Hippocrates | Clinical Research Solutions: The O-Trial System Fully Empowers Clinical Trials

In the field of pharmaceutical R&D, rigorous, efficient, and compliant clinical research is the key to successful drug launch. Hippocrates's clinical research solution, O-Trial 2.0, covers the entire clinical research process, delivering an integrated, end-to-end service from site initiation to site closure for sponsors, CROs, SMOs, and clinical research center institutions.

O-Trial weaves four core concepts — Process, Quality, Decision, and Budget — throughout its product design:

Process — Strict control, fully in hand;

Quality — Quality is the foundation of clinical trials;

Decision — Multi-dimensional data to help make optimal decisions;

Budget — Improve quality and reduce cost. Through end-to-end digital management and data-driven operations, O-Trial helps all parties in clinical trials advance every research project efficiently, with high quality and full compliance.

01 About O-Trial

O-Trial is a detail-focused management software for SMO companies, enabling PMs, CRCs, and PIs to communicate and collaborate on a single platform. Through more rational work-hour classification and allocation, it reduces cost and increases efficiency, while allowing PIs to quickly review project progress on one platform and adjust strategies in a timely manner.

02 “128+X” Overall Architecture

Built on a foundation of “Clinical Research Interconnection + Data Integration Platform,” O-Trial 2.0 integrates common data to push execution granularity down to the smallest project unit, creating a product ecosystem of “1 Integration Platform + 2 Supporting Platforms + 8 In-house Business Modules + X Extended Services”:

The platform serves all parties in clinical trials — research centers/institutions, sponsors, CROs, and SMOs — enabling cross-role, cross-site collaboration and data integration through the unified O-Platform.

03 Platform Service Architecture

Delivered as SaaS and centered on “integration & optimization and data interconnection,” the platform covers the complete project management lifecycle — research planning, research execution, site initiation, and site closure — while running through two main threads: clinical quality and cost reduction with greater efficiency. Its core capabilities include:

Project dashboards provide an overall project overview for full visibility; tracking controls support various tracking operations to ensure real-time monitoring of project progress; closed-loop query management rapidly responds to and resolves issues to safeguard quality; task management effectively coordinates project tasks to improve collaboration efficiency; AE/SAE management handles adverse events professionally to ensure patient safety; and digital tools such as electronic payment and e-consent improve operational efficiency and information security.

04 Core Product Modules

(1) QuanYanKong: Data Dashboard — the Clinical Trial Right Before Your Eyes

QuanYanKong is built around the “data dashboard,” helping project managers grasp the full picture of a project in real time. Its value proposition — “the clinical trial right before your eyes” — consolidates scattered project data into multi-dimensional, traceable dashboard views that support timely decision-making.

(2) QuanLinTong: Integrated Collaboration Between PM/CRA and the Execution Side

1. PM/CRA Full Control over Real-Time Data

QuanLinTong gives project managers (PMs) and clinical research coordinators (CRAs) full access to real-time data — ongoing projects, project types, therapeutic areas, trial phases, and extension schedules — all within reach. It supports viewing project details from a site perspective for more meticulous management, and enables PM/CRA to collaborate efficiently with CRCs on the platform, quickly resolving queries through closed-loop query management to keep projects running smoothly.

2. PM/CRA Reporting Made Effortless

No longer wait for collaborators to aggregate data — view project data from multiple angles and keep firm control of progress. No longer struggle over report preparation — see the whole project on one screen, drill down to the smallest data granularity, and export personalized reports. Features include report template and contact management, automatic data compilation, weekly scheduled auto-generation, and customizable report dimensions for tailored reporting.

3. PM/CRA Workspace Rapidly Consolidates Project Information

Project execution workspace: The PM/CRA workspace provides early warnings for pending tasks, clearly records completed visits for easy traceability, reduces the risk of misoperation, and automatically consolidates execution data. Project management workspace: The CRO PM workspace tracks end-to-end progress in real time and oversees projects from multiple perspectives, consolidating tasks to monitor multiple indicators such as quality, work hours, and progress.

4. Execution Side: CRC Empowered Like a Tiger with Wings

The execution side comes with built-in site SOPs and operational SOPs, intelligently calculated visit lists, and follow-up calendars, serving as a CRC's “work companion” and “smart clinical mentor by your side.” It helps organize work, keeps data flowing smoothly, and stabilizes site operations, enhancing CRCs' own reputation and helping them outperform their peers.

(3) QuanKuaiQi: Rapid Site Start-Up (SSU)

QuanKuaiQi transforms the SSU (site start-up) process into online operations through step forms and workflow configuration, built around three capabilities: “site documents, standardized operations, and progress tracking”:

Site documents: Built-in documents and special requirements for hundreds of sites, protocol interpretation, one-click generation of multi-site essential documents, and intelligent document drafting reduce repetitive work and shorten site initiation time. Standardized operations: Platform-based unified standardized operations with an embedded quality control system reduce project delays caused by human error; complete guidance and records lower the execution threshold at every SSU step, so even newcomers can complete them. Progress tracking: Automated site initiation progress tracking ensures the SMO execution team and sponsors can monitor each site's SSU progress, document progress, existing issues, and task completion in real time.

(4) QuanLinFu: Clinical Research Electronic Payment

QuanLinFu is “the earliest provider of clinical research electronic payment services in China,” delivering integrated electronic payment capabilities spanning system workflows, bank payment, online agreements, and real-time fund arrival.

After a subject signs informed consent and uploads their bank card information on a mobile device, the clinical research coordinator (CRC) selects the corresponding visit on a PC and submits a stipend disbursement request (about 2 minutes). The investigator then reviews and approves the stipend on a mobile or computer device (about 1 minute). Finally, the system backend technically reviews the de-identified information and disburses the stipend (with a configurable uniform disbursement time).

Market performance: No. 1 in domestic market share, with over 500 projects, approximately 40% project coverage, and more than 70% of clients being multinational or innovative pharma companies.

05 Usage Results: Quantified Value

From the very start of a project, a complete quality system is deployed to fundamentally change the process from “monitoring then remediation” to one driven by tasks — achieving “strong task reminders, with no omissions and no violations.”

06 O-Trial Definition and Value by Role

（一）What is O-Trial

O-Trial is a detail-focused management software for SMO companies, enabling PMs, CRCs, and PIs to communicate and collaborate on a single platform. Through more rational work-hour classification and allocation, it reduces cost and increases efficiency, while allowing PIs to quickly review project progress on one platform and adjust strategies in a timely manner.

（二）The Value the System Brings to Each Role

Through efficient collaboration mechanisms such as PM–CRC training and project management and CRC–PI learning and project execution, the platform ultimately achieves the scaled-efficiency goal of “one PM managing more projects and one CRC executing more projects.”

07 Detailed Functions

(1) Intelligent Protocol Management and Follow-Up Calendar

It supports protocols for Phase I, II, and III trials and adapts to intensive PK and different blood sampling plans. Built-in site SOPs and operational SOPs let every CRC quickly review and execute tasks per the SOP, with intelligently calculated follow-up To-Do Lists and follow-up calendars. It also continuously maintains site SOPs and converts them into system data capabilities, extracting concrete execution descriptions from site SOPs and pushing them to physicians/CRAs/CRCs to lower execution cost and difficulty and reduce project costs from staff turnover — all while continuously iterating best practices and recommending content intelligently by project.

(2) Patient Mobile App

Patients can efficiently schedule follow-up visits and view treatment progress at any time, while the system reminds them of medications and diary cards. Through structured data collection on the patient mobile app, sponsors obtain more comprehensive and statistically meaningful subject data.

(3) PI/CRC and Patient To-Do Integration

The To-Do List for each follow-up is calculated and pushed to PI/CRC and patients, with two-way confirmation of task completion — reassuring patients while reducing workload and errors. CRAs can stay in sync, manage proactively, and truly take remote control of the site process.

(4) Project Management, Execution, and Site Data Dashboards

Project management data: Real-time visibility into all projects, with different phases, tasks, milestones, key events, reports, and documents interconnected and providing instant feedback. Execution and site management data: From both project and site perspectives, events such as visit window overruns, issue discovery, and AE/SAE trigger real-time alerts and timely improvements, supporting decision-making and resource optimization. One click from issue data reaches the execution content, linking management and execution by cause — a sharp contrast to the hollow “leadership-facing” BI dashboards on the market.

(5) Multi-Role Workspace

The project management workspace and project execution workspace serve the management and execution sides respectively: physician/CRA/CRC workspaces give full control over pending work, while CRO/sponsor/SMO PM workspaces fully manage project to-dos. Task consolidation across workspaces drives progress through data, bringing all pending work together on one screen.

(6) Project Planning and Milestone Management

Comprehensive project planning supports research timelines, project plans, and site plans. Project and site milestone management plan project milestones and link execution progress to milestones, achieving unified control over milestones across all sites within a project.

(7) Work-Hour Management

It covers the full process of work-hour plan management, operational work-hour entry, work-hour approval, and work-hour management data; links work-hour entry to each follow-up visit, supports entry of hours outside projects, and supports work-hour utilization calculation and bonus data extraction.

(8) Weekly/Monthly/Inspection Report Management

It covers report template and contact management, weekly scheduled auto-generation, automatic data compilation, automatic reminders, and management data. CRA/CRC weekly reports are auto-generated with to-dos and reminders, supporting export or multi-party delivery; about 70% of weekly reports are automatically compiled, with highly real-time data and back-filling for prior periods. CRO/SMO PM research progress reports (external monthly reports) likewise support auto-generation, to-do reminders, and multi-party delivery. Customizable CRA monthly report templates auto-link large volumes of data, greatly reducing the time CRAs spend writing reports and enabling issue tracking and resolution.

08 Cases

Johnson & Johnson, Haisco, IQVIA, I-Mab, Shutaishen, IASO, East Asia Pharmaceutical, KeyMed, Shanghai Pharmaceuticals, Hengrui, CSPC, Junshi Biosciences, Bayer, Humanwell, Sunshine Guojian, Qilu Pharmaceutical, Roche, arctic VISION, Salubris, GlaxoSmithKline (GSK), United Laboratories, Zai Lab, Chia Tai Tianqing, Pfizer, Allist, Kelun Group, TOT Biopharm, Novartis, Hisun, FronThera, and other renowned pharmaceutical companies at home and abroad.