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services overview

Fusionlife Solutions is an emerging CRO giving end-to-end solutions in Pharmacovigilance. We offer an extensive variety of services in Safety and Risk Management which includes state of the art call centers, case preparing and processing, well being reports of individuals, total safety detailing reports, signal detection and risk administration and management, and counseling all in support of our customers pre-advertise improvement and post-marketing exercises. Our group of researchers, clinicians, and medicinal consultants masters in assessing risk and appraising risk. Applying imaginative advancements alongside its therapeutic mastery, Fusionlife Solutions imparts a firm duty on quality for its worldwide customers and accomplices bringing about better, enhanced results in a cost-productive manner.

Expert Team in Pharmacovigilance.

Our pharmacovigilance team is comprised of industry professionals with deep-experience in both direct patient care and industry-specific pharmacovigilance services, enabling us to deliver safety data of the highest quality. Working globally, Fusionlife Solutions can provide integrated or standalone services to support product safety monitoring in compliance with regulatory requirements for safety surveillance in pre and post-approval settings.

ICSR Case Management

Post-Marketing Reports
Clinical Reports
Medico-Legal, Literature, E2b reports
Case triage and review
Data entry and MedDRA coding
Adverse Event Labeling
Narrative writing
Medical Review
SAE reconciliations
ICSRs and submissions
Safety Database hosting
Legacy case transfer
24/7 AE call center

Aggregate Reporting

PSURs/PBRERs and PADERs
ASR, DSUR
Signal Detection
Ad Hoc Reports
Generation of listings
Integrated summaries of safety
Regulatory report submissions to appropriate authorities
Medication error and drug abuse/misuse reporting
COs and ACOs

Safety/IT Enabled Services

Designing & development of global safety data repository, post migration & integration of safety data
Implementation, validation, maintenance & upgrade of Argus applications
Integration of medical dictionaries to Argus application
Design, development & submission of regulatory, operational, analytical & custom reports
Validated and up-to-date case processing platform in a secure environment.
Infrastructure hosted on cloud and maintained by Fusionlife Solutions
Training on Argus

Literature Search and Review

Literature searches
Review of abstracts and articles
Full text articles procurement and translation
Signal detection and analysis
Adhoc or customized literature searches to meet specific needs

Signal Surveillance Activities

Ongoing medical review and analysis of cases
Aggregate analysis, including data mining
Meta-analysis of published safety data
Qualitative and statistical signal detection
Signal evaluation, assessment and reporting
Development of risk management and communication plans

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