CLINICAL TRIAL NETWORK
The clinical engine behind every trial
Our clinical site management network is the clinical center network that runs AllianceXPartners-structured trials — built from the ground up to withstand the level of scrutiny a US sponsor’s regulatory and quality team will bring before relying on the data.
Built for sponsor due diligence, not just trial execution
US biotech sponsors and their regulatory and quality teams ask the same hard questions before agreeing to rely on data generated at any ex-US site. We organized our business around answering those questions before they’re asked — not after a sponsor’s audit finds a gap:
Regulatory standing & site qualification
Investigator & staff qualifications
GCP compliance & quality systems (ICH E6(R2))
Data integrity & systems (21 CFR Part 11)
Monitoring, QA & audit readiness
Patient population & recruitment (ICH E17)
We maintain sponsor-facing readiness on ethics committee and informed consent processes, investigational product and supply chain, biological sample handling and export, safety and pharmacovigilance, and data privacy and geopolitical risk — each mapped against the specific questions a sponsor’s regulatory and quality team is trained to ask.
A two-track site footprint
Every trial we run is organized into two tracks within one protocol. The FDA track runs across the United States, the EU/ICH region, and non-restricted EAEU states producing the dataset a US sponsor can put in front of the FDA. The EAEU registration track, run separately, supports local registration and post-marketing study only, and isn’t included in the FDA data package. This separation is structural, not procedural — built into site selection and data governance from the start.
For clinical sites
Joining our clinical site management network means access to a pipeline of sponsor-funded, FDA-relevant trials — sourced, structured and contracted by AllianceXPartners, so sites focus on trial execution and quality rather than sponsor origination. Sites that meet ICH-GCP and FDA-readiness standards are prioritized for inclusion in upcoming programs.
AllianceXPartners 