Kapton Clinical: Accelerating Chronic Disease Trials Through Digital Management and Standardized Execution

What preparations must a CRO make to complete patient enrollment for a stroke project?

Screen for eligible patient sources in first- and second-tier cities.

Identify 52 stroke centers across 107 prefecture-level cities to conduct on-site verification of referral and enrollment processes.

Re-screened across 107 prefecture-level cities to identify, through on-site visits, hospitals with emergency green channels that enable direct referral and enrollment.

Streamline the enrollment process for eligible patients, including patient intake, examinations, informed consent discussions, and enrollment support.

Accurately convey the entire process to designated partner hospitals and implementers.

During this period, challenges include the dispersion of patient sources, completing patient screening and enrollment within a window of just a few hours, managing panicked patients and their families, and handling unexpected situations that may arise at any moment. Yet this is only the first challenge faced by clinical trials.

The tedious and complex process of identifying and screening patient sources is no longer novel to the Capton team. With a decade of deep engagement in the clinical management of chronic diseases, Capton adheres to the philosophy that “project technology + resource management = service products,” providing clients with comprehensive services throughout the entire clinical development lifecycle.

In the next decade, Capton will empower management through standardization, digitalization, and platformization to accelerate clinical processes.

During collaborations with Contract Research Organizations (CROs), clients primarily focus on ensuring cost-effectiveness and efficiency. However, inadequate communication between the two parties, coupled with significant disparities in upstream and downstream workflows, often makes it difficult for clients to understand and select CROs.Capton believes that the key lies in resolving the conflict between the roles of Party A and Party B, namely, the transfer of responsibilities, rights, and interests (liability, authority, and benefits) associated with clinical trials.

The integrated turnkey service is Capton’s strategic solution, namely its “Clinical Harvester” product. Pei Heng, Chairman and Chief Product Officer of Capton Pharmaceutical, explained, “The name ‘Harvester’ concretizes our service by drawing an analogy to large-scale harvesting equipment, capable of rapidly and efficiently translating preclinical research findings into the clinical and post-clinical stages.”

The turnkey service package will provide clients with full-cycle services throughout the entire clinical process, covering CROs, SMOs, vendors, and more.Sign a fixed-price closed-end contractIn practice, closed-end contracts can transfer the client’s responsibilities, rights, and benefits, resolving the traditional conflicts between sponsors and CROs driven by hourly billing—wherein the CRO’s efficiency determines its own revenue, thereby achieving risk sharing and mutual benefit.

In addition, Capton has established clear standards for consumer services, offering quality guarantees, progress-based betting agreements, and compensation for staff turnover in the event of unforeseen circumstances such as delays, thereby maximizing the protection of client rights. Clients can monitor the status of each stage of clinical trials in real time through a transparent operating system. Pei Heng noted, “Fixed costs and clear standards enable clients to conduct monitoring and management with confidence, facilitating ‘layperson oversight of professionals.’”

While establishing standards is straightforward, implementing them effectively poses a significant challenge. Efficient project management execution has thus become a core imperative for CROs. Capton’s proposed solution: deconstruct!

Step 1: Decompose clinical trials into 1,105 discrete actions and develop execution forms for 685 key challenges to guide action implementation across different scenarios.Pei Heng stated, “We have added SOC standard operating procedures, namely linking AD from to execution forms, and using more granular metrics to align with SOPs. To ensure high-quality data, we must have robust operational practices in place to guarantee the integrity of data generation.”

Step 2: Decompose project management into three dimensions—schedule, quality, and cost—and refine the generic project reporting meetings into daily schedule reviews, weekly quality meetings, and monthly cost reviews, thereby applying targeted management with different rhythms to address aspects evolving at varying speeds.

Step 3: Decompose employee performance into three dimensions—progress, quality, and cost—establish clear and transparent incentive mechanisms, and strengthen employees’ self-management.

Efficient, Layered Project Technical Management: Fulfilling Client Expectations for High-Quality, High-Success-Rate Clinical Trials. Rigorous Control at Every Milestone and Detail Is the Key to Enhancing Quality and Success Rates.

How Does Capton Achieve Execution? Striving for Three Times the Industry Speed While Keeping Costs at 50% of International CROs

In previous projects involving the management of moderate-to-severe Alzheimer’s disease, the eligibility criteria for clinical trial participants were extremely stringent, requiring untreated patients with moderate-to-severe disease. This posed a significant challenge for the research team, as patients diagnosed with moderate-to-severe Alzheimer’s disease at top-tier hospitals are routinely prescribed medication.

As this approach proved unfeasible in large urban hospitals, Capton and his research team began to consider where elderly individuals with overt clinical manifestations (moderate to severe Alzheimer’s disease) who remained untreated or even undiagnosed might be located. These individuals might have been diagnosed only at primary care facilities, or they might reside in nursing homes where their condition had gone unrecognized due to the absence of family members nearby. Based on this hypothesis, Capton visited more than 600 primary healthcare centers and hospitals, as well as 1,200 nursing homes, to identify eligible participants.

Pei Heng recalled, “The idea was sound, but initially we approached nearly 30 nursing homes and were unable to gain entry. Nursing homes aim to protect the elderly by shielding them from intrusive advertising and preventing fraud. We had no choice but to engage in conversations with directors, head nurses, family members, and the residents themselves to explore feasible ways to implement the project. The consensus ultimately reached was to volunteer at the nursing homes.” As a result, the entire team became “all-volunteer,” establishing a discourse-based evaluation system for subjective therapeutic outcome measures. Through communication, they assessed the severity of conditions and then encouraged family members to pursue treatment.

Once enrolled in the clinical trial process, due to the unique characteristics of neurological disorders, subjects’ subjective symptoms are influenced by numerous confounding factors such as emotion, motor activity, and sleep; therefore, close monitoring of data changes and detailed documentation of variables outside the trial protocol are required.

“At that time, the office was covered with charts showing the six-time score changes for each patient. That is how this project passed the on-site verification and blind review of the all-subjective special indicators,” said Pei Heng.“Since then, we have recognized that the origins of chronic diseases require long-term attention, accumulation, and cultivation. Capton has been engaged in this endeavor for nearly a decade.”

Resolving subject enrollment issues is a key secret behind Capton’s acceleration of the clinical development process.“In fact, in the field of chronic diseases, China does not lack a patient pool, but rather lacks qualified subjects who are truly eligible for clinical trials.” With long-term dedication to clinical practice in chronic disease management, Capton has developed a systematic framework for building a patient registry.

The primary issue is the asymmetrical distribution between clinical researchers and the subject population. Experts and R&D personnel based in first- and second-tier hospitals or laboratories are often the initiators and executors of new projects, whereas patients with chronic diseases are predominantly located in third- and fourth-tier cities. In response, Capton has established centers in 107 prefecture-level cities, forged partnerships with local hospitals, and deployed Clinical Research Coordinators (CRCs) to facilitate a two-way channel linking patient recruitment needs with enrollment willingness.

Another contradiction is the abundance of patients with chronic diseases, yet many fail to qualify as trial participants due to ineligible clinical indicators, incomplete evidence, or disease progression that does not align with study criteria, resulting in a shortage of enrolled subjects. Through online management, Capton organizes, conducts preliminary screening, and tracks these initially unqualified individuals, converting them into potential trial participants.

Based on this resource management system, Capton has laid out its strategy across six therapeutic areas for chronic diseases, covering 13 disease categories, including endocrinology, neurology, psychiatry, respiratory medicine, gastroenterology, and solid tumors. Regarding the acceleration of clinical progress, Pei Heng emphasized, “We will not attempt to cover all diseases within these six areas; instead, we will focus steadfastly on our core competencies. For each service product, we must conduct trials, streamline processes, design action forms, and plan management resources. Only in this way can we fulfill our commitments to clients—Strive to increase the speed of complex projects by one-third and that of routine projects threefold.”

Pei Heng divides the development of clinical trial-focused CROs into five stages, stating, “We have now transitioned from the traditional time-and-materials service model and entered the third stage: a scaled service industry characterized by standardization, process orientation, and modularization.”

Having achieved a standardized system, Capton is advancing toward the fourth-generation digital CRO and the fifth-generation platform-based, intelligent CRO.

As an asset-light CRO company, Capton has been continuously building its software platform while establishing standardized product processes and centralizing resource management. Since 2019, Capton has established a digital CRO headquarters, integrating project technical management and resource technical management into an online platform to enable multi-party, transparent, and real-time supervision and communication.

Entering 2023, Capton has planned to advance the digitalization and AI-driven intelligence project for its pharmaceutical industrial park in Daxing District, Beijing. “Capton has already begun incubating products and platforms. Over the next decade, we aim to establish a platform-based service company that provides more efficient, higher-quality, and cost-effective services for the re-development of clinical applications and mechanism innovation, thereby making the industry more vibrant and competitive,” concluded Pei Heng.

The asset-light CRO model has subtly yet decisively shifted from being labor-intensive and resource-driven to becoming digitalized and intelligent. It is foreseeable that in the near future, AI, big data, large language models, and integrated platforms will bring further disruptive changes to the CRO industry.

However, the essence of CRO services has never changed—project management, technical management, quality control, and resource integration remain the ultimate core competencies beneath the surface.