Frequently Asked Questions (FAQ)

Pharmacovigilance and social media monitoring with evalii® – all answers at a glance
General
How it works
Use cases
Compliance & Safety
  • What is evalii®?

    evalii® is a managed service for automated monitoring of digital communication channels with a focus on pharmacovigilance, social media monitoring, moderation, and community management. It supports pharmaceutical companies in efficiently meeting regulatory requirements and ensuring secure digital communication.

  • Who is evalii® intended for?

    evalii® is aimed at pharmacovigilance teams, but also at marketing and communications departments that need to manage social media activities in compliance with the law and at the same time respond to PV-relevant content.

  • Which languages and markets does evalii® cover?

    evalii® supports content in 28 languages and is suitable for international campaigns and brand appearances – including specific requirements in the EU, the USA and other regions.

  • Is evalii® also suitable for international markets and teams?

    Yes. evalii® is specifically designed for international use. We monitor content in 28 languages, taking regional regulatory requirements (e.g., EU, FDA, MDR) into account. Our moderation and PV workflows are multilingual and scalable and can be rolled out worldwide – including timely response to local events, products, or campaigns. This makes evalii® ideal for global pharmaceutical companies with decentralized teams.

  • How does evalii® work technically?

    evalii® uses a complex middleware architecture to connect and monitor a wide variety of digital channels. Proprietary, validated algorithms automatically analyze content for PV relevance, legal risks, and moderation requirements – reliably, scalably, and audit-compliant.

  • What is social media monitoring and listening with evalii®?

    Monitoring: evalii® actively monitors your channels (e.g., Facebook, Instagram, Twitter/X, WhatsApp Business API, app stores, HCP portals) for direct posts, comments, ads, and other posts. Listening: evalii® also detects indirect mentions in public sources—including blogs, forums, patient portals, and RSS feeds—for sentiment analysis and early detection.

  • Which content and platforms can be monitored?

    evalii® scans, among other things: Social Media: Facebook, Instagram, Twitter/X, TikTok, YouTube, Snapchat, LinkedIn, etc. Review and communication channels: WhatsApp, app stores (including Apple App Store, Google Play Store), Google Maps, Amazon, emails, YouTube, and website forms Communities & specialist portals: HCP forums, patient portals, blogs, Reddit, RSS

  • How does the response to detected content occur?

    - Automatic classification, - Escalation according to defined workflows, - Escalation of PV-relevant content within 6 hours, 12 hours or 24 hours, - Moderation according to netiquette

  • How does evalii® support pharmacovigilance?

    evalii® detects, documents, and reports PV-relevant content according to internal and regulatory deadlines. The solution relieves the burden on internal PV teams and enables monitoring of even large amounts of data.

  • How does community management work with evalii®?

    Upon request, evalii® will moderate your channels. This includes responding to comments, adhering to netiquette, reviewing legally sensitive content, and automatically initiating escalation.

  • Can evalii® also be operated by internal teams?

    No. evalii® is a fully managed service and is operated exclusively by the experienced team at Cross4Channel GmbH. This ensures consistently high quality, audit compliance, and regulatory security – without any additional burden on your internal resources.

  • Is evalii® suitable for large campaigns?

    Yes. evalii® is scalable, stable, and designed for high-volume projects—including international market launches.

  • Is evalii® audit compliant?

    Yes. evalii® has been successfully audited several times in recent years by international pharmaceutical customers and as part of ISO 9001:2015 audits.

  • Which regulatory requirements are met?

    evalii® comprehensively meets the regulatory requirements for use in national, European, and international pharmacovigilance systems. This includes, among others, EU regulations such as Regulation (EC) No. 726/2004, Directive 2001/83/EC, and Implementing Regulation (EU) No. 520/2012. Good Pharmacovigilance Practices (GVP) also apply, as do the German Medicines Act (AMG) and FDA regulations (21 CFR Part 314 & Part 600). International standards such as the ICH Guidelines (e.g., ICH E2E, E2D) have also been considered, ensuring compatibility with international pharmacovigilance guidelines. Data protection requirements according to the GDPR and international information security standards are also implemented.

  • What certifications does evalii® have?

    - ISO 9001:15 (Cross4Channel GmbH), - ISO 27001 (data centers), - Technical and organizational - - measures for data protection security are fully documented.

  • How is data processed?

    The data is processed exclusively in German, ISO-certified data centers. Storage is encrypted, role-based, and complies with GxP guidelines.

  • How does evalii® ensure the protection of personal data?

    evalii® is committed to comprehensive compliance with the General Data Protection Regulation (GDPR) and relevant international data protection regulations. The protection of personal data is ensured by a multi-level data protection and IT security concept that includes comprehensive technical and organizational measures (TOM), such as the pseudonymization of personal data, data backup, and access restrictions.

  • Is a data processing agreement (DPA) offered?

    Yes. evalii® provides a data processing agreement (DPA) in accordance with Art. 28 (3) GDPR that meets all legal requirements.

en_USEnglish
de_DEGerman en_USEnglish