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Pharmacovigilance Safety Medicines Database

We structure, digitize and store the registration dossier data for pharmaceutical companies

OtiPharm® Data Pro Hero

We already care about our customers

OtiPharm® Data Pro

High-Tech in Pharmacy

screenshot of the system
  • Keep a register of medicines conveniently.
  • Get structured information about adverse reactions or lack of efficacy of medicines.
  • Add instructions, related documents, and any other additional information.
  • Search for literature in specialized scientific sources.
  • Your information is comprehensively protected in accordance with applicable law.

APPROACH

We solve problems:

Менеджера по фармаконагляду QPPV

QPPV

  • Collection, processing and storage of adverse reactions data
  • Receiving and sending data to the regulator in E2B R2 format
  • Literary search (one-time and regular)
  • Ability to use the latest version of MedDRA
  • Downloading the CIOMS and 137 / o forms
  • Report Tracker
Менеджера з регуляторики

Regulatory Manager

  • Saving medicine dossiers in CTD format
  • Timing monitoring of the preparation of documents
  • Regulatory Tracker
  • Reports push-reminder
Медичний директор

Medical
Director

  • Monitoring and visualization of the work of qppv and regulatory managers
  • Audit by Regulatory authority, audit of the dossier completeness in CTD format
  • Procedures monitoring
  • Reports push-reminder
СЕО, Власник

CEO/
Owner

  • Monitoring employee data entry online
  • Secure storage of all dossiers
  • Monitoring all regulatory services and pharmacovigilance procedures
  • Automatic reporting
  • Automation and optimization

System

Our main features

Обмін з ДЕЦ

Document exchange with the regulatory authority

Automatically receive and send adverse reaction messages in xml format to the regulator

Дані захищені

Your data is protected

Automatic data backup and audit trail saving

Валідована система

Validated System

The system is validated by an independent company. Validation certificate is provided at the beginning of the cooperation.

Технічна підтримка

Support

User support from 9-00 to 18-00 on business days by telephone, letters without restrictions.

Літературний пошук

Literary search

Literature search in specialized sources and automatic regular search with a given frequency.

MEDDRA

MedDRA

Latest MedDRA Guide (24.0)

Автоматизована звітність

Automated reporting

Automatic building up of PSUR and downloading in Word format.

Рівні доступу

Access levels

Fine setting up of different access levels for different categories of personnel in your company.

Аудит досьє

Dossier audit

Initial audit of the dossier during the uploading of documents into the system in CTD format.

System Implementation Steps

Otipharm® Data Pro steps

Analysis of available data, identification of customer needs

Transfer of medicine data and adverse events to the database

Intro Live Training for customer employees

Additional training as needed, training for new users

Regular technical support within the contract period

Ready to take advantage of the latest technology in the pharma industry?