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Medical Writing

Clinical Data Management

QMS: We provide the gold standard in electronic quality and document management systems to streamline processes, templates, forms, checklists, trainings, records, assessments etc. consistently enhancing productivity while exceeding their expectations. We align with the organizations purpose and strategic direction to provide the utmost of satisfaction.

EDC: We provide a cost effective, advanced solution that manages your clinical data. This in turn allows for a better understanding of the study through reporting and metrics tailormade to fit the needs of that trial.

Training

  • Introduction to Pharmacovigilance
  • Basics of Pharmacovigilance
  • Pharmacovigilance Regulations
  • End to End ICSR Case Processing
  • Aggregate Report
  • Signal Detection and Risk Management
We are also partnered with Temple University for their Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy

scientific support

KOL MANAGEMENT
  • KOL Identification
  • Faculty/ Participants Liaison

SCIENTIFIC MANAGEMENT
  • Scientific modules
  • Meeting minutes
  • Executive summary
  • Post-meeting consensus
  • Transcription

we WILL HELP YOU BRIDGE THE GAP