Hybrid Delivery Model
Hybrid Delivery Model
Delivery Model
Built for Blended Delivery Needs
Not every sponsor fits into a single outsourcing structure. Some studies need broad end-to-end support, while others require targeted functional expertise, embedded execution capacity, or technology-enabled services alongside sponsor-led oversight.
IQA’s Hybrid Delivery Model is built for that reality. We combine full-service execution, functional outsourcing, embedded teams, and specialized support in a structure tailored to each study, function, and program. The result is a more flexible model that helps sponsors balance control, scalability, and execution efficiency without compromising visibility or quality.
Delivery Structure
What This Hybrid Model Delivers
Fit-for-Purpose Delivery
- Use the right combination of delivery models based on study scope, internal capability, timelines, and execution needs.
Greater Flexibility
- Blend full-service delivery, functional outsourcing, embedded teams, and specialist support instead of forcing one model across every study.
Smarter Use of Internal Teams
- Keep strategic oversight and selected functions in-house while extending execution capacity where it adds the most value.
Scalable Support
- Expand or reduce support across functions, studies, and programs as priorities evolve.
Cross-Functional Continuity
- Maintain aligned delivery across operations, biometrics, writing, safety, regulatory, and technology workstreams.
Operational Efficiency
- Structure support in a way that improves responsiveness, coordination, and cost efficiency across the portfolio.
Structure Options
How the Hybrid Model Can Be Structured
Full-Service Core with Functional Carve-Outs
Use a broader full-service model while retaining selected strategic or specialist functions internally.
FSP with Embedded Team Support
Combine dedicated functional support with embedded teams that work within your systems, workflows, and governance structure.
FSO with Biometrics or Specialist Carve-Outs
Use integrated study delivery while engaging focused support across biometrics, medical writing, safety, regulatory, or technology-enabled functions.
Sponsor-Led Model with Targeted Outsourcing
Retain internal program leadership while outsourcing selected functions, workstreams, or study activities.
Multi-Study Flexible Mix
Apply different delivery models across studies, phases, functions, or regions based on program needs.
Best Fit
When This Hybrid Model Is the Right Fit
When one model does not fit every study
Different studies often need different levels of oversight, execution support, and specialization.
When sponsors want to retain control in selected areas
Sponsors may want to keep strategy, governance, or certain functions in-house while outsourcing others.
When support needs change over time
Requirements may shift across startup, conduct, closeout, submission, or portfolio expansion.
When specialized expertise is needed
Hybrid models work well when targeted support is needed across biometrics, data, safety, writing, regulatory, or technology functions.
When flexibility and continuity are both important
Sponsors can scale support without losing delivery stability or team alignment.
Capabilities
Functions and Capabilities We Support
Clinical Operations
Study coordination, startup support, trial tracking, monitoring support, and operational oversight.
Clinical Data Management
Database build support, data cleaning, reconciliation, coding coordination, and database lock readiness.
Biostatistics
Statistical planning, SAP support, randomization input, analysis review, and regulatory-facing statistical support.
Statistical Programming
SDTM, ADaM, TLFs, define.xml, automation support, and submission-ready programming deliverables.
Medical Writing
Protocols, study reports, regulatory documents, and other medical writing deliverables across the study lifecycle.
Medical Coding
MedDRA and WHO Drug coding support through governed, quality-driven workflows.
Pharmacovigilance Support
Safety workflow support, reconciliation, coding coordination, and operational support for safety activities.
Regulatory Support
Standards alignment, submission support, and readiness across downstream regulatory workflows.
Technology and Managed Support
Veeva support, cloud operations, DevOps coordination, application support, integrations, and regulated IT support where required.
How It Works
How We Build the Right Hybrid Delivery Model
Assess Your Operating Structure
We evaluate what should remain internal, what should be outsourced, and where flexibility is most needed.
Define the Delivery Mix
We design the right balance of full-service support, functional outsourcing, embedded teams, and specialist services.
Align Teams and Governance
We establish roles, reporting structures, communication cadence, and oversight pathways across all delivery components.
Launch with Clear Accountability
Each function and workstream is aligned to defined ownership, timelines, and delivery expectations.
Adapt as Programs Evolve
The model can be adjusted as studies progress, priorities shift, or portfolio needs expand.
Governance
Governance and Oversight Across the Hybrid Model
Clear Role Definition
Responsibilities are defined across sponsor teams, functional teams, embedded teams, and outsourced workstreams.
Integrated Reporting
Delivery visibility is supported through structured updates, milestone tracking, issue management, and cross-functional reporting.
Aligned Communication
Operate through a governance structure designed around sponsor preferences and study needs.
Escalation Pathways
Ensure timely issue resolution through defined decision-making and escalation routes.
Performance Visibility
Track timelines, quality, service expectations, and function-level delivery across the hybrid model.
Why IQA
Why Sponsors Choose IQA
Frequently Asked Questions
Build the Right Delivery Model for Your Studies
Combine full-service execution, functional expertise, embedded teams, and specialist support in a model designed around your internal structure, study needs, and growth plans.