Project-Based Embedded Teams for Small and Emerging Sponsors
Delivery Model
Built for Lean Sponsor Teams
Small and emerging sponsors often do not need large full-time internal teams across every clinical function. What they need is a practical way to retain strategic oversight while accessing experienced delivery support throughout the study lifecycle.
Our Project-Based Embedded Team model is designed for that need. Your internal leaders remain in control of strategy, governance, and key decisions, while our team works within your systems, workflows, and operating environment to support execution across your studies. The model is structured around project-based pricing, giving you study-long access to embedded support without the hourly billing structure of traditional FSP arrangements.
Delivery Structure
What This Embedded Team Model Delivers
Lean Internal Operating Model
- Keep your core team focused on oversight, sponsor decisions, and study leadership while extending delivery capacity through embedded support.
Study-Long Team Availability
- Access support throughout the study lifecycle, with a team that remains aligned to your environment and ready to engage when needed.
Project-Based Commercial Structure
- Benefit from a study-aligned pricing model that supports commercial predictability, rather than hourly billing tied to resource utilization.
Embedded Sponsor Alignment
- Our team works within your systems, workflows, governance structure, and communication model for smoother collaboration.
Flexible Functional Coverage
- Access support across one function or multiple functions based on study scope, internal capability, and delivery needs.
Scalable Support
- Add one specialist or broader team support depending on the size, complexity, and stage of your study.
Functions and Capabilities We Support
Clinical Operations Support
Study coordination, tracking, startup support, and operational oversight activities.
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 Support
Protocols, study reports, regulatory documents, and other medical writing deliverables across the study lifecycle.
Medical Coding
MedDRA and WHO Drug coding support through structured, 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.
How the Embedded Team Model Works
Understand Your Study Needs
We assess your study scope, internal team structure, functional gaps, and support requirements.
Define the Right Team Model
We align the right mix of roles, functions, and delivery support to fit your study or program needs.
Embed into Your Environment
Our team works within your systems, workflows, governance framework, and communication structure.
Support Delivery Throughout the Study
The team remains available across the study lifecycle, providing support as needed based on workload, milestones, and evolving delivery requirements.
Operate Through a Project-Based Structure
Rather than billing by the hour, the model is aligned to project or study support, helping improve commercial clarity and predictability.
How This Model Differs from Traditional FSP
Traditional FSP
Often structured around hourly, utilization-based, or FTE-linked commercial models for dedicated functional support.
Project-Based Embedded Team Model
Provides embedded support throughout the study lifecycle, with a project-based commercial structure designed around study execution rather than hourly billing.
What This Means for Sponsors
Maintain access to aligned functional expertise and delivery continuity, while benefiting from a more practical model for lean sponsor organizations.
When This Model Is the Right Fit
For Small and Emerging Sponsors
When internal teams want to remain lean while accessing experienced study delivery support.
For Sponsor-Led Programs
When sponsors want to retain control of strategy, governance, and decision-making while extending execution capacity.
For Studies Needing Continuity Without Overbuilding
When the study requires ongoing support, but the sponsor does not want to build large permanent internal teams.
For Organizations Seeking Predictable Commercial Structures
When project-based pricing is a better fit than hourly or utilization-driven billing.
For Growing Portfolios
When support needs may expand across functions or studies over time.
Why IQA
Why Small and Emerging Sponsors Choose IQA
Governance
Governance and Oversight
Sponsor-Controlled Decision-Making
Your internal team retains oversight, governance, and key study decisions.
Defined Roles and Accountability
Clear responsibilities and reporting structures support aligned execution across sponsor and delivery teams.
Structured Communication
Teams work within your preferred meeting cadence, governance model, and communication pathways.
Performance Visibility
Delivery is supported through regular updates, issue tracking, and aligned expectations.
Embedded Collaboration
Because the team works within your environment, coordination is more connected and responsive across study activities.
Frequently Asked Questions
Build a Smarter Delivery Model for Your Study
Keep your internal team focused on strategy and oversight while extending study delivery through embedded, project-based support designed for small and emerging sponsors.