Integrated Clinical Trial Management System: Establishment and Efficiency Assessment

Abstract

In the hospital settings, performing clinical trials is an intricate process that is generally hampered by several institutional, technical, and record-keeping challenges. Hence, we evaluated the effectiveness and efficiency of our established integrated clinical trial management system (CTMS) in terms of analyzing core functionalities, assessing integration with existing systems, measuring time, and cost efficiency. Our CTMS (version 10.1, August 2024) is integrated into one of the largest teaching hospitals with the human research audit system, biobank management system, biological sample management system, enterprise resource system service, institutional review, and single sign-on system. The total number of trials, subjects enrolled, products developed, investigators, new drug and indication, devices, and new medical technology are found to be 913, 53969, 851, 159, 784, and 98, respectively, with a total budget of 3539846777 New Taiwan Dollar (approx. 106881045 US$). Our CTMS is efficient in updating data, with improved user interface experience, and controlled access according to the defined policy. Integrating CTMS with other components provides effective tracking and monitoring of the clinical study. Conclusively, our integrated CTMS is designed for comprehensive evaluation and supervision of clinical trials, supporting full-process data management and seamless integration with clinical systems of hospitals through a unified interface. The increasing number of trials, subjects enrolled, products developed, investigators, new drugs and indications, devices, and new medical technology indicates its robustness and efficacy.

INTRODUCTION

Clinical trial management systems (CTMS) provide a real-time tool that lowers the chances of errors and improves communication among clinical trial stakeholders. Various commercial CTMS software are being utilized in clinical trial studies. However, academic medical centers/universities/hospitals have found commercial CTMS software costly to use along with operational challenges.¹⁾ CTMS also provides solutions to integrate and manage various components of clinical trial studies, such as study, subject, investigational product, clinical trial monitoring, regulatory compliances, accessibility, and so on.^2,3) The manual or paper-based management of clinical trial studies required manual documents that were labor-intensive and complicated to store and communicate information generated during trials. The recent progress in information and Internet technologies has provided a way to effectively manage clinical trials with a low margin of errors in real-time. Commercial CTMS software is widely available for managing clinical trials; however, it needs to be customized according to the needs of trial-conducting institutions/centers to manage clinical trials effectively.⁴⁾ Additionally, aligning the hospital information system (HIS) is challenging for commercial CTMS. Specifically, implementing and maintaining HIS in managing clinical trials is expensive due to multiple factors, such as scope, scale, and usage. It also involves substantial upfront costs, including software licensing, hardware upgrades (e.g., servers, workstations), and integration with existing CTMS or trial-specific modules. Customization to support trial functions further escalates expenditures. Information technology-related delays in care delivery, applicable to trial management, also increase indirect costs.⁵⁾

Data management in clinical trials involves multiple activities such as planning, monitoring, implementation, data accessibility, data entry, data protection, data validation, data presentation, and correction.^2,3) CTMS should be effective in generating case reports, building databases, mining data, providing medical coding, data locking, and addressing issues related to data discrepancy and its resolution.

The development of CTMS requires expertise in project management, scientific/technical knowledge, information technology, system engineering, and ethical and regulatory awareness.⁶⁾ HIS is an integrated hospital clinical and administrative management system primarily used to maintain patient records. It includes an electronic health record (EHR) component, which presents patient information and allows for the insertion, searching, and editing of records. The requirements for HIS systems vary based on hospital needs, making the synchronization of CTMS with multiple HIS systems a challenging task for multisite clinical studies. Recent studies have demonstrated the successful integration of HIS, patient recruitment system, users, and clinical requirements into the CTMS.²⁾ The HIS system requirement varies according to the hospital requirements, and synchronizing CTMS with multiple HIS systems is challenging for the development of CTMS.

Considering the need for an economical CTMS that could easily integrate different HIS systems of various hospitals, we present our CTMS according to the requirements of hosting institutions (Fig. 1). Considering the need for an economical CTMS that could easily integrate different HISs and fulfill specific purposes of academic institutions/hospitals, we present our CTMS, which might suit the requirements of any hosting institution to support decision-making in healthcare service. We specifically assessed the effectiveness and efficiency of CTMS in managing the clinical trials, from planning to completion. Functional components of core CTMS features were analyzed to determine their efficacy in trials. The interoperability of CTMS’s integration with ancillary systems (such as Electronic Health Records, etc.) was evaluated to assess data exchange accuracy and efficiency. We also quantified resource impact by measuring the CTMS’s effect on trial duration and costs. Eventually, we aimed to provide insights that can improve the design, implementation, and utilization of CTMS for better clinical trial outcomes.

Fig. 1. Outline of the CTMS and Its Integration with the Existing ERP Systems of a Teaching Hospital Consisting of 3 Affiliated Hospitals

ERP: Enterprise Resource Planning, SMTP: Simple Mail Transfer Protocol, API: Application Programming Interface. SSO: Sign-On System.

MATERIALS AND METHODS

Ours is the first integrated CTMS for a group of a major medical university and its affiliated hospitals in Taiwan. Each institution has its own ERP along with the human research audit system, biobank management system, and biological sample management system. The Institutional Review Board (IRB), Clinical Research Center (CRC), Biobank (BB), and Data Safety Managing Section (DSMS) are also integrated with the CTMS. The Principal Investigator (PI) applies for IRB review of a new clinical trial and completes the research application basic information. The CRC uses research application material for clinical trial preparation items such as budget planning, site feasibility surveys, and seeking research coordinators. While the trial is being executed, the DSMS can simultaneously conduct IRB and CRC audits. During the clinical trial implementation, if the subjects agree to store their samples in a biobank, the research application basic information established in the CRC is directly linked to the biobank to retain their specimen, reducing redundant data entry, saving time, and minimizing input errors.

Furthermore, specific requirements for components such as study approval, regulatory compliance/ethical requirements, subject management, investigational product management, and site management need to be fulfilled by the CTMS. Moreover, we also addressed the need for clinical data management and synchronizing the clinical database to the HIS. Our CTMS integrates with hospitals’ ERPs for HIS and provides features such as automation, real-time transmission, access control, and other requirements. We have summarized the essential features of the essential components of CTMS in Fig. 2.

Fig. 2. Essential Characteristics of Essential Components of CTMS

CTMS: Clinical trial management system.

Study Project Approval Management

In a clinical study, project approval involves multiple persons and steps. Thus, multiple access and real-time communication are necessary to avoid errors or delays in project approval. This component of CTMS should provide the following characteristics: process optimization, auto-generation of the task, uploading of required documents, including project proposal/materials, material annotation, remote submission of the project application, and real-time communication and messaging facility. In addition, the institutional review board will have access to the ethical forms and other related documents such as project title, principal investigator, trial period, and Pharma/CRO information. Moreover, the data could be easily imported from HIS.

In this section of CTMS, clinical study protocol and application for project approval can be uploaded online. Furthermore, the autotask generation will forward the application and protocol to the concerned authority or review officers for initial review. The review officer can forward the application if satisfactory, otherwise, he/she can write back for further clarification or information. Similarly, the application can be moved from one level to the next and will finally reach the director of the study project for final approval and be uploaded to the CTMS portal.

Budget Management System

An efficient budget management system is required to manage the high clinical trial cost.⁷⁾ Cost management significantly contributes to the timely completion of the study within the allocated budget without affecting the quality. Proper budget planning and tracking of study expenses provide an opportunity to handle unexpected costs and financial challenges. Preparing the actual budget is the first step for proper financial management and it is essential to identify billing activities and ensure sufficient funds for the study’s completion.⁸⁾ Lack of adequate budgeting could result in loss as all the clinical study requirements must be fulfilled irrespective of the financial aspects. Therefore, the fund should be allocated appropriately for protocol-specific requirements such as additional diagnostic, lab, and pathological tests, including radiological and specific tests related to drug toxicity.⁹⁾ Budgeting includes both fixed and variable costs.¹⁰⁾ The internal cost is prepared for protocol review, specific services, and tests conducted.¹¹⁾ Billing should also carefully evaluate what parts of the daily routine are covered by insurance and charge bills to the sponsor for non-routine daily care.⁷⁾ The study sponsor should also be billed for the specific protocols that are not a part of standard care.^7,12) Additionally, the success of the clinical studies depends on the dedicated research and supporting staff, the proper budget allocation for recruitment, training, and maintaining the staff. Thus, adequate budget allocation for sufficient manpower is integral for success of the clinical trial. Whenever the budget for staff is considered, it is necessary to consider all essential tasks, including screening patients, obtaining informed consent, conducting patient visits, completing accurate source documents and case report forms, maintaining regulatory documents, and communicating with the sponsor and contract research organization and should be properly billed to the sponsor. Our CTMS provides a detailed spreadsheet to assess fund requirements and the source of funds, and track the expenses with controlled access. The spreadsheet also provides the tools to access the cost of each in-line protocol, item, service, and test to determine the billing status.

Subject Management System

CTMS should provide an effective way to monitor and plan subject-related activities in clinical trials. Notably, the timely recruitment of desired subjects in sufficient numbers is a challenging task and the first criterion for completing the study within the allocated budget.¹³⁾ The lack of a proper number of subjects often leads to delays or termination of studies. Subject screening inclusion/exclusion criteria should be defined appropriately, checked, and recorded for patients.^14,15) The record of recruitment methods and data is related to registries such as patient demographics, diagnosis, disease, product administered, and treatment details. The data registered are organized to fulfill the study’s specific requirements/information.¹⁶⁾ Moreover, patient-related information in the subject management system is integrated with HIS, which could assist in recruiting patients for clinical study.^17,18) The subject management system will record all information related to each visit during the study. CTMS should provide specific features like study participant assignment (to assign investigators, nurses, clinical research associates, and coordinators and allow respective permissions), protocol designs (automation of study plan, mapping of protocol with executable events), rule developments (for inclusion/exclusion criteria, drug randomization, number generation, etc.), list of running projects with access management, subject list (with coded pattern to monitor the status/progress), tracking of subject recruitments by linking it with hospital information system, and subject study process management (manage the entire process including subject recruitment, visit information, study contents for screening, randomization, inspection, investigational products).¹⁸⁾ Our CTMS provides all the necessary tools to manage recruitment, subject information, randomization, and monitoring.

Contract Management System

This entails managing the contract for negotiation and fulfilling the agreed requirements for sponsored studies to complete the study within budget timely.^19,20) An initial negotiation is crucial for defining the budget, recruitment criteria, resources, process, protocols, barriers, and management.²¹⁾ The contract should also carefully address the basic and sensitive points.²²⁾ The contract management system provides tools to address, discuss, and document other issues related to patent protection, study data, confidentiality, indemnification, subject injury, publication, intellectual property rights, and reimbursement details. Moreover, research personnel should be assigned as a contact point to monitor the execution of the contract in a timely manner. In addition, e-site-specific requirements should be communicated to third parties, and standard operating procedures should be developed and used to direct staff to implement the process to complete the task without any major conflict or inconsistency.²²⁾ Thus, the contract management system is a quintessential feature of negotiating, monitoring, and fulfilling the contract’s requirements.

Report Generation System

Organizing data and preparing reports during clinical trial studies are regular requirements to track the progress and challenges during the study. The report is also required to communicate the requirements, progress, and challenges to stakeholders. Clinical data management is needed to prepare reports and other relevant information. Notably, case report form (CRF) designing, CRF annotation, database designing, data entry, data validation, discrepancy management, medical coding, data extraction, and database locking are essential components for clinical data management and report generation.²³⁾ The paper-based CRF has been replaced with electronic CRF (eCRF) due to better data quality, online discrepancy management, rapid data lock, lower transcription mistakes, and mitigation of illegible handwriting.²⁴⁾ Moreover, electronic data capture will further automate the data and statistical analysis. In addition, CRF is a vital quality document that ensures data capture required by the protocols, regulatory compliance, data verification, and site-work flow and reduces data duplication.^18,19) Automation of data extraction from electronic health records (EHR) to eCRFs lowers the data entry burden, abstraction, errors, and improves data quality and safety.²⁰⁾ In addition, automation of data capture, analysis, and report preparation enhances the quality of the study with reduced effort of study personnel. Moreover, the electronic storage of study documents such as protocols, investigational product brochures, safety measures, informed consent forms, and regulatory documents provides quick access to documents, resulting in rapid and quality study.²¹⁾ The trial master file (TMF) is the source of all necessary documents to be used by the stakeholders (investigators/institutions, sponsor body, clinical research organization (CRO), auditors, inspectors, directors, etc.) to complete the study in accordance with regulatory and GCP requirements.²²⁾ Documents stored in TMF ensure the rights and safety of the patients, along with the authenticity and quality of the data.²²⁾ The electronic trial master file (eTMF) is an electronic document management system that provides storage and access to all necessary TMFs. The eTMF offers real-time access to stakeholders, including sponsors, that ensures the quality of the study, regulatory and SOP compliance, compliance of workflow, and real-time resolution of any deviation.

Permission and Business Management System (Access Management System)

The clinical trial study involves various participants and stakeholders, so controlled access to the relevant information to the participant is necessary to ensure the safety and quality of the study. Thus, our CTMS access is integrated with the hospital information system to ensure controlled access.

Email and Push Notification

Electronic communication is necessary for rapid communication to ensure the study’s quality and to maintain future communication records. Push notifications for to-do and email are integrated to avoid any omission of tasks and messages due to human error.

RESULTS

As of August 2024, our CTMS contained the total number of trials (Fig. 3A), subjects enrolled (Fig. 3B), products developed (Fig. 3C), investigators (Fig. 3D), new drug and indication (Fig. 3E), devices, and new medical technology (Fig. 3F) found as 913, 53969, 851, 159, 784, and 98, respectively, with a total budget of 3539846777 New Taiwan Dollar (approx. 106881045 US$) (Fig. 3G).

Fig. 3. Change in the Number of (A) Trials, (B) Enrolled Patients, (C) Products Developed, (D) Investigators, (E) New Drugs and Indications, (F) Devices and New Medical Technology, and (G) Budget in CTMS between 2015 and 2024

Development of System Architecture and Data Management

CTMS design requires user interface (UI/UX), database modeling, data storage, data interchange, data safety, and system architecture. The CTMS design should follow Good Clinical Practice (GCP) and national guidelines. CTMS designs were sub-classified into Project approval and Ethical Review management, Budget and Financial management system, contract management system, permission and business management system, subject management system, report generation system, Access Management System, and Email/push notification system and integrated with the single sign-on system. In addition, the CTMS data are also synchronized with the Human Research Audit System, biobank management system, biological sample management system, institutional review management system, CRC, and DSMS, ERP systems of three major medical universities for data security, integrity, and clinical trial data transmission. Data privacy and security are ensured using permission control, log records, and traceability for logging and data updating.

Study Project Approval and Ethical Review Management

The CTMS includes necessary tools for project review and ethical approval is facilitated by the institutional review management system of CRC. Our project and ethical review management system prioritizes work in order of workflow. The essential features for study and ethics management include project approval management, to-do-task lists, project lists, document management, contract management, initial meeting management, investigator management, CRC management, ethics review, and conference management for the ethical committee (EC). It also provides tools to EC for protocol/protocol amendment/deviation/violation review, and severe adverse event (SAE) report/review.

Financial and Budget Management System

The financial and budget management system of CTMs provides tools to maintain financial and budget records for project funding amount, workload records, budget management, payment and allocation, and expenditure management. Payment and allocation management provides tools for recording participant fees, payment allocation, and the payment process accordingly. It also provides tools for managing expenses, project funds, and the budget. The records of workload statistics are related to project contracts, billing, cost accounting, visit hours, and so on.

Subject Management System

The subject management system maintains records of subject screening/recruitment/violation verification, subject visit information, study participant assignments, protocol configuration, treatment randomization, rule configuration, electronic case report form (e-CRF), adverse events (AEs)/protocol deviation changes, and investigational product records; subject’s status such as withdrawal, and termination, medical records, medical examination results, and e-CRF data filling are also being managed under the subject management system. Furthermore, the subject management system is integrated with CRC, TMUH, WFH, and SSH data management. The privacy and safety of subject data are ensured with encryption and controlled access.

Contract Management System

The contract management system of CTMS maintains records of all contracts related to the study, stakeholders, and participants. In addition, the deviations, changes, and termination of the contracts are also maintained with controlled access. The contract management system also ensures the contract’s implementation during the study. The contract management system ensures responsibility for data privacy and safety.

Report Generation System

The report generation system of CTMS is an effective tool for capturing data and presenting it in standard formats. The report generation system effectively communicates the progress of the subject information, medical examination, analysis, eCRF, deviation in the study, stakeholder comments, and auditing reports.

Access Management System/Email and Push Notification

The access management system of CTMS ensures controlled access to manage the study. The controlled access ensures data safety, privacy, and traceability. Furthermore, controlled access ensures that the task specifications are met. In addition, email and push notifications ensure real-time communication and timely reminders of completing the task. The access management provides a specific sign ID and email ID with controlled access.

DISCUSSION

Data and information are critical parts of clinical studies, and the success of a clinical trial depends very much on successful data and information management.^23,24) Multiple CTMSs are available in Taiwan. However, few are synchronized or integrated with clinical research centers, hospital information systems, and sponsored data management systems. Our CTMS integrates CRC, IRB, BB, DSMS, Human Research Audit System, and ERPs of hospitals/medical universities.

Our CTMS has been established with dedicated architecture/design, data management, process management, and access management systems (Table 1). Its integration with hospital and CRC systems ensures improved clinical trial efficiency, data security, and privacy while enabling comprehensive process management and real-time monitoring. Compared with commercial systems, it is more cost-effective, customizable, and better suited to hospital management needs, offering timely updates and responsive maintenance. The independent data collection and storage in CTMS strengthens the safety of data privacy and real-time monitoring of eligibility, AE, serious adverse events (SAE), and clinical processes. In addition, integrated CTMS enhances efficiency in clinical trials by enabling real-time management, ensuring reliable results, and improving data quality through tools for sharing, tracking, and adherence to guidelines. Data privacy and information protection are crucial in system design to reduce the risk of data breaches.^23,25) Our CTMS provides essential tools such as restricted access and authentication permission to ensure data safety, protection, and compliance with Taiwanese GCP and ICH standards.

Table 1. Functional Requirements for Clinical Trial Workflow for Development of CTMS

No.	Requirement class	Requirement description
1.	Study project approval management	•  Multiple access •  Process optimization and automation •  Remote submission of project application •  Uploading of project materials •  Online submission of IRB •  Auto-generation of the task •  Uploading of required documents, including project proposal/materials, material annotation, remote submission of project application •  Real-time communication and messaging facility •  Access to documents such as ethical form, project title, Principal Investigator, trial period, and Pharma or CRO information to the institutional review board •  The data integration and importation from HIS, IRB, and JCRC •  Online approval system for study protocol and application •  Online movement of applications from one level to the next level •  Material annotation Regulatory Compliance and Data Safety •  Data privacy •  Data safety •  Traceability •  Structured development •  Review and approval by eSignature in CTMS •  Final signed off documents upload in eTMF •  Approval for protocol amendments
2.	Financial and budget management system	•  Proper budget planning and tracking •  Identification of billing activities •  Fund allocation for specific protocols, diagnostic, lab, and pathological tests •  The internal budget for protocol review, specific services, and tests conducted •  The billing for daily routine and non-routine daily care. •  Controlled access to track fund requirements, source of funds, and expenses •  Tools to access the billing status. •  Budget allocation for recruitment, training, and maintaining the staff. •  Billing of essential activities such as patient visits, completing accurate source documents and case report forms, maintaining regulatory documents, and communicating with the sponsor and contract research organization •  Automatic direct settlement between the hospital and the sponsor •  Payment and allocation management for payment addition, allocation (such as subject fee, investigator fee, and inspection fee), and review •  Workload statistics to generate financial statement
3.	Subject management system	•  Recruitment methods •  Data related to registries such as patient demographics, diagnosis, disease, product administered, and treatment details •  The data organization to fulfill the study’s specific requirements/information •  Integration of patient-related information in the subject management system with JCRC and ERP of three affiliated hospitals •  Visit record •  Specific features like study participant assignment (to assign investigators, nurses, clinical research associates, and coordinators and allow respective permissions) •  Protocol designs (automation of study plan, mapping of protocol with executable events), rule developments (for inclusion/exclusion criteria, drug randomization, number generation) •  List of running projects with access management, •  Subject list (with coded pattern to monitor the status/progress) •  Tracking of subject recruitment •  Subject study process management to manage the entire process including subject recruitment, visit information, study contents for screening, randomization, inspection, investigational products •  Absences, bank account details, data privacy consent, audit trail and interaction journal, DMS: medical findings and correspondence •  Ability to manage subject information automatically interface with HIS •  Ability to manage the subject’s schedule is automatically displayed in calendar form through the patient management function •  Ability to manage the quality control of subject includes informed consent, adverse event, protocol deviation, and inclusion or exclusion criteria managing for each subject •  Ability to manage the registration of healthy volunteer recruitment announcements and healthy volunteer pool management
4.	Contract management system	•  Contract negotiation for budget, recruitment criteria, resources, process, protocols, barriers, and management •  Quintessential feature of negotiating, monitoring, and fulfilling the requirement of the contract. •  Provides tools to address, discuss, and document other issues related to patent protection, study data, confidentiality, indemnification, subject injury, publication, and intellectual property rights
5.	Report generation system	•  Report to communicate the requirements, progress, and challenges to stakeholders •  Electronic trial master file (eTMF) is an electronic document management system that provides storage and access to all necessary TMF Case report form (CRF) designing and CRF annotation •  The electronic storage of study documents such as protocols, investigational product brochures, safety measures, informed consent forms, and regulatory documents
6.	Permission and business management system	•  Controlled access to the stakeholders and participants •  Integration of controlled access with JCRC and hospitals’ ERPs •  Single Sign-on System (SSO)
7.	Email and push notification	•  To ensure the quality of the study •  To maintain records of communication for the future •  The push notification for to-do and email is integrated •  Avoid any omission of tasks and messages due to human error
8.	Integration of CTMS	Integration with •  JCRC •  JIRB •  Human Research Audit System •  Joint Biobank Management System •  Biological Sample Management System •  Accounting information •  SMTP services •  SSO •  DSMS •  ERPs •  Data sync with patient amount and study information

CTMS: clinical trial management system, eTMF: Electronic trial master file, JCRC: Joint Clinical Research Center, JIRB: Joint Institutional Review Board, JBB: Joint Biobank, DSMS: Data Safety Managing Section, SMTP: Simple Mail Transfer Protocol, SSO; Single Sign-on System, ERP: Enterprise Resource Planning.

In addition, e-CRFs offer an electronic alternative to traditional paper CRFs, though source data verification (SDV) remains essential for accuracy. Our CTMS streamlines this process by automating structured data collection from CRC, ERPs of hospitals/medical university, removing the need for SDV and maintaining audit trails to track changes. Future developments aim to incorporate natural language analysis for unstructured data and integrate electronic data capture (EDC) with hospital e-CRFs for efficient and secure clinical data transfer.

Integrating the CTMS with other hospital and CRC data systems allows collaboration on a shared platform, expanding patient resources and optimizing clinical trials through intelligent recruitment and efficient subject matching. This accelerates trial timelines, lowers research and development costs, improves market competitiveness, and offers valuable insights into disease trends, risk factors, and treatment outcomes, enhancing clinical research and personalized care. These insights also support health authorities in making data-driven decisions for effective health management. The future of clinical trial monitoring is shifting from on-site to centralized monitoring. Remote monitoring improves research quality and efficiency while lowering costs, thanks to the widespread adoption of electronic tools such as CTMS, EDC, EMR, and clinical data management systems.²⁶⁾ Our hospital’s CTMS unifies multiple teams on a single platform, seamlessly connecting with all clinical systems. Built on an Internet-based framework, it facilitates remote data monitoring and cloud-based auditing, all within a well-established operational structure.

Notably, CTMSs stand out from other information systems due to their specialized and tailored nature. While system design is essential, the comprehensive and efficient use of the system takes longer to implement. As clinical research becomes increasingly digital, integrating and sharing research data offer several management advantages, such as improved access to resources, data-driven decision-making support, easier remote management, enhanced accuracy, and better pre-operational capabilities. The CTMS developed by our hospital will undergo continuous updates, with its functionality continually improving. These updates will ensure alignment with global advancements in clinical trial management, promoting more standardized practices and strengthening the hospital’s position in high-level clinical research. Apart from various positive outcomes, our study also includes some limitations, such as the unavailability of full-year data for 2024, which is why most parameters decreased from 2023 to 2024.

CONCLUSION

Our first integrated CTMS developed independently, is tailored to meet institutional needs for a comprehensive, dynamic evaluation and supervision of clinical trials. The CTMS features a unified interface with multiple access methods, enabling seamless data integration with clinical systems. It supports comprehensive data management across all trial stages, from project approval to operational oversight, while ensuring data security and subject privacy through robust security measures and privacy protection protocols. The increasing number of trials, subjects enrolled, products developed, investigators, new drugs and indications, devices, and new medical technology indicates its robustness and efficacy. However, managing and customizing CTMS according to the latest requirements and changing standard guidelines for achieving higher efficacy is recommended.

Conflict of Interest

The authors declare no conflict of interest.

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