In-Depth Reference

Guide to Clinical Trials for Ambulatory Infusion Centers

Published: 2025-12-11
Andrew Crimer
Director of Growth Marketing

Clinical research isn’t on most AICs’ roadmaps, but it seems to be on a lot of AIC operators’ minds. While researching this guide, we learned that operators across the ambulatory infusion center space are curious about conducting clinical trials, but are generally daunted by the required upfront investment, the adjusted expectations of their clinical staff, and the learning curves of finding and negotiating participation in revenue-positive trials.

Tennr does not offer clinical-research-related products, and we can’t help ease the pain of the upfront investment—but we can demystify the process and help operators think rationally about the ways research participation can be additive to their businesses. To help make that call, and to find ways to get started, we compiled this guide covering the opportunity and the requirements AICs need to fulfill to take advantage of it.

Disclaimer: This guide is provided for educational and informational purposes only and does not constitute legal, regulatory, business, or professional advice of any kind. The information contained herein is based on our understanding as of the publication date and may not reflect the most current legal or regulatory developments.

We make no representations or warranties regarding the accuracy, completeness, or reliability of this information. You should not rely on this guide as a substitute for professional advice tailored to your specific circumstances. Business decisions based on this guide are made at your own risk, and we disclaim all liability for any damages, losses, or adverse outcomes resulting from your use of or reliance on this information.

We strongly recommend consulting with qualified legal, regulatory, and business professionals before making any decisions that could affect your operations, compliance, or business strategy.

Table of Contents

Chapters

01
chapter 1

What is clinical research?

An overview of the process of clinical trials for drug development.

1.1
Drug development overview

How a manufacturer brings a new drug to market.

1.2
Four phases of human trials in clinical research

The four phases of human trials, and the questions about the investigational drug each phase answers.

1.3
Standards and regulations

Who oversees clinical trial conduct in the United States?

1.4
Why independent medical providers participate in clinical trials

Behind the move away from research-institution-centric trials.

1.5
Benefits of participating for AICs

Revenue, efficiency, and access.

02
Chapter 2

Roles and relationships in clinical trials

Discussing all the participants in the process of clinical research, including sponsors, CROs, sites, researchers, and site networks.

2.1
Participants overview

Understanding the relationship between sponsors and sites (with a helpful diagram).

2.2
SMOs, site networks, and PAOs

The current state of site-side coordination, including Patient Access Organizations.

03
Chapter 3

Minimum requirements to participate in clinical trials as a research site

The upfront investments, personnel, and facilities capacity AICs need to become trial sites.

3.1
Requirements breakdown
3.2
Personnel

A qualified, licensed researcher and trial-focused staff

3.3
Organizational and physical capacity

Storage, training, SOPs, and data practices that trials require.

3.4
Independent site appeal for CROs

Sponsors and CROs prefer sites that distinguish themselves in three key ways:

3.5
AIC advantages in patient recruitment

How AICs' existing patient populations give them an edge in recruiting diverse volunteers.

04
Chapter 4

How to solicit and secure profitable clinical trials

Where AICs can find drug studies and sponsors that make sense for their site (including pharma databases).

4.1
Identifying trials that make sense

Comparing a site's strengths to a trial's protocol and budget.

4.2
Where to find pharma-sponsored clinical trials

Pharma databases, websites, and site intermediaries where sites can find trials.

05
Chapter 5

Study start-up process for clinical trials

The journey from a site's first contact with the sponsor to patient enrollment.

5.1
Start-up process steps
5.2
Site feasibility and site selection

Evaluating the mutual fit between a site and a trial.

5.3
Clinical trial agreements and recruitment expectations

The contracts governing trials and the strategy for finding study volunteers.

06
Chapter 6

Negotiating clinical trial agreements and budgets

Fee structures, common contract language adjustments, and margin considerations.

6.1
Language, recruitment, monitoring, and payment terms

What sites should know before entering clinical trial agreement negotiations.

6.2
Budget negotiation topics and fee structures

How do AICs know if they can make money on any given trial?

6.3
Signing CTAs and site initiation

What happens after the CTA is signed?

07
Chapter 7

Clinical trial recruitment best practices and hurdles

Taking a look at the reality of finding patients to volunteer for trials.

7.1
How research sites recruit volunteers

Researchers find trial volunteers through referrals and advertising.

7.2
AIC marketing and advertising advantages

Marketing tactics that can work well for clinical research.

08
Appendix

Further reading and resources

8.1
Included resources
8.2
Regulatory, compliance, and legal resources
8.3
Good Clinical Practice resources
8.4
Market research: site networks and PAOs
8.5
IRBs and IRB services
8.6
Pharma-operated site databases
8.7
Site networks and placement services
8.8
Clinical research associations & organizations
8.9
Events for clinical researchers with drug development focuses
8.10
Clinical trial conduct training providers
8.11
Clinical trial agreement resources:
8.12
Clinical trial budget resources