We provide pre-approval and Post marketing pharmacovigilance support.
Management of the safety data and adverse events in clinical trial and post marketing of pharmaceutical product is much significant throughout the product life cycle. It is required to minimize the risk associated with the clinical study and investigational drug.
We adopt an innovative approach to manage the safety data in a comprehensive and proficient manner. We provide the different efficient electronic systems which helps to increase the data accuracy and reduces inconsistencies.
We keep subject safety in the centre from clinical study conduct and post marketing and provide wide range of Pharmacovigilance services and tailored pharmacovigilance solutions after an effective evaluation and thorough industrial leading analysis to minimize the associated risks.
Pharmacovigilance for Clinical Trials
Safety Database Management
Case Management
Medical Coding
Safety Report preparation and submission (SUSAR, PSUR, and DSUR)
Global Literature Search & Review in support of the safety reporting and assessment
Investigator training on medical coding, safety reporting, and causality assessment
Reconciliation of Serious Adverse Events
Pharmacovigilance for Post-market Studies
Signal Detection
Support in Protocol development
Drafting /Review of Risk Management Plan
Literature screening
Safety reporting – ICSR and Aggregate safety reporting
Case Management including serios adverse event
Safety system and case processing
Signal and Risk analysis
Drafting /Review of PSUR
Drafting and review of Annual Report
Pharmacovigilance System Services
PV System setup and management
PV system maintenance
System Audit support
Data security and transfer
Regulatory support for Safety reporting
Support Services Outsourcing
SOP writing services
Training services
Regulatory update
Monitoring and Audits/Inspection
System outsourcing
PV Audits
Internal Audits
Training and mock inspection
Audit/Inspection Support
Vendor/Affiliate Audits
Why Haleus:
We have an in-house team of expert, dedicated and experienced PV professionals.
We use latest technology which facilitates the faster and smarter safety reporting.
Our team is expert in handling the different technology used for the safety data processing and reporting.
Our team has sound knowledge and understanding on the different regulatory requirements.
Delivering the pharmacovigilance services timely with top level of accuracy.
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