Jonas
Vasey
jonas.vasey@arcondis.com COO, Problem Solver
Services
Clients rely on us for our outstanding expertise in compliance, business processes, information technology, digital transformation and engagement.
Our focus
Rolling up our sleeves to make healthcare better: below we’ve picked a handful of success stories out of the more than 2,500 projects we’ve delivered for clients so far.
Putting pen to paper to explain healthcare better: Sometimes, we also share our knowledge or perspective on a salient topic with the world, in the form of insights or whitepapers.
Services
Here’s a more detailed list of all the services we have to offer.
Compliance Services
Single Use Technology (SUT)
Digital Compliance
Supply Chain Compliance
Laboratory & Quality Control
Manufacturing Compliance
Clinical Affairs
Compliance Project Management
Regulatory Affairs
Quality Management
Qualification
Validation
Single Use Technology (SUT)
Make the manufacturing process faster, more flexible, and more predictable. Reduce the risk of contamination and speed up change-overs in a regulated and compliant way.
Process optimization (manufacturing transfer) through SUT implementation:
Assess current state | Evaluate benefits of change | Assess and select best supplier candidate
Regulatory compliance for SU component design and integration, e.g., mechanical, physical, chemical, operational and shelf-life robustness requirements
Compliant upgrade of devices for SU applications, addressing plastic leachability, limited mechanical robustness, (bio-) chemical sustainability
Quality management system adaptation | Preparation for audit inspections | assistance in internal audit activities
Also look into our Business Services offering for Single Use Technology
Digital Compliance
Ensuring compliance and management of risks relating to digital solutions
Data Privacy (GDPR)
Compliance of new technologies, e.g. GxP in the cloud, Blockchain, AI, etc.
IT Security, e.g. ISO 27001
Record Management & Digital Signatures
Supply Chain Compliance
Ensuring compliant value chain
Track & Trace solutions
Compliance & Ethics
Transport validation to ensure full supply chain compliance
Laboratory & Quality Control
Ensuring compliance in lab environment
LIMS / ELN controlled implementation and support
Lean approaches in QC, e.g. six sigma
Technical writing support
Manufacturing Compliance
Ensuring compliance in production environment
Quality engineering to ensure & optimize product quality
Industry 4.0 / Manufacturing 4.0
Manufacturing Execution System (MES) & process automation
Validation of distributed control systems, e.g. SCADA
Clinical Affairs
Compliance expertise in clinical investigations and studies
eTMF to secure integrity of clinical data
Clinical data management and study design
Post Market Clinical Follow up studies support
Compliance Project Management
Doing the right thing right from the start
QMS (e.g. ISOs 13485, 9001…) Implementation, Management and/or as a Service
Project Quality Management
Leading from small sub projects up to programs, e.g. mergers & acquisitions
Regulatory Affairs
Ensuring compliance to (new) regulations
Projects with regulatory agencies
Compliant Market Access
Regulations experts, e.g. MDR & IVDR and new approaches
Software as Medical Device
Quality Management
Ensuring organizational, production and service consistency
Auditing services (3rd Party, Mock, preparation, …)
Non-Conformity Management, e.g. Deviations, CAPA etc.
And other quality processes, e.g. Complaint Management, Post Market Surveillance, etc.
Qualification
Agile, digital, standard, and qualification approaches for
Equipment & Instrument Qualification
Sterile Environment Qualification (Clean room…)
Facilities & Machinery Qualification
Validation
Agile, digital, standard and lean validation approaches for
Process & Transport Validation
Method & Cleaning Validation
CSV (Enterprise Resource Planning, Excel..) & Coordination & Support Actions
Validation as a Service
Business Services
Single Use Technology (SUT)
3D Printing
Data Governance
Data Science
Future Lab
Digital Factory
Business Process Management
Business Analysis
Organisational and Transformational Change
Business Continuity Management
Strategy Definition and Execution
Single Use Technology (SUT)
Make the manufacturing process faster, more flexible, and more predictable. Reduce the risk of contamination and speed up change-overs in a regulated and compliant way.
Process optimization (manufacturing transfer) through SUT implementation:
Assess current state | Evaluate benefits of change | Assess and select best supplier candidate
Planning | Execution | Success evaluation | Continuous control strategy definition (e.g., lean six-sigma)
Waste management strategy, addressing environmental aspects
Organisational change management and training
Also look into our Compliance Services offering for Single Use Technology
3D Printing
Introducing and integrating new technologies and equipment in organizations
Implementation of compliance and data management for novel instruments
3D printer qualification and validation
Selection of technology for 3D printing
Integration and training for 3D printing technology
Data Governance
Keeping data accessible, shareable and secure
Development of data standards and guidelines ensuring integrity throughout the data life cycle
Managing Master Data for optimal data quality
Governing infrastructure and processes towards security, scalability and suitability for current and future data needs
Data Science
Overcoming obstacles in data generation, useability and automation
Advanced analytics to develop algorithms, facilitating better decision making based on data
Development & deployment of Machine Learning and Artificial Intelligence solutions for more predictive power and automated forecasts
Future Lab
Digitalize and automate lab operations to speed up and improve the R&D process
Design & Implementation of smart and interconnected laboratories
Connection of data systems (ELN, LIMS, LES, …) for seamless data flow
Automation of hardware and software to make labs function more efficiently
Digital Factory
Industry 4.0 – Improving manufacturing through automation
Develop and deploy predictive process control strategies
Design continuous manufacturing processes
Help manufacturing sites design and deploy automated quality testing and reporting
Business Process Management
Lean processes and process understanding
Analysis and modification of business processes
Cost reduction and enhanced quality of process outputs
Standardisation of customer processes and workflows
Business Analysis
Understanding business needs and interfacing with technical groups for effective solutions
Requirement gathering process, business needs and documented user requirements
Communication facilitation for better understanding between business and technology groups
Analysis and optimisation of the user experience (UX) if proposed solutions
Organisational and Transformational Change
Implementing effective change across the organization
Support of organisation-wide changes and knowledge transfer
Create long-lasting improvements throughout the company
Guidance through cultural change
Organizational change management support to ensure buy in from key stakeholders
Business Continuity Management
Help organizations to maintain reliable, high-quality operations under challenging conditions
Providing technology support to continue business functions at all times
Holistic approach from initial analysis to continuous improvement
Strategy Definition and Execution
Providing strategic guidance to companies of all sizes
Enhanced clarity & directed action towards organisation goals
Alignment of projects and initiatives according to strategic objectives
Technology Services
Strategy & Governance
Service Orchestration & Management
Applications & Platforms
Cyber Security
M&A, Divestments and Partnering
Managed Projects & Services
Intelligent Automation
Internet of Everything
Democratisation of IT
Agile Culture
Strategy & Governance
Evolute to the next level
Strategic Innovation process
Target Operating Models
Digital & Organizational Assessment and Validation
Technology and Data Architecture and Interoperability
Service Orchestration & Management
Ensure seamless user experience
IT Service Management Implementation, Transition and Transformation
End-user Experience and Self-Services
Next Generation Workplace
Infrastructure Architecture and Management
Applications & Platforms
Conceptualisation, implementation and integration of new applications & platforms
Application Management and Rationalization
Hybrid-/multi-/distributed cloud strategy and implementation
Technology Evaluation for Blockchain based Solutions
Platform adoption and integration
Cyber Security
Protecting sensible data
Framework Assessment and Implementation
Management of IAM, Data, Application and Infrastructure Security
Threats Identification and Response
CISO, Testing or Training as a Service
M&A, Divestments and Partnering
Strategic advisory, tailored approaches and excecution management
Post Deal Integration and Separation
Value and Synergy Realization
Tender & Bidding Management for Partner Selection
Vendor & Operation Management
Managed Projects & Services
Client focused end-to-end delivery
Project Execution, Turnaround and Project Management as a Service
App Evaluation and Development
Application and Technology Operation and Maintenance
Innovative Technology Accelerator Services
Intelligent Automation
Boost efficency and user experience
Automation of Tasks, Processes and Operations (BPA)
Robotic Process Automation (RPA)
Artificial Intelligence (AI), Machine Learning (ML), e.g. Chatbots
Intelligent Document Processing and Computer Vision
Internet of Everything
Implementation of a fully connected environment
Physical and Cognitive Human Augmentation
Multi-experience Hardware, e.g. Wearables, Smart Devices, Sensors
Multi-experience Software, e.g. VR/AR, Autonomous Things, Robotics
Big Data Methods and Solutions
Democratisation of IT
People enabling
Citizens Devolper
Self-service Business Intelligence and Analytics
Evaluation and Operationalisation
Data-First Mindset and Education
Agile Culture
Value driven collaboration and people empowerment
Transformation to an Agile IT Organization
Agile Product development (SCRUM)
Agile Evaluation and Supplier Selection
Coaching (Bee AgileTM)
Engagement Services
Real World Evidence
Intelligent Platforms
Business Innovation
Online Marketing and Analytics
Portfolio and Product Augmentation
HCP Engagement
Patient Therapy and Monitoring
Real World Evidence
Micro- and Macro-Healthcare at your fingertips
Quality & credibility of data: Source and collection statistics
Functionality & Security of RWE (Real world evidence) platform
Standards & regulatory requirements for platforms
Intelligent Platforms
Leverage Machine Learning Technology
Education 4.0 platform
Patient-Watch
Product Safety Disclosures Process Automation
Business Innovation
Make Healthcare better
Implementation of Innovation Factory (Framework and Processes)
Facilitation of Design Thinking Workshops
Research & Technology Landscaping
Online Marketing and Analytics
Make informed decisions based on your audience
Online Marketing Concept and Metrics Framework
Implementation of Cross-Channel KPI metric platforms
Portfolio and Product Augmentation
Increase Adherence through modern technologies
Human-centric medical app design and development
Creation of Portfolio Digitalisation Roadmap
HCP Engagement
Delight HCPs by offering a state of the art omni-channel experience
Analysis of existing digital engagement channels and services
Creation of digital engagement strategy
Design and Implementation of mature & service oriented HCP offerings
Patient Therapy and Monitoring
Empower Patients and Support Clinical Decision Making
Improve patient outcomes and decrease healthcare costs
Development of digital solutions for long-term monitoring of patients’ health
Patient information platforms (e.g. trial recruiting)
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