Pharmacovigilance

We understand the importance of ensuring the safety and efficacy of drugs,
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Pharmacovigilance

Pharmacovigilance is a crucial aspect of drug development and post-marketing surveillance. At HELIOVIGIL, we understand the importance of ensuring the safety and efficacy of drugs, and we provide a range of pharmacovigilance services to support our clients’ needs. Our team of experts has extensive experience in managing all aspects of pharmacovigilance, including individual case safety reports, literature screening, signal detection, risk management, regulatory compliance, and aggregate reporting.
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INDIVIDUAL CASE SAFETY REPORTS (ICSRs) PROCESSING

ICSRs are reports of adverse events or suspected adverse reactions that occur in patients using drugs or other medical products. At HELIOVIGIL, we provide end-to-end ICSR processing services, including initial case intake and triage, medical review, quality control, and submission to regulatory authorities. Our team is well-versed in the latest regulatory requirements and guidelines, ensuring that our clients remain in compliance. We pioneer in processing all types of ICSRs, including spontaneous reports, solicited reports, literature reports, Social Media, and Legal Cases.

LITERATURE SCREENING (GLOBAL AND LOCAL)

Literature screening involves the systematic identification and review of published literature for potential safety signals related to drugs or medical products. At HELIOVIGIL, we provide literature screening services for global and local databases, ensuring that our clients are up-to-date on the latest safety information. Our team is experienced in using advanced search strategies to identify relevant safety information from a variety of sources.

AGGREGATE REPORTS

Aggregate reporting involves the compilation and analysis of safety data for a particular drug or medical product over a specified period. At HELIOVIGIL, we provide aggregate reporting services, including the preparation of periodic safety update reports (PSURs), developmental safety update reports (DSURs), and annual safety reports (ASRs). Our team is experienced in using a variety of reporting tools, including ARISg and Empirica Trace.

SIGNAL DETECTION AND ANALYSIS

Signal detection involves the systematic identification and analysis of potential safety signals related to drugs or medical products. At HELIOVIGIL, our team of experts uses advanced statistical and data mining techniques to identify potential safety signals and determine their significance. We use a variety of signal detection methods, including disproportionality analysis, time-to-onset analysis, and cumulative summation analysis.

RISK MANAGEMENT PLANNING

Risk management planning involves the development of strategies to mitigate risks associated with drugs or medical products. At HELIOVIGIL, we assist our clients in developing and implementing risk management plans that are tailored to their specific needs. Our team is experienced in conducting risk assessments and developing risk minimization strategies, including labeling changes, educational materials, and risk communication strategies.

SAFETY DATABASE MANAGEMENT

Safety database management involves the collection, management, and analysis of safety data related to drugs or medical products. At HELIOVIGIL, we provide comprehensive safety database management services, including data entry, coding, and quality control. Our team is experienced in using a variety of safety databases, including Argus Safety, ARISg, and Empirica Signal.

REGULATORY REPORTING

Regulatory reporting involves the submission of safety data to regulatory authorities. At HELIOVIGIL, we ensure that our clients remain in compliance with all relevant regulations and guidelines by providing timely and accurate regulatory reporting services. Our team is experienced in preparing a variety of regulatory reports, including expedited reports, periodic safety update reports (PSURs), and risk management plans.

In addition to these services, our team can also assist with

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Follow-up queries and tracking
Compliance and Quality Monitoring
Independent Quality Review
SAE Reconciliations
Batch Review
Management of Bulk/bolus cases
Migration of safety data/legacy Case data
SOP writing
Training and Support
Safety Scientists and Physicians
QPPV Support
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Embark on a journey of uncompromising safety with Heliovigil's advanced pharmacovigilance services.
Your well-being is our unwavering commitment.

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