Life Sciences Experience
One of our specialist areas is life sciences. We have more than seventeen years' business experience in solutions for the pharma and medical device sectors, including clinical trials.
One of our founders, Ray Collia, is an international speaker, round table and event chairperson, and patient and site evangelist in this sector. He was on the steering committee for the Pharmaceutical Contract Management Group between 2016 and 2023.
We moved into the life sciences sector for very specific reasons. To learn more, read Gina Collia's post, Why Do We Specialise in Writing for the Life Sciences Industry?
We have experience in over one hundred types of services and solutions that are used by pharma, biotechs, medical device companies, CROs, research sites, and patients.
The clinical trials landscape is complex.
We have over fourteen years' experience in Phase I - IV clinical trials solutions, so we understand what is important to stakeholders and patients
We have over twenty-seven years relevant experience in supply chain and traceability solutions, fourteen of which are directly within clinical trials and post-market pharma and medical device supply.
One of our founders is considered a subject matter expert in this area, having supported pharma and medical device companies for over sixteen years.
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21 CFR part 11 compliant solutions
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Analytics
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Audit trails
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BPO - Business Process Outsourcing
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Cloud-based offerings - Single/multi/network tenant technologies
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Consultancy
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Data management
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Data repositories
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EDI - Electronic Data Interchange
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Enterprise workflow management
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Governance
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GxP based implementation experience
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Highly configurable solutions
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Integration of mobile solutions and apps with multiple enterprise systems
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Localisation (local language support for User Interfaces)
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Master data and reference data connectivity and management
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Off-the-shelf and custom solutions
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Outsourcing
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Partnering
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Process automation
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Project management
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Real-time data analytics
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Regulatory compliance
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Reporting integration
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Risk management
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Secure workflows
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Security
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Services
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SaaS (Software-as-a-Service)
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Strategic alliances
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Support
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Track and trace (traceability)
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Training
Clinical Trials
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Adverse event reporting infrastructure
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Audits
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Autologous study support
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Automated finance management
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Clinical study budgeting (site and patient finances)
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Clinical study forecasting for sites and patient finances
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CTMS - Clinical Trial Management System
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Connected data across the enterprise, partners, sites, and end users/subjects
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D2P - Direct-to-Patient
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DCT - Decentralised trials
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Diversity
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Dosing management
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Drug supply forecasting
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eClinical
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eCOA - Electronic Clinical Outcome Assessment
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eConsent
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EDC - Electronic Data Capture systems
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Environmental sustainability
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ePRO - Electronic Patient-Reported Outcome
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Interoperability
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Investigator meetings
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IoT - Internet of Things
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IRT - Interactive Response Technology
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IVRS - Interactive Voice Response System
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IWRS - Interactive Web Response System
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Localised language telephone support
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MDM - Master Data Management and analytics
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Patient advocacy
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Patient compliance solutions
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Patient recruitment
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Patient reimbursements
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Patient retention
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QP services - Qualified Person services
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Randomisation in clinical trials
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RWE - Real World Evidence
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RTSM - Randomisation and Trial Supply Management
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Site payment solutions
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Site payments
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Subject-blinded reporting from sites
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Veterinary product management
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Wearable devices
Supply Chain,
Serialisation, and Traceability
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AI/Machine Learning in supply chain planning
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Audits
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Connected data across the enterprise and partners
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D2P - Direct-to-Patient
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Drug supply forecasting
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DSCSA - Drug Supply Chain Security Act
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EPCIS - Electronic Product Code Information Services
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EU FMD - The EU Falsified Medicines Directive
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Interoperability
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QP services - Qualified Person services
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Traceability
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VRS - Verification Router Services
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Serialisation levels 1, 2, 3, 4 and 5​
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Level 1 - Device level - Barcode printers, label printers, and labellers for units of sale/packaging. Also includes cameras and scanners for quality control
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Level 2 - Case or packaging line automation and control for data aggregation across Level 1 devices
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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
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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.
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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
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Enterprise Artwork, Approvals, Workflows, and Labelling
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Approvals workflow management
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Audits
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Automation of devices
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Connected data across the enterprise, partners, and sites
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Device-as-a-Service
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Data verification
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Document and content management
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Enterprise artwork management
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Enterprise labelling
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EPCIS requirements - Electronic Product Code Information Services
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EU FMD labelling - The EU Falsified Medicines Directive
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EU MDR - EU Medical Device Regulation)
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MDM - Master Data Management
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Output management
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Printer management
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Project management
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Quality management
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Qualified Person services
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Randomisation in clinical trials
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Serialisation labelling requirements
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Subject-blinded reporting from sites
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Vision systems (label quality management)