Future of Pharmacovigilance

AI Drug Safety Reporting

•  Simple step from paper-based forms to cloud solution

•  Works with all common Pharmacovigilance databases

•  ICH E2B R3. MedDRA & WHODrug support

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Safety reporting made easy

Medical liaisons, doctors, pharmacists, patients & caregivers can send report directly to pharmaceutical company and regulators.

Timely & with zero effort.

PASS-through the value
‍
Cost-effective Post-Authorisation Safety Studies.
Collect reports directly from patients.

Switch to Quality
‍
Save time & resources.
Provide clean and validated data.
You can work in your template & stay compliant.

The first unified solution for massive safety case intake

Continuity

Multidevice support

You can pause work at any moment and then continue at the same field. Even on another device

versatility

Offline reporting

XML, CIOMS & PDF formats automatically generated for downloading and forwarding

conformity

Regulatory submissions

Crucial option to send safety reports directly to regulatory electronic gateways

147.3%

average increase in ICSR reporting

5600+

number of ICSRs received from mobile apps

45%

professionals noticed uptrend in cases*

*Fukushima, A., Iessa, N., Balakrishnan, M.R.et al Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience. BMC Med Inform Decis Mak22, 118 (2022)
Compliance

Validation Matters

•  PV.app is validated in accordance with GAMP5
•  GxP & 21 CFR P.11 (Annex 11) compliant
•  User Acceptance and Training support

security

Data Confidence

•  Redundant cloud storage solution, audit trail ‍and backups
•  Certified data-centers located in Asia, Europe and North America
•  Secured data processing standards following GDPR & HIPAA

Activity & Feedback Notifications

Notifications about new ICSRs & AE assessment results

MedDRA & WHODrug Dictionaries

MedDRA & WHODrug dictionaries make the case well prepareddesigner

Embedded hint system

Hints: tips & manual for populating of each field in the form

mission

Provide top-tier patient care

by sharing safety information in the most effective and efficient way between Pharma, healthcare professionals & patients, enjoying their experience

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Contacts

Let's keep in touch:

‍•   +65 3 1251710
‍‍
•   contact@pv.app
‍
•   68 Circular Road, Singapore

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•   Join us in LinkedIn

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Do you need any help with the reporting?
Feel free to send the request: support@pv.app

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