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About Us

about-us

  • Expertise

    Our team combines experience in the development of technologies and data management for pharmacovigilance and clinical research studies (phases I to IV)

  • Focus on technology

    Our IT solutions include JAZZ applications, an exclusive set of software solutions, 100% developed by ANOVA and focused management of clinical and safety data of medicinal products. The applications are supported by our own technical team, providing you with innovation and constant improvements to achieve high quality standards

  • We add value to

    • Pharmaceutical/biotech laboratories
    • Contract Research Organizations (CROs)
    • Health and/or academic research institutions

  • Our Quality Policy

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PHARMACO
TECHNO
VIGILANCE

Our Jazz Safety application is a web-based database management software, oriented to meet the needs of monitoring and comprehensive management of safety reports at a local/regional level within your organization.
Download Brochure jazz_safety
AE reporting forms aimed at patients/relatives, health professionals or sales representatives. They can be operated via PC or mobile device.
Import case reports in XML E2B format
Management of case reports (initial and follow-up) through a workflow with configurable processing times
Database architecture in line with ICH E2B (R3) standard
MedDRA and medicinal product (WHODrug) / medical device coding
Validation of entered data
Medical evaluation
Export of case reports in standard formats (CIOMS-1, XML E2B) or local formats
Management of regulatory submissions to health authority and third parties.

Functional characteristics

  • Dashboard with real-time metrics
  • Automatic check for duplicate cases
  • Case tracking notices
  • MedDRA and WHODRUG C3 dictionary integration
  • Case narrative autogeneration tool
  • Electronic repository of source documents
  • Generation of standard (e.g., IPAS/PSUR) and custom reports
  • Signal detection
  • Import / Export of case reports in XML E2B (R2/R3) format
  • Management of regulatory submissions (individual case reports and periodic reports)
  • Importing acknowledgments in XML E2B format

CLNICAL
RESEARCH

Our Jazz Clinical application is a web-based electronic data capture (EDC) software aimed at meeting clinical data management needs in Phase I to IV studies, pharmacovigilance programs and patient records
Download Brochure jazz_clinical
Intuitive and easy-to-use EDC interface
Automatic validation of uploaded data
(S)AE electronic reporting form – Integrated with Jazz Safety app
Approval of CRF screens
Remote monitoring and verification of source data
Query management
Verification of CRF screens
Monitoring of safety reports (SUSAR, IND) distribution
MedDRA Coding
Data listings for monitoring and quality control (QC)
Data extraction for statistical analysis

Functional characteristics

  • Dashboard with real-time metrics
  • Mobile app for patient records (iOS, Android)
  • Randomization
  • Dispensing of investigational product
  • Inventory management of the investigational product at the local and central level
  • Mobile application for patient data capture (ePRO)
  • Module for the distribution of safety reports (SUSAR, IND) to research centers
  • Protocol deviation registration module

OTHER FEATURES

21 CFR Part 11

Our application meets the standards of traceability, reliability and security of electronic records.

Validation

Our applications are validated by our technical team.

Support
Multilanguage

User interface in Spanish, English and Portuguese languages.

Helpdesk

Technical support for users.

ANOVA

ANOVA S.R.L.

Address

Juan de Garay 580 (1153),
Ciudad Autónoma de Buenos Aires,
Argentina

Contact

+54 911 4420 0991
[email protected]

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CONTACT US

Our helpline is open to receive questions or comments. Feel free to send us an email from the form below and we will contact you as soon as possible.