Celero
Transforming Clinical Research
Executive Summary
Led product strategy and AI transformation for a startup Clinical Research Organisation (CRO) serving 250,000+ patients globally, achieving 673% operational efficiency gains and creating $25M in patient-centric value through an AI-first product operating model.
The Challenge
The global CRO market, currently valued at $82 billion and projected to reach $129.8 billion by 2029 with a compound annual growth rate (CAGR) of 9.6%, is experiencing robust growth. This expansion is driven by the increasing demand for outsourced research, as pharmaceutical and biotech companies face pressures to develop treatments more efficiently and economically. With the growing complexity of drug development spanning advanced therapies, gene editing, and personalised medicine, companies are finding it essential to leverage external expertise and infrastructure to manage clinical trials.
Outsourcing to CROs enables biopharma companies to reduce costs, minimise operational risks, and access the specialised knowledge required for today’s intricate trials. Furthermore, the shift toward globalisation in clinical trials, particularly the expansion into emerging markets, allows CROs to provide access to diverse patient populations and cost-effective trial locations. Regulatory pressures, heightened by the need for stringent data integrity and patient safety, have also made compliance a significant burden. CROs are positioned to navigate this regulatory landscape effectively, further reinforcing their value.
Rising Complexity
As therapeutic approaches evolve, the demand for sophisticated trial management has grown.
Trials now require meticulous data handling, multi-regional coordination, and an increased focus on patient-centric outcomes, all of which demand advanced technology and process integration.
Regulatory Compliance
With increasingly stringent regulatory standards, maintaining compliance has become a core focus. CROs must uphold robust frameworks such as 21 CFR Part 11, EU Annex 11, and ISO 27001 to meet global compliance expectations, all while maintaining efficiency and speed.
Cost Constraints
Given the high cost of drug development averaging $19 million per clinical trial, there is constant pressure to keep expenses manageable. CROs must deliver efficient services while balancing quality, speed, and cost-effectiveness for their clients.
Global / Local Impact
While globalisation enables access to diverse patient groups and cost-effective markets, CROs are also expected to make a positive local impact in these regions, which adds complexity in terms of pricing models, regulatory adaptations, and operational execution.
Platform Strategy & Orchestration
I joined Celero as Product Director as one of four founding team members when the organisation possessed no operational capabilities. I was accountable for building and leading the product organisation spanning data, user experience, technology, and cybersecurity to support organisational systems and clinical research trials serving 250,000+ patients globally whilst meeting the rigorous compliance requirements of the pharmaceutical industry.
Operating with constrained resources, I adopted an AI-first, iterative technology strategy to accelerate capability deployment without compromising quality. I architected the complete platform ecosystem and orchestrated the strategic deployment of each feature, product, and system, establishing a 25-product ecosystem within a secure, validated technology architecture that satisfied FDA, HIPAA, GDPR, ISO 9001/27001, and GAMP 5 requirements.
I built and led cross-functional teams across Product, Data, UX, and Engineering spanning five global regions whilst delivering quarterly board- level strategy presentations to maintain C-suite alignment. As the organisation scaled from 5 to 55 employees across global operations, platforms maintained 99.9% availability, demonstrating the resilience of the foundational architecture and operational frameworks established during the critical formation phase.
Product Ecosystem
Architected and deployed a unified digital ecosystem of 25 interconnected systems spanning clinical research, quality management, regulatory compliance, and operational functions. The architecture integrated specialist platforms including eQMS, CTMS, eTMF, EDC, ITSM, KMS, LMS, and CRM into a cohesive operational environment.
The ecosystem maintained 99.9% availability as the organisation scaled from 5 to 55 employees across five global regions, demonstrating the resilience of foundational architecture decisions.
Product Operating Model
Established a product-centric operating model combining Lean Canvas, OKRs, Jobs to Be Done, Customer Journey Mapping, and Value Proposition Canvas to evaluate strategic fit, operational feasibility, and patient-centric value across the portfolio. Developed interconnected strategic roadmaps that aligned product development with clinical research needs and regulatory requirements.
This framework enabled consistent prioritisation decisions and accelerated delivery, achieving 30% faster time-to-market and 25% feature release acceleration whilst maintaining rigorous compliance standards throughout the product lifecycle.
AI Transformation
Through systematic analysis of operational workflows, I identified a $25M transformation opportunity and secured $10M+ in executive investment by building a comprehensive business case. I validated 15+ AI use cases within the regulated environment and established an AI-first operating model that achieved 673% operational efficiency gains whilst reducing resourcing by 40%.
This transformed product development economics, delivering 80% cost reduction and 30% cycle time improvement through intelligent automation and platform orchestration, creating $25M in patient-centric value.
Compliance Framework
Developed an integrated compliance framework synthesising FDA, HIPAA, GDPR, ISO 9001/27001, GAMP 5, 21 CFR Part 11, and EU Annex 11 requirements into cohesive validation protocols embedded throughout the product lifecycle.
This created $5M in compliance value through robust traceability and audit readiness, successfully passing 13 major external audits including rigorous examination by the Bill & Melinda Gates Foundation, establishing resilient compliance competency.
Data & Security
Architected and centralised the complete data estate, establishing security and cybersecurity practices across global operations. Introduced a zero-trust security model incorporating Microsoft SSO, multi-factor authentication, conditional access, and role-based access control.
This significantly reduced security risks and supported AI adoption through consistent data models and governance frameworks. The centralised architecture transformed fragmented silos into a unified data estate powering analytics and automation.
Capabilities
Expertise
- Auditing
- Compliance Audits
- Quality Audits
- Security Audits
- Compliance
- 21 CFR Part 11
- Computer System Validation (CSV)
- General Data Protection Regulation (GDPR)
- HIPAA
- ISO 27011
- ISO 9001
- Customer Service & Support
- Customer Relationship Management (CRM)
- Help Desk & ITSM
- Service Level Agreements (SLAs)
- Customer-Centric Innovation
- A/B Testing
- Brand Development & Management
- Customer Journey Mapping
- Design Systems
- Feedback Loops
- Interaction Design (IxD)
- Responsive & Adaptive Design
- Usability Testing
- User Research
- Cybersecurity
- Conditional Access
- Data Encryption
- Firewall Management
- Identity & Access Management (IAM)
- Incident & Response Planning
- Log Management
- Multi-Factor Authentication (MFA)
- Permissions & Role-Based Access Control (RBAC)
- Single Sign-On (SSO)
- Threat Detection & Response
- Zero Trust Architecture
- Data & Artificial Intelligence
- Business Intelligence (BI)
- Data Analytics & Insights
- Data Architecture & Engineering
- Data Governance & Quality Management
- Data Modelling
- Enterprise AI Strategy
- LLM Use Case Definition
- Finance
- Budget Planning & Management
- Cost Optimisation
- Profit & Loss (P&L) Management
- Marketing & Communications
- Content Marketing
- Digital Marketing (SEO, Social Media, Email, PPC)
- Market Research & Analysis
- Operating Models & Value Orchestration
- Agile Methodologies
- Business Process Mapping & Optimisation
- Continuous Improvement
- Cross-Functional Collaboration
- Department Management
- Operational Performance & Reporting
- Process Automation
- People & Culture
- Line Management & Leadership Development
- Talent Acquisition & Retention
- Team Development & Coaching
- Platform & Product Strategy
- Business Case Development
- Business Model & Lean Canvas
- Competitive & Market Analysis
- Executive/Board Stakeholder Management
- Feature & Enabler Trees
- Go-To-Market Strategy
- OKR & KPI Definition
- Portfolio Management
- Product Lifecycle Management
- Release Planning & Management
- Strategic Roadmaps
- Strategic Themes
- Value Proposition Design
- Value Streams
- Version Roadmap
- Product Development & Delivery
- Backlog Prioritisation
- Cross-Functional Team Leadership
- Definition of Done (DoD)
- Feature Prioritisation
- Product & Agile Team Development
- Sprint Planning & Delivery
- User Stories & Acceptance Criteria
- Quality Assurance
- Corrective & Preventive Actions (CAPA)
- Quality Assurance (QA)
- Risk-Based Quality Approach
- Technology & Infrastructure
- Automation
- Business Continuity & Disaster Recovery
- Cloud Strategy & Management
- Monitoring & Logging
- Network Infrastructure Management
- Technical Architecture & System Design
- Vendor Management & Selection
Technologies
- Backend & Cloud Infrastructure
- Microsoft Azure
- Collaboration & Productivity Tools
- Microsoft SharePoint
- Microsoft Teams
- Miro
- Data & Analytics
- Google Analytics
- Google Tag Manager
- Microsoft Power BI
- SEMRush
- DevOps & Site Reliability
- Docker
- GitHub
- Digital Experience Platforms & CMS
- WordPress
- Digital Marketing & Customer Engagement
- Mailchimp
- ERP & Supply Chain
- DocuSign
- Front-End Development
- CSS
- HTML
- JavaScript
- React
- TypeScript
- Health & Life Sciences
- Clinical Trial Management System (CTMS)
- Electronic Data Capture (EDC)
- Electronic Quality Management System (eQMS)
- Electronic Trial Master File (eTMF)
- Machine Learning & AI
- Anthropic
- Google Gemini
- Microsoft Copilot
- OpenAI
- Programming & Data Languages
- PHP
- Python
- Project & Product Management
- Atlassian Confluence
- Atlassian Jira
- Sales & CRM
- LinkedIn Sales Navigator
- Microsoft Bookings
- Salesforce Sales Cloud
- Security & Identity Management
- Microsoft Defender
- Microsoft Entra
- Microsoft InTune
- Microsoft Purview
- Strategy & Business Planning
- Microsoft Excel
- Microsoft Power BI
- Microsoft PowerPoint
- Microsoft Word
- Miro
Results & Outcome
The transformation delivered more than a product roadmap. It established Celero’s operational foundation from inception, creating a compliance-validated clinical research organisation serving 250,000+ patients globally. The organisation evolved from a four-person founding team to a scalable CRO capable of competing with established pharmaceutical service providers, achieving 673% operational efficiency gains whilst delivering $25M in patient-centric value.
Platform & Ecosystem
interconnected products architected from inception across clinical research, quality, regulatory, and operational functions.
platform availability maintained throughout organisational scaling and system expansion.
Operational Transformation
reduction in product development costs through intelligent automation and agile optimisation.
reduction in resourcing requirements whilst scaling from 5 to 55 employees across five global regions.
Compliance
major external audits passed, including rigorous examination by the Bill & Melinda Gates Foundation.