Call Center, Homecare Programs, Adverse Event Reporting


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Served More Than 130 International And Regional Clients, Preparing More Than 100 Ctds, 20+ Patients Support Programs Serving 500+ Patients In More Than 5 Theraputic Areas And 15+ PV Consultancy Projects In 20 Regional Countries. Clinfo1t Has Handled More Than 30 Study Designs, Protocols, CRF Development, Data Management, Statistical Analysis Performance/Reports, Data Cleaning, And Clinical Study Reports And 50+ Publications.

Pharmacovigilance

Pharmacovigilance System Setup
Literature Screening
Regulatory Intelligence
LQPPV Services
Documents Preperation – SOP , ICSR , PSUR & RMP
PSMF Preperation And Maintenance
Epv

Medical Writing

Synopsis Writing
Protocol Writing
Informed Consent Form (ICF) Writing
ICF Translation
CRF Translation
Medical Translation Services
Clinical Study Report (CSR) Writing
Manuscript Writing
Serious Adverse Event (SAE) Narrative Writing
CTD Writing & E CTD
Advisory Board Mom Reporting

Data Management

Etmf
Database Design
Database Quality Check And Validation
Data Management Plan
Randomization Programming And Validation
CRF / Ecfr Design And Development
CRF Completion Guidelines
Data Entry
Coherence Control Between Entries
Discrepancy Management & Query Processing
Safety Reporting
Saes Reconciliation
Electronic Data Capture (EDC) Support
Close Out Phase: Quality Check And Database Lock
Interim Database Cleaning
Database Cleaning
Interim Data Transfers
Data Management Report

Biostatistics

Sample Size Calculation
Statistical Analysis Programming And Validation
Interim Statistical Analysis Performance
Statistical Analysis Performance
Statistical Report

PSP

Vigilance : Nutri Vigilance

Big Data Management: Data Mining