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iSafety is a global leader in assisting life science companies, to accomplish their pre-clinical to clinical and post-marketing doings. iSafety offers a comprehensive and fully integrated stack of scientific solutions, platform services and engineered systems.
Since 2008, our industry-leading solutions give customers complete deployment flexibility and unmatched benefits including solution integration, advanced security, high scalability, business agility, reduced complexity and low total cost of ownership.
- Clinical Drug Safety
- Regulatory Services
- Global Labeling Management
- Medical Information
- Clinical Data Management & Statistics
- Toxicology Services
- Publishing & Submission
- Artwork And Pack Management
- IT Solutions
- Support Services
- Adverse Event Management
iSafety offers a cost-effective adverse event management system. We can manage your legacy safety data and your company's future needs for processing individual case safety reports.
iSafety 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.
iSafety SegreGATE TM : Our Segregation Model allows companies to outsource certain activities and processes to better utilize their in-house team time and resources.
The core processes and services include:
- Adverse Events and Serious Adverse Events logging, data entry
- Adverse Events and Serious Adverse Events case processing
- MedDRA and WHODRL coding
- Serious Adverse Events narrative writing
- Safety medical assessments by the physician
- Generation of forms - CIOMS/Medwatch
- 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 place great importance on compliance with periodic reporting.
At iSafety we have years of experience in planning, write-ups and submission of safety reports. We help companies to meet their needs within the defined time frames.
- 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
With the ever increasing scrutiny by regulatory authorities and public, the companies need to strengthen their signal management systems. The expectations for rapid identification and prompt management of emerging drug safety issues have grown significantly.
Signal detection is a key component of pharmacovigilance and the whole process of risk/benefit evaluation depends on the effectiveness of signal management system.
The Competent Authorities can request these documentations at any time which requires the proactive safety evaluation and reporting processes to be working efficiently.
iSafety's advanced proprietary proactive signal management system.
ISignalProTM works in accordance with the FDA and EMA recommended best practices for identifying, evaluating, investigating and interpreting safety signals
ISignalProTMidentifies new risks or a change in risk associated with an active substance or a medicinal product.
ISignalProTM applies advanced data mining techniques to a variety of spontaneous reporting databases.
ISignalProTM covers all steps from detecting signals, through their validation and confirmation, analysis, prioritization and assessment to recommending action, as well as the tracking of the steps taken and of any recommendations made. ISignalPro TM 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.
iSafety 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
Medical/Scientific Literature Search
Regular monitoring of worldwide medical and scientific literature forms an integral part of the ongoing safety surveillance of products.
At iSafety, 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.
iSafety 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 iSafety our compliance activities include:
- Regulatory audits and inspections
- Record management and Data retention
- Pharmacovigilance Operations compliance
- Standard Operating Procedures compliance
- Training and standards compliance