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  •  21 CFR part 11 compliant solutions

  • Analytics

  • Audit trails

  • BPO - Business Process Outsourcing

  • Cloud-based offerings - Single/multi/network tenant technologies

  • Consultancy

  • Data repositories

  • EDI - Electronic Data Interchange

  • Enterprise workflow management

  • Governance

  • GxP based implementation experience

  • Highly configurable solutions

  • Integration of mobile solutions and apps with multiple enterprise systems

  • Localisation (local language support for User Interfaces)

  • Master data and reference data connectivity and management

  • Off-the-shelf and custom solutions

  • Outsourcing

  • Partnering

  • Process automation

  • Project management

  • Real-time data analytics

  • Regulatory compliance

  • Reporting integration

  • Risk management

  • Secure workflows

  • Security

  • Services

  • SaaS (Software-as-a-Service)

  • Strategic alliances

  • Support

  • Track and trace (traceability)

  • Training

Standard
Clinical trials

Clinical Trials

  • Adverse event reporting infrastructure

  • Audits

  • Autologous study support

  • Automated finance management

  • Clinical study budgeting (site and patient finances)

  • Clinical study forecasting  for sites and patient finances

  • CTMS - Clinical Trial Management System

  • Connected data across the enterprise, partners, sites, and end users/subjects

  • D2P - Direct-to-Patient

  • DCT - Decentralised trials

  • Diversity

  • Dosing management

  • Drug supply forecasting

  • eClinical

  • eCOA - Electronic Clinical Outcome Assessment

  • eConsent

  • EDC - Electronic Data Capture systems

  • Environmental sustainability

  • ePRO - Electronic Patient-Reported Outcome

  • Interoperability

  • Investigator meetings

  • IoT - Internet of Things

  • IRT - Interactive Response Technology

  • IVRS - Interactive Voice Response System

  • IWRS - Interactive Web Response System

  • Localised language telephone support

  • MDM - Master Data Management and analytics

  • Patient advocacy

  • Patient compliance solutions

  • Patient recruitment

  • Patient reimbursements

  • Patient retention

  • QP services - Qualified Person services

  • Randomisation in clinical trials

  • RWE - Real World Evidence

  • RTSM - Randomisation and Trial Supply Management

  • Site payment solutions

  • Site payments

  • Subject-blinded reporting from sites

  • Veterinary product management

  • Wearable devices

Clincal
Supply
Pharma serialization track and trace

Supply Chain,
Serialisation, and Traceability

  • AI/Machine Learning in supply chain planning

  • Audits

  • Connected data across the enterprise and partners

  • D2P - Direct-to-Patient

  • Drug supply forecasting

  • DSCSA - Drug Supply Chain Security Act

  • EPCIS - Electronic Product Code Information Services

  • EU FMD - The EU Falsified Medicines Directive

  • Interoperability

  • QP services - Qualified Person services

  • Traceability

  • VRS - Verification Router Services

  • Serialisation levels 1, 2, 3, 4 and 5​

    • Level 1 - Device level - Barcode printers, label printers, and labellers for units of sale/packaging. Also includes cameras and scanners for quality control

    • Level 2 - Case or packaging line automation and control for data aggregation across Level 1 devices

    • Level 3 - Site-level systems that facilitate communication between Level 2 systems within a site, and connect to level 4. These systems manage and coordinate master data, serialisation of products, product, and work order information

    • Level 4 - Enterprise systems for business processes, global compliance, inter/intra-organisational connectivity, reporting, identity access management, application programming interfaces, and other enterprise-level functional areas.

    • Level 5 – Network. A network of supply chain partners, shared event repository, regulatory authorities such as national hubs, or international repositories such as the EMVS (European Medicines Verification System) in Europe, and ANVISA (the Brazilian Health Regulatory Agency) and the SNCM - Sistema Nacional de Controle de Medicamentos. Facilitates management of all serialisation and regulatory data with partners, customers, and authorities

ENTERPRISE ARTWORK, APPROVALS, WORKFLOWS, LABELLING AND DEVICE MANAGEMENT

Enterprise Artwork, Approvals, Workflows, and Labelling

  • Approvals workflow management

  • Audits

  • Automation of devices

  • Connected data across the enterprise, partners, and sites

  • Device-as-a-Service

  • Data verification

  • Document and content management

  • Enterprise artwork management

  • Enterprise labelling

  • EPCIS requirements - Electronic Product Code Information Services

  • EU FMD labelling - The EU Falsified Medicines Directive

  • EU MDR - EU Medical Device Regulation)

  • MDM - Master Data Management

  • Output management 

  • Printer management

  • Project management

  • Quality management

  • Qualified Person services

  • Randomisation in clinical trials

  • Serialisation labelling requirements

  • Subject-blinded reporting from sites

  • Vision systems (label quality management)

Artwork
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