| LAXAI provides comprehensive, risk based and flexible solutions for managing your product safety by providing trained and well qualified resources to gather, manage, analyze and report to regulatory agencies. LAXAI's Pharmacovigilance team is supported by Medical Writing, Data Management, Infrastructure and Regulatory teams to ensure that our clients save time and costs without compromising on quality and ensuring complete confidentiality. We provide a full spectrum of services to cater to your Pharmacovigilance needs |
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| Data Collection |
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- Call center support with 24/7 support
- Adverse Events and Serious Adverse Events data entry/ logging
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| Data Management |
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- Adverse Events and Serious Adverse Events Tracking
- Case routing/ processing
- MedDRA and WHODRL coding
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| Medical Analysis |
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- Adverse Events and Serious Adverse Events analysis
- Serious Adverse Events narrative writing
- Medical review and signal detection
- Literature reviews
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| Regulatory Reporting |
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- Medwatch/ CIOMS form generation
- Preparation of Periodic Safety Update Reports (PSURs)/ Periodic Adverse Drug Experience Reports (PADERs )
- Prompt notification of Suspected Unexpected Serious Adverse Reaction (SUSARs)
- E2B electronic reporting format generation
We support major platforms such as Oracle AERS, ARGUS and ARISg. |
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| Engagement Models |
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| LAXAI provides both technical as well as operational resources who work as a part of Drug Safety and Pharmacovigilance teams at the client location. We provide outsourcing options by providing the flexibility to outsource specific functions such as Data Collection or Management either to our offsite facility in the US or a blend of offsite and offshore operations with teams deployed at onsite, offsite and offshore across India and US. |
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