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Taimei’s CTMS increases inspection compliance to over 90%

Table of Contents

Background

Pharmaceutical innovation is surging, and the wave of digitalization is rising. In this article, we’ll look into Jacobio Pharmaceuticals and see how adopting a digital operation management platform helped improve the efficiency of project supervision and clinical trial inspection compliance.
 
Jacobio Pharmaceuticals (1167. HK) is committed to providing patients with breakthrough treatment options. The company’s ongoing research projects focus on six major tumor signaling pathways: KRAS, tumor immunity, tumor metabolism, P53, RB, and MYC, covering approximately 70%-80% of cancer types. The core projects aim to be among the top three in the world.  Jacobio’s laboratories are located in Beijing, Shanghai, China, and Boston, MA (USA), and have induced allosteric drug discovery platforms and iADC drug development platforms. The company’s vision is to work hand in hand with its partners to become a globally recognized leader in drug research and development.”

Target

Through online clinical project management and document management platforms, companies are able to manage clinical trial projects digitally, standardize the document archiving process, and promptly discover unarchived documents.

Whether from the perspective of regulatory supervision or corporate development, the digitization of clinical trials was essential to developing clinical research – an aspect the Jacobio clinical medicine team leaders were well aware of. Before Jacobio’s clinical research projects could begin, they initiated the selection of digital management systems.
 
“After comparing different digital management systems domestically and abroad, we chose Taimei Technology because their system was standardized, flexible, and quick to set up. We were able to use their system in our domestic clinical research as well as our foreign clinical research. The Taimei platform met the need for efficiency for innovative life science companies. Additionally, we wanted to work with domestic suppliers interested in ongoing clinical research improvement to complete the Jacobio clinical research project and contribute to overall clinical research in China.”
 
——Zhang Yucheng
Director of Clinical Operations at Jacobio

Outcomes

1. Using the CTMS system to track the execution of inspection tasks quickly, automatically generate confirmation letters/follow-up letters, and intelligently write and approve inspection reports, in addition to utilizing mobile apps, has significantly improved the work efficiency of CRAs.

2. Long-Term Stability of Monitoring Clinical Trial Inspection Compliance: Even under the COVID-19 epidemic prevention and control measures, and with the frequency of monitoring significantly increasing since the Spring Festival this year, the rate of timely submission and approval of monitoring reports at the research center has remained above 90%. Taimei’s CTMS system guarantees excellent supervision quality.

3. Connectivity Between CTMS, eTMF, and TMS Systems: Through the course distribution and training result tracking within Taimei’s eCollege training system, it ensures that even rapidly expanding teams can maintain clinical trial inspection compliance with the use of the system and ensure the regular and orderly development of clinical project management.

4. Assisting Overseas Projects: CTMS can switch between Chinese and English language environments and customize English monitoring report templates. Jacobio has already used CTMS and eTMF in a clinical study jointly conducted by China and the United States.

Challenge

GCP Chapter 5: Clear requirements for monitoring

GCP clearly stipulates the requirements of supervision. After supervision, the supervisor must promptly report in writing to the sponsor. In addition, they must follow up on the work summary in the supervision report regarding deviations from the plan and problems discovered during supervision and then create and save a document of their findings.
 
  • Monitoring refers to the action of monitors supervising the progress of clinical trials, as well as ensuring implementation, recording, and reporting of clinical trials are complete per trial protocols, standard operating procedures, and relevant laws and regulations.
 
  • The monitoring report refers to the written statement submitted by the monitor/supervisor to the sponsor after each on-site visit or other clinical trial-related communication per the sponsor’s standard operating procedures.
 
  • The sponsor’s standard operating procedures are written instructions describing the step-by-step process supervisors must routinely follow to supervise properly. Supervisors should follow SOPs the same way every time to guarantee that the research remains consistent and complies with industry regulations.
 
  • The sponsor should implement clinical trial monitoring. The scope and nature of monitoring will depend on the clinical trial’s purpose, design, complexity, blinding, sample size, and endpoints.
 
  • The monitor should promptly report to the sponsor in writing after each review; the report should include the review date and location, the reviewer’s name, the researchers’ names, and the names of other personnel with whom the reviewer came into contact. The report should include all details of the review. A summary of the inspection work, a statement of the problems and facts found in the clinical trial, deviations and defects from the trial plan, and the conclusions of the inspection. The report should describe the corrective measures taken or the plan to address the problems discovered during the inspection to ensure that the trial follows the recommended protocol implementation. Reports should provide sufficient detail to review compliance with the monitoring plan. The sponsor should review and follow up on the issues in the monitoring report and keep them as documents.

Solution

1. Configure the SOP schedules for the center's monitoring visits and establish a standardized monitoring and approval process

Configure the SOP schedule (domestic and foreign versions), including:
 
  • Center selection visit report
 
  • Center start-up preparation list
 
  • Center start-up visit report
 
  • Routine monitoring report
 
  • Center closure visit report and confirmation letter/follow-up letter
 
  • Establish standardized monitoring forms for planning, monitoring issues, protocol violations, subjects, ICF, SAE, etc., unified CRA data entry standards, and the approval process in the system.
 

eCooperate - clinical trial management system screenshot 1. clinical trial inspection compliance

2. Inspection visit reporting system configuration

 

A. Configure the inspection visit report template to automatically extract the primary data from the report and link it to other sub-module data. This configuration improves the data entry efficiency of CRAs and allows for easy reporting, verification, and statistical analysis of the module data, such as:
 
  • Subject information (screening/enrollment/exit, etc.)
 
  • Verification of Informed Consent Form (ICF)
 
  • Serious Adverse Events (SAE)
 
  • Protocol violations (Managing protocol violations is an essential part of ensuring the quality of clinical trials)
 
  • Problems left over from the last audit (One of the core difficulties in auditing. If minor problems cannot be resolved in time, they may become bigger problems that take double the time to fix)
 
  • Problems discovered during the current audit (CRA inspection frequency is on a set timeline. Issues arise if someone is trying to solve a problem during an inspection without immediately contacting a researcher first.)
 
B. Compliant Electronic Monitoring Report Signature Page: After the monitoring report is written and approved online, an electronic signature page is generated directly on the last page of the report, including the signature of the submitter, the signature of the approver, and the timestamp. The system can automatically generate this electronic signature page at the time of report submission. The encoding of the signature file meets the compliance requirements of the “Electronic Signature Law of the People’s Republic of China” and the US federal law “21 CFR Part 11.”
 
eCooperate - clinical trial management system close out visit report. clinical trial inspection compliance
 

3. System training and useful practices

Organize training for the clinical operations team, including creating a monitoring visit plan, sending confirmation letters, writing reports after monitoring execution, and following up on confirmation letters. When combined with the convenient functions of the system, the efficiency of report writing is significantly improved.

  • Planned Task Reminders: Monitor reminders for planned tasks, report-writing, and target submission deadlines.
 
eCooperate - clinical trial management system screenshot 2. clinical trial inspection compliance
 
eCooperate - clinical trial management system screenshot 3. clinical trial inspection compliance
 
  • Automated Template: Based on the information in the monitoring plan/monitoring report, the system can automatically generate confirmation letters/follow-up letters, eliminating the trouble of manually writing them. The system also allows easy, one-click sending to researchers.
 
eCooperate - clinical trial management system screenshot 4. clinical trial inspection compliance
 
  • Intelligent Report Writing: CRAs can quickly recall data from previous inspection reports, saving time on filling in duplicate information.

  • Automatic Report Archiving: CRAs can automatically archive approved inspection reports, confirmation letters, and follow-up letters in eTMF.

  • Mobile Office: Through the exclusive mobile app, CRAs can update supervision data anytime and anywhere, record a supervision issue or plan violation, and complete the writing and submission of the entire report. PMs can also complete report approval on the mobile app.
 

4. Establish internal training courses to empower growing clinical operations and promote clinical trial inspection compliance

The requirements for supervision in the SOP are combined with the system’s operational training to produce training courseware and videos published in Taimei’s eCollege training system. Within the training system, the courses can automatically be distributed to the operation team and new CRAs, ensuring that all members can quickly master the use of the system.

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