Site Selection and Infrastructure Needs for Early-Phase Trials

Table of Contents

Introduction

Early-phase clinical trials—especially Phase 1 studies—require specialized environments for participant safety, data integrity, and regulatory compliance. Choosing the right site is a critical success factor. From facility readiness to investigator experience, this tutorial explores how to select, prepare, and equip clinical sites for conducting high-quality early-phase trials.

Why Site Selection Matters in Phase 1 Trials

Unlike later-phase trials that focus on large patient cohorts and therapeutic outcomes, Phase 1 studies demand intense monitoring, tight protocol adherence, and robust bioanalytical support. Site infrastructure and experience play a pivotal role in minimizing risk, avoiding protocol deviations, and producing reliable pharmacokinetic and safety data.

Key Criteria for Selecting a Phase 1 Clinical Site

1. Prior Experience with Early-Phase Research

Has the site conducted first-in-human or SAD/MAD studies before?
Does the site understand the unique demands of exploratory and PK-driven protocols?
What is their track record with regulatory inspections and audits?

2. Qualified Investigators and Support Staff

Principal Investigator (PI) with experience in early-phase risk management and AE reporting
Sub-investigators with pharmacokinetic or imaging trial experience
Dedicated study coordinators and research nurses for 24/7 monitoring
In-house or affiliated pharmacologist, radiologist, and safety physician if required

3. Ethics Committee (EC/IRB) Accreditation

Site must be linked to a registered and experienced Ethics Committee
Preferably with experience reviewing FIH or high-risk studies

Core Infrastructure Requirements for Early-Phase Trials

1. Clinical Unit Facilities

Overnight stay and observation rooms for in-patient monitoring (especially for SAD/MAD studies)
Dedicated emergency crash cart and resuscitation equipment
Quiet, controlled environments for ECGs, vitals, and cognitive assessments

2. Laboratory and Sample Handling Infrastructure

On-site or rapid access to centrifuges, refrigerators (2–8°C), and ultra-low (-80°C) freezers
Sample tracking, labeling, and chain-of-custody SOPs
Validated bioanalytical lab partnership (on-site or courier-linked)

3. Drug Storage and Pharmacy Setup

Secure, access-controlled IMP (Investigational Medicinal Product) storage area
Temperature monitoring and calibration logs
Trained pharmacist or IMP custodian familiar with handling blinded/randomized studies

4. Safety and Emergency Capabilities

Emergency medical response team on standby or within rapid reach
Access to hospital ICU within 30 minutes
Protocols for unblinding and managing SAE in real time

Data Collection and Technology Readiness

Validated EDC systems with real-time data entry capabilities
Secure Wi-Fi and digital audit trail for remote monitoring or risk-based monitoring visits
On-site document management for source documents, CRFs, consent forms

Site Feasibility Assessment Checklist

Before selecting a site, sponsors and CROs should use a detailed feasibility checklist including:

Previous early-phase study experience (FIH, SAD/MAD)
Subject recruitment performance and demographic match
Availability of backup staff for continuity
Understanding of GCP and early-phase SOPs
Protocol-specific capabilities (e.g., imaging, biopsies, CSF collection)

Regulatory Compliance and Site Accreditation

For India: Site must be listed in CDSCO records and have DCGI-approved ethics committee
For the U.S.: Sites must follow 21 CFR Part 312 and have IRB accreditation
For EU: Sites must be registered in the EudraCT and compliant with CTR regulations

Common Pitfalls in Site Selection

Assuming all CRO-partnered sites are FIH-capable without audit
Inadequate sample storage leading to invalid PK results
Lack of 24-hour on-call physician for AE management
Failure to assess training and GCP documentation of site staff

Case Example: Oncology Phase 1 Site Preparedness

For a Phase 1 dose-escalation trial of a novel oncology compound, the sponsor selected a site with built-in PET scan facility, 24-hour medical coverage, and in-house pharmacists. The site had successfully handled three FIH oncology studies in the past 24 months. Their ability to provide real-time AE reporting and PK sample transfer within 3 hours of collection led to high data integrity and faster decision-making across cohorts.

Best Practices for Sponsors and CROs

Conduct site qualification visits (SQVs) at least 8 weeks before FPFV (First Patient First Visit)
Provide clear protocol training and roles/responsibilities matrix
Ensure parallel startup activities (regulatory, ethics, lab contracts) to save time
Develop a contingency plan for key equipment or staff absences

Conclusion

Phase 1 clinical trials require a level of precision and preparedness that goes beyond standard site operations. Choosing a site with the right combination of infrastructure, trained personnel, safety readiness, and regulatory awareness is foundational to success. Whether working with a dedicated early-phase unit or a hospital-based research center, your site partner should be a true extension of your quality culture—ready to execute with speed, compliance, and confidence.