Clinical Trial Management System Software

Clinical Trial Management System, or CTMS, is a software application that manages the operations, workflows, and data in clinical trials or research. A custom-built CTMS tends to centralize all data, standardize workflows, and keep track of participants and other entities involved in clinical studies or trials. OSP is proficient in developing a customized clinical trial management system with these capabilities. We can design a CTMS system to efficiently find and manage participants, plan and track trial projects, and analyze clinical trial information. We can ensure that clinical trial management software is a HIPPA-compliant solution. OSP can develop this CTMS software to cater to the specific needs of pharmaceuticals, CROs, research centers, and sponsors.   

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Explore Clinical Trial Management Software

Several clinical investigators and researchers face a common challenge: EHR data and EDC data need to be collected together. Since both these data are crucial for analysis, the connectivity between EHR and EDC is essential. OSP can leverage healthcare automation technology to connect EHR and EDC systems. We can ensure that data from the sources are collected at one centralized location within clinical trial systems.    

Further, we assure you that this centralized collection of EHR and EDC will ensure all clinical data standards. This will ensure the data can be used and shared for medical purposes. As we facilitate this connection between EHR and EDC, the clinical trials management software users can gain complete access to patients’ information. This will also help them to streamline and simplify clinical trial operations in real-time.

Clinical trials or studies must strictly follow compliance and patient data safety protocols. CRO and clinical trial organizing companies need to monitor this regularly. We can develop a clinical trial management solution to help these CROs effectively track protocol compliance. OSP can ensure that custom clinical trial management systems will automatically monitor the security of participant data and clinical study results.    

We can also enable the clinical trial monitoring system to send alerts in case of potential security risks. This will help users to address and mitigate them. At OSP, we understand that clinical trials can impact participants’ health. So, we ensure that the CTMS system can alarm researchers or investigators if any critical health condition is detected. This will safeguard participants’ health and help researchers keep complete track of the trial. 

Clinical trial management software integration with clinical research websites is essential to ensure seamless processes. Clinical trial investigators or sponsors have separate websites, and integrating the CTMS can display all information related to ongoing and upcoming clinical studies. OSP can facilitate this integration using a simple interface, making it easier for CTMS users to add or remove clinical studies as required.    

Moreover, we can ensure that the integration will help users create clinical trial-specific pages on the website. This integration will also enable users to share information on other sites to promote and attract participants for clinical studies. We assure you that website integration will create a more streamlined path for clinical trial subjects to locate and apply for it. Through this integration, OSP can empower CTMS users to check the new subjects’ applications on the clinical trial management system. 

Clinical trials usually take months or even years to complete. The researchers must conduct the trials according to various criteria and note each result carefully. OSP can build software for clinical trials with tools for comprehensive reporting and analysis. We can use advanced analytics within clinical trial software solutions to process enormous amounts of trial data. This feature can help investigators and researchers with insights that can improve the quality of research.    

Besides, we can create intuitive dashboards to present different aspects of trial data. This trial data includes status, potential risks, and other metrics in a unified manner. These reporting dashboards can help users with analytical information to assess the effectiveness of ongoing and future trials. Above all, we assure you that including analytics and reporting within CTMS systems for clinical trials can also improve overall care management, including patient care.   

Clinical trials are highly regulated and would require lots of documentation. All trial documents are important not only for trials but also for legal purposes. OSP can build software for clinical trial management with a secure document management feature. A CTMS solution also needs document management capability, like a medical records management system. We can make sure all relevant documents are stored in one place. This will allow users to access and share them with clinicians, nurses, or other investigators when required.    

Moreover, we can not only include document management but also eTMF. That means we can centralize document management, including authoring and approving documents. Also, we can facilitate automatic publishing to the eTMF. Above all, we assure you that including document management in clinical trial management solutions will effectively streamline the execution and commercialization of clinical trials all across. 

In the clinical trial management system, recruitment management is crucial, as it helps identify and select eligible patients for studies. OSP can help CROs and investigators find eligible participants through a custom-building CTMS system. We can leverage cutting-edge technology to help researchers identify and track down suitable patients for clinical trials. This feature can save researchers and investigators a lot of time and effort.    

Besides, by including this feature, we can also guarantee high accuracy and quality of the clinical trial. As we can digitize the entire recruitment process, we can also include some smart features. These can be a minimal dependency of participants on investigators/researchers, automatic roll-ups, better metrics, and enhanced analytical capabilities.   

The payment processing system is also an essential clinical research management system feature. This feature helps researchers and CROs track tasks, form receipts, and facilitate payments. We can engineer CTMS software with this feature that will automate all these tasks. We can enable researchers to generate payments, create comprehensive invoices, view payment history, and manage the clinical trial budget.    

We can guarantee that with this feature, researchers and CROs can focus more on clinical study and site. Further, we can simplify the accounting practices by keeping track of advance payments to sites, partial payments, unscheduled and invoiceable items, and payments held back. Above all, we can develop CTMS with this feature to suit your financial needs. We can enable researchers to set payment frequencies as per their business needs, as it will keep everything on track.   


In clinical research software, ensuring data management is a must. OSP can develop clinical research management systems that can efficiently manage and track all data. Due to efficient data management, CROs and sponsors can gain a wealth of information. Moreover, CTMS can also ensure a reduction in inaccuracies and missing details. Also, our custom-built CTMS solution will improve transparency for researchers.

OSP's custom-built clinical trial software can offer stronger security. Since clinical trial data is more prone to cyberattacks and privacy threats, ensuring clinical data security is a foremost task. We guarantee that our tailored CTMS will include multi-factor authentication, strong passwords, encryption, and more. Such security measures will benefit CROs, sponsors, and providers. And stronger security means cost savings, too.

Patients' multiple enrolments can affect clinical trial research and its results majorly. However, OSP can design and develop clinical trial database software to complete track of enrolled patients. We can use biometric technologies to detect patients participating in ongoing trials and prevent further enrolment. This will benefit CROs and sponsors by saving their money and time. Also, it will save a lot of effort and patients' lives.

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Clinical Trials Management Software Services


Streamline Clinical Trials Workflow Process 

  • Custom-build a comprehensive and scalable CTMS solution
  • Facilitate necessary integration with EHRs and wearable devices
  • Standardize clinical trial workflows to improve operational efficiency
  • Offer real-time visibility of clinical trial data to researchers
  • Highlight potential risks and issues at different levels of the study

Support end-to-end trial management

  • Facilitate end-to-end trial management capabilities 
  • Oversee investigator database and ensure seamless integration with analytics
  • Identify potential risks by increasing data quality and improving visibility
  • Manage investigator sites, payments, documents, and on-site monitoring 
  • Ensure full compliance with security protocols and standards

Modernization of legacy CTMS software

  • Leverage transition to new clinical trial management systems
  • Optimize the workflows as per new CTMS systems 
  • Enable customizations of new CTMS software
  • Facilitate the transition of old legacy software to a cloud-based system
  • Offer continuous tech support and comprehensive training before going live

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Frequently Asked Questions

Clinical Trial Management System is a comprehensive software application that facilitates the entire lifecycle of clinical trials. Its key components include a central repository, trial planning, regulatory tracking, team and supplier management, financial tools, reporting, and system integration. These components synergize to centralize communication, enhance collaboration among research teams, and optimize the management of clinical trials from inception to completion, covering aspects like study setup, enrollment, monitoring, compliance, and reporting.  

CTMS software streamlines patient data management, encompassing enrollment, demographics, and medical history. It centralizes this information, ensuring access to up-to-date and clear data while identifying anomalies. The trial management system acts as a unified, web-based platform for overseeing clinical research, offering various functions such as study startup, regulatory approval tracking, document accessibility, subject activity monitoring, and financial management. Its role in centralizing communication enhances team collaboration and optimizes clinical trial operations, including billing compliance and sponsor invoicing.  

In safeguarding sensitive patient data, a CTMS system for clinical trials must adhere to crucial security and compliance measures. This entails implementing stringent data governance and access rules, excluding personal health identifiers. It also includes complying with HIPAA, GCP, GDPR, and 21 CFR Part 11 regulations. If serving as a system of record, the clinical trial monitoring services should be validated with appropriate controls. Additionally, robust help desk support and secure data collection, storage, and retrieval mechanisms are essential to prevent unauthorized access and ensure data protection.   

Clinical study management software streamlines subject randomization and allocation in clinical trials. It employs chance-based methods to assign participants to treatment or control groups, reducing bias. Common randomization techniques include simple, restrictive, adaptive, and stratified randomization. The CTMS software may also use patient randomization and supply management (RTSM) to ensure blinded and unbiased treatment allocation. This enhances trial efficiency, minimizes bias, and supports rigorous statistical evaluation, making clinical trials more robust and reliable.  

Clinical trial systems ensure compliance with regulatory requirements for adverse events and safety data reporting by centralizing data tracking and management. It facilitates accurate adverse event reporting and electronic regulatory document management. CTMS also serves as a centralized repository for clinical trial data, including safety data, adhering to regulations like GCP, FDA, and EMA. This comprehensive approach enhances data accuracy, streamlines reporting, and promotes regulatory compliance in clinical trials.  

Software for clinical trial management facilitates effective management of clinical trial budgets, financial tracking, and resource allocation through centralized data management. It tracks study budgets, expenses, and payments while offering real-time financial reporting and analytics for informed resource allocation decisions. The CTMS solution ensures compliance with financial regulations like the Sunshine Act and provides precise invoicing and payment tracking. Leveraging a CTMS streamlines financial management, enhancing efficiency, compliance, and the financial health of clinical trials.

Preserving data integrity is crucial when transitioning from a legacy clinical trial management system to a newer system. Considerations include: 

  • Auditing existing data. 
  • Creating a migration plan. 
  • Building data backups. 
  • Validating data pre-migration. 
  • Ensuring ongoing integrity checks. 
  • Conducting post-migration validation. 

The goal is to minimize workflow disruption and ensure the accurate and complete transfer of data, safeguarding the reliability of clinical trial information during the transition.   

Data privacy regulations such as GDPR and HIPAA hold great significance in CTMS. These regulations impact how patient data is stored and handled, emphasizing the need for security, confidentiality, and compliance. CTMS must adhere to strict data governance, access control, and the exclusion of personal health identifiers to protect patient privacy. Compliance ensures that sensitive data is securely collected, stored, and accessed, aligning with the stringent requirements of GDPR and HIPAA.

Several measures can be adopted to enhance data quality and minimize data entry errors within clinical trial management systems, particularly with multiple users. These include establishing consistent data management standards, providing training and SOPs, implementing data monitoring and quality assurance protocols, using electronic case report forms, integrating with EDC systems, and employing quality control measures like double data entry. These steps collectively bolster data accuracy and integrity throughout the clinical trial process.  

Risk management in a CTMS solution involves identifying, assessing, and mitigating threats to a clinical trial’s success. It necessitates a well-documented plan, personnel training, and data monitoring to ensure data accuracy and patient safety. Risks are identified and prioritized based on their likelihood, impact, and detectability. Technology plays a crucial role in driving risk management processes, and mitigation is achieved through tailored monitoring plans following a risk-based approach, ensuring smoother and more successful clinical trial outcomes. 

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