Celero

Transforming Clinical Research

Celero logo featured in a case study about clinical research operations, showcasing AI, compliance, and efficiency improvements led by Adeeb Khan.
Healthcare professional administering a vaccination to a patient, symbolising patient-centric innovation in clinical research led by Adeeb Khan at Celero.
Vice President of Product

Directed the product, data, and technology portfolio for a startup Clinical Research Organisation (CRO), achieving a 673% increase in operational efficiency and unlocking $150M in patience-centric value for Clinical Trials.

Life Sciences

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.

Despite the market’s growth trajectory, CROs face a series of pressing challenges:

Rising Complexity of Clinical Trials
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 & Data Integrity
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 Access with 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.

Response

In response to these challenges, Celero, a challenger CRO led by a visionary CEO, set forth a mission to differentiate itself through a model focused on innovation, efficiency, and global accessibility. With a commitment to leveraging advanced technology and AI, Celero sought to establish itself as a frontrunner in the next generation of clinical trials. The CEO engaged Adeeb Khan, who has a proven record in transformative portfolio management, to create a competency from inception to support future growth.

Transformation & Value Creation

To address these challenges, a phased, multi-year strategic roadmap was developed, focusing on maturing the organisation iteratively across global Compliance, Quality Management, and Agility.

Integrated Digital Ecosystem
Achieved a 673% increase in operational effectiveness through the design and deployment of a unified digital ecosystem. This interconnected architecture of 25 systems, including eQMS, CTMS, eTMS, EDC, ITSM, KMS, LMS, and CRM, streamlined clinical research, quality, regulatory, and operational functions.
Compliance Innovation
Developed an integrated compliance framework that combined Lean Canvas, SAFe, Gherkin Scenarios, and ISO standards with regulatory requirements (21 CFR Part 11, EU Annex 11, HIPAA, ISO 27001, GDPR). This framework created $5M in compliance value by ensuring robust traceability, high availability, and audit readiness. Successfully passing 13 independent audits, including one by the Bill & Melinda Gates Foundation, established a resilient and future-proof competency.
Cost Transformation & Patient Accessibility
Reduced project costs by 80% and accelerated rollout times by 50% through world-class execution across product management, data, user experience, technology, and AI. The savings were reinvested into patient-focused initiatives, generating $150M in patient-centric value.
Data & AI-Enabled Operations
Implemented a phased AI adoption strategy, overhauling data architecture and prioritising key department deployments to enhance decision-making and operational outputs. The integration of AI progressively into core processes culminated in automated workflows, reducing manual intervention by 40%. Laying the foundation for sustained efficiency, equipping the CRO to respond dynamically to client needs and regulatory demands.
Security & Resilience
Introduced a zero-trust security model, incorporating Microsoft SSO, multi-factor authentication (MFA), conditional access, and role-based access control (RBAC). The infrastructure reduced security risks by 35%, embedding continuity protocols to protect data integrity and ensure compliance, addressing the critical importance of data protection in clinical research, where breaches can cost up to $4 million.
Product Operating Model
Established a product-centric operating model based on the Lean Canvas, OKRs, Jobs to Be Done, Customer Journey Mapping, Data Mapping and Value Proposition Canvas frameworks, reducing time-to-market by 30% and accelerating feature releases by 25%. Enabling the CRO to meet evolving industry and regulatory demands with agility.
Brand Design System
Deployed a brand and product component library to ensure consistency and agility across platforms, accelerating product development by 40% and ensured brand cohesion, enhancing market responsiveness and trust across all touchpoints.

Conclusion

This engagement provided Celero with a strategic and scalable foundation, enabling the organisation to meet complex regulatory demands, drive operational excellence, and deliver transformative, patient-centric value in clinical trials. By harnessing innovative technologies and robust compliance frameworks, Celero is positioned to lead in the rapidly evolving CRO landscape, setting new standards in efficiency, regulatory alignment, and client trust.

Skills & Expertise

Strategic, leadership and technical competencies applied to this engagement.

  • Compliance & Quality Management
    • 21 CFR Part 11
    • Audit & Inspections
    • Computer Sytem Validation (CSV)
    • EU Annex 11
    • GAMP 5
    • General Data Protection Regulation (GDPR)
    • ISO 27001
    • ISO 9001
    • Risk Assessment
    • Risk-Based Approach
    • Standard Operating Procedures (SOPs)
  • Cybersecurity
    • Conditional Access
    • Data Encryption
    • Data Security & Privacy
    • Identity & Access Management (IAM)
    • Multi Factor Authentication (MFA)
    • Permission Groups
    • Role-Based Access Control (RBAC)
    • Security Audits
    • Single Sign On (SSO)
    • Threat Detection & Response
    • Zero Trust
  • Data & Insights
    • Business Intelligence (BI)
    • Data Analytics & Insights
    • Data Architecture
    • Data Lifecycle Management
    • Data Modelling
  • Experience Design
    • Brand Development
    • Design Systems
  • Operations & Process Optimisation
    • Agile Methodologies
    • Continuous Improvement
    • Department Management
    • Digital & Collaboration Tools
    • Hiring & Interviewing
    • Kanban
    • Lean
    • Operating Models
    • Workflow Automation
  • Sales & Marketing
    • Digital Marketing (SEO, Social Media, Email, PPC)
    • Pipeline Management
    • Sales Strategy & Planning
  • Strategy & Product Management
    • Competitive Analysis
    • Digital Transformation
    • Innovation
    • Lean Canvas
    • OKRs & KPIs
    • Performance Measurement & Analytics
    • Portfolio Management
    • Portfolio Strategy
    • Problem Statement
    • Product Feature/Enabler Tree
    • Product Lifecycle Management
    • Product Strategy
    • Release Planning
    • Risk Management & Mitigation
    • Strategic Planning
    • Strategic Roadmap
    • Strategic Themes
    • Vendor Management
    • Vendor Selection
    • Version Roadmap
  • Technology
    • Automation & Artificial intelligence (AI)
    • Business Continuity & Disaster Recovery
    • Cloud Infrastructure & Platforms
    • Help Desk & ITSM
    • Responsive & Adaptive Design
    • Systems Integration
    • Technical Architecture & System Design
Platforms & Systems

Responsible platforms, systems, products, and technologies.

  • Clinical Trial Management System (CTMS)
  • Customer Relationship Management (CRM)
  • Electronic Data Capture (EDC)
  • Electronic Quality Management System (eQMS)
  • Electronic Trial Master File (eTMF)
  • Knowledge Management System (KMS)
  • Learning Management System (LMS)
  • LinkedIn Recruiter
  • LinkedIn Sales Navigator
  • Microsoft 365
  • Microsoft Bookings
  • Microsoft Entra
  • Microsoft Excel
  • Microsoft Forms
  • Microsoft Lists
  • Microsoft Power Automate
  • Microsoft PowerBI
  • Microsoft PowerPoint
  • Microsoft SharePoint
  • Microsoft Teams
  • Microsoft Word
  • Miro
  • Salesforce
  • Websites & Content Management Systems