compliance
Quality systems should be in place for all the pharmacovigilance activities to ensure effective monitoring of compliance and the accurate and proper documentation of all the measures taken.
Educe helps companies to establish and follow a quality system that is adequate and effective for performing pharmacovigilance activities. It covers the responsibilities, procedures, processes and resources and includes appropriate resource management, compliance management and record management.
Performance indicators are used to continuously monitor the performance of pharmacovigilance activities in line with the implemented quality system.
At Educe our compliance activities include:
- Regulatory audits and inspections
- Record management and Data retention
- Pharmacovigilance Operations compliance
- Standard Operating Procedures compliance
- Training and standards compliance