PI Networks: A Strong KOL Does Not Equal a Delivery-Ready Network

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A high-quality clinical research network often begins with a leading site that combines access to patients, technical capabilities, and extensive research experience.

Consider the team led by Professor Jiong Shi at the First Affiliated Hospital of USTC (Anhui Provincial Hospital), a verified partner of GCP ClinPlus. Publicly available information shows that the team has:

Established a cognitive impairment cohort in 2018, enrolling more than 600 patients with Alzheimer’s disease
Developed biomarker assessment capabilities involving blood, cerebrospinal fluid, and Aβ PET, while also conducting Aβ/Tau PET imaging
Established dedicated memory clinics at both the main and southern campuses
Led or participated in more than 50 multinational clinical trials

These capabilities demonstrate the strength of an individual site—but they do not automatically create a delivery-ready multicenter network.

ICH E6(R3) states that investigators should demonstrate, using retrospective or currently available data, their potential to recruit the required number of eligible participants within the agreed timeline. They must also have sufficient time, qualified staff, and adequate facilities. Sponsors remain responsible for selecting investigators and institutions and maintaining appropriate trial oversight.

A CRO must therefore translate the strength of an individual site into four verifiable network capabilities:

Validate the actual eligible patient pool against protocol criteria—not just overall clinic volume
Build a tiered site portfolio based on competing trials, team capacity, and facilities
Integrate ethics review, contracting, study start-up, and evidence-based recruitment forecasts into one plan
Maintain consistency across sites through standardized training, quality oversight, and risk-escalation mechanisms

A true PI network is not simply a list of experts. It is an operational network capable of starting studies, recruiting participants, executing protocols, and consistently delivering high-quality data.

With 23 years of clinical research experience, more than 2,300 projects, and over 200 multinational clinical trials, GCP ClinPlus supports clinical development in China—from PI and site matching and feasibility assessment to study start-up, recruitment management, and quality oversight.