Clinical Trial Management Software

The ever-changing drug development landscape and the public health crisis due to the outbreak of pandemics exert a significant amount of pressure on medical research institutes to effectively and quickly conduct clinical trials to evaluate a medical intervention systematically. Software like CTMS or Clinical Trial Management Software are making big strides in enhancing the process of clinical trials by replacing time-consuming manual approach with automation and intelligent data-processing techniques. CTMS software helps clinical scientists identify the system's bottlenecks and reduce the clinical trials’ overall redundancy rate.

The CTMS solution can accelerate many activities associated with clinical trials, including; patient recruitment, assessing site performance, task scheduling, generating analytics reports, tracking global trials running in multiple countries, etc.  It provides a plethora of benefits to clinical trial work, and to take maximum advantage of the software; the users should select the right CTMS software that suits best to their research work and organization goal. This buyer’s guide to Clinical trial management software documents some key points of the clinical trial management software that Clinical Scientists, Clinical Research Organizations (CROs), and Medical Research Institutes should consider before buying the best CTMS software.

Clinical trials deal with the medicines or therapy that directly deals with the individual’s life.  It is necessary that all their trials are well documented, with end-to-end transparency throughout all facets of the process like patient’s data, compliances, protocols, financing, etc.  Without efficient clinical trial management, the researchers can miss vital information, and it can risk the patient's life.  Besides that, there are many people involved in the clinical trial, like a chief investigating officer, trial manager, a data manager, a trial programmer, data clerks, and other trial-specific staff. Each of these professionals has a significant role in the clinical trial, and they should be clear about their roles and involvement in the trial. A well managed clinical trial can address their exact roles and work as a team for a common goal.

Another critical aspect of a successful clinical trial is data management.  Well-managed data can help researchers and institutes conduct the trial efficiently and reduce the errors due to manual data entry.  Team members of clinical data management have a major role to play throughout the entire process of a clinical trial.  Various activities they perform throughout the process include database designing, data-entry, data validation, Case Report Form (CRF) designing, CRF annotation, data extraction, discrepancy management, medical coding, and database locking. Clinical data management aims to feed quality data to the clinical trial process to prove or disprove the drug trials.

• Ineffective coordination:  In the traditional approach, communication is dispersed around various departments, due to which the team cannot coordinate effectively.  The approvals of protocols and equipment can take more time, and each department has different approval guidelines and procedures. Due to inefficient coordination among the team, the clinical trial process becomes complicated and lengthy.
• Data collection: Data collection with the traditional approach is a humongous task; it involves lots of manual entry and is prone to errors. The data recited in various places and in multiple formats; it becomes challenging to aggregate them all manually. Maintaining the data quality is a different set of challenges that the researchers face with the legacy system.      
• Patient recruitment:  It is one of the critical challenges that always remained in clinical trials. Clinical trials involve recruiting people or patients from various ethnic backgrounds, races, ages, physiques, medical conditions, men, women, geographic regions, etc. Recruiting and boarding candidates for clinical trials is time-consuming when done manually. 
• Higher expense:  The traditional approach involves a lot of manual work, due to which the overall cost for conducting clinical trials can go higher.  Also, without an expense tracking system, it is difficult for an investigating officer to identify the area that consumes more expenses.
• Low adaptability: The legacy system cannot keep pace with modern drug trial methods. Sometimes the drug trials need to fast-track their process due to the urgent need for drugs or to curb the surge of infectious disease; the legacy system is not flexible enough to adapt the new drug trial methods or procedures.
• Data security: Data security is a key concern for Clinical Research Organizations(CROs) and Research Institutes conducting clinical trials with the legacy system. Following a weak security protocol for data transfer always leaves data vulnerable.

These are some common pitfalls of the traditional clinical trial approach, which gets critical as the trial progresses for a more complex study.  For trouble-shooting these issues and streamline their projects, the research institutes and clinical trial scientists have underpinned CTMS or clinical trial management software in their studies. There are huge benefits of a clinical trial management system that traditional clinical trial methods fail to deliver.

Clinical trial management software is a tool used by medical research institutes, pharmaceutical, and biotech companies to plan, manage, and track activities related to clinical trials. It assists the research team in various ways to efficiently conduct clinical trials from start to end.  Clinical trial management software helps manage various activities related to clinical trials like patient recruitment, site selection and monitoring, financial management, contact management, and regulatory document tracking.

The clinical trial management software are used for operating following activities during clinical trials study,

• Project management
• Patient recruitment
• Compliances
• Financial management
• Operational Reporting
• Subject visit management

CTMS also envelops the clinical trial data management software efficiency and helps in data validation.  Though it is not necessary that all CTMS have covered the trial data management software functionalities, however, most of them do.

• Clinical Research Organisation (CRO)
• Medical research institutes
• Pharmaceutical and Biotech companies
• Sponsors of a clinical trial
• Research hospitals
• Academic medical centers

• EDC: EDC or electronic data capture is a software used to collect, clean, transfer, and process data in clinical trials. A few years back EDC replaced paper-based clinical trial systems. Most EDC systems nowadays are cloud-based. 

• Clinical trial management software: Clinical trial management software is used for managing the whole clinical trial process. Clinical trial management software does not involve data collection. Instead, it emphasizes the operation management related to the clinical trial. The modern clinical trial consists of both EDC and CTMS. In short, for an effective clinical trial, both EDC and CTMS are required.

• Reduce complexity:  The modern clinical trial software are clubbed with clinical data management software capabilities and advanced technology like automation, which makes the clinical trial simple and effortless.  It allows researchers to manage everything from a single platform.
• Managing budget and increase revenue: The best CTMS solutions come with the features to gain full visibility over the procedure cost.  Besides that, it even assists in tracking invoices and payments from sponsors.  It improves cash flow and increases revenue.
• Manage time spent on protocols: Identifying the time-processing tasks that are directly affecting the study-related tasks is essential. The CTMS software gives the ability to view the time requirements of each protocol and recognize the underlying inefficiency.
• Control excess spending:  The CTMS solutions keep a thorough account of the resources, including inventory used during the trials, and keep track of the shipment.  It helps them to get a complete overview of the available resources and prevent the excess ordering of the merchandise.
• Minimizing protocol deviations:  With all the protocol information aggregated in one place, it becomes easy to ensure that all the research studies are on track and performed adequately. 
• Improves site’s negotiating power:  The CTM software can help clinical trial companies to estimate the protocol cost more accurately and give them the power to negotiate better with the sponsor.

• Contact management
• Document Management and eTMF
• Plan project milestones and tasks
• Contract and payment system
• EDC integration
• Track recruitment and compliance metrics
• Resource management
• Track communication
• Scheduling patient visits
• Store patient current and historical data
• Real-time status tracking
• On-site audits and workflow management
• Tracking sponsor payment
• Audit trail
• Query management
• Automatic reminders
• Mobile apps
• Risk monitoring
• Support eTMF ( Electronic Trial Master File)
• Data source verification
• Planning and tracking clinical training
• Support for a randomized trial

• Faster clinical trials:  The clinical trial management system with the centralized database and trial protocols makes the workflow simple.
• Access to accurate information:  The CTMS solutions allow communicating effectively with the staff and updating the tasks in real-time. 
• Reduce data redundancy:  The modern-day CTMS software reduces the data redundancy as it enables to import data directly into the clinical trial management system.
• Better analytics and reporting capabilities:  In-depth data analytics gives users clear insights into their study and issues around the trials.  The software can populate reports for one study or a holistic view of multiple studies.  Some CTMS even give options to create customized forms, reports, and exports within the system.
• Minimizes study cost: CTMS can be helpful in controlling the cost of clinical trials by letting the investigating officer decide whether a particular study is financially viable or not. It can also reduce the cost of recruiting patients through third-party recruitment with the inbuilt patient registries.
• Increase productivity:  The CTMS can track and manage the clinical trial study, which makes it easier for the investigating officer to find out the issues with the study development, protocols, administrative work, etc.
• Trial site management: The software facilitates the investigating officer with site identification and tracks enrolment metrics for each study.
• Project/Study management:  The best CTMS software can assist in CRF and protocol management to capture data across workflow with user account policies, authentication checks, and access control rules.
• Lower trial costs: Before the clinical trial management system was introduced, the clinical trial was conducted using multiple disparate systems, which were costly due to the non-standardized process. The CTMS software has helped research institutes to streamline the clinical trial process and reduce the overall trial costs. 
• Email alerts and notification:  The email alerts and notification has a critical role in clinical studies.  The CTMS with alerts and notifications informs clinical scientists about the latest progress in the research as well as if a particular document needs special attention from the researchers.

• Software Costs:  The price of a clinical trial is crucial, especially if the Clinical Research Organisation (CRO) or Research Institute is on a start-up level.  There are many factors that may vary the price of the software, like extra fees for additional studies, additional features, and software renewal charges.
• User-friendly interface: CTMS with a user-friendly interface and capable of handling complex studies can have more adoption rate than with complex UI. The team can save time and cost that they invest in training or hiring the expert to train the staff.
• Rich features list: The top clinical trial management software solutions are packed with time-saving features. The users will have to verify whether the clinical trials software cover the features that fulfill the research specific requirements. Importance also to be given to check whether the software offers the complete package; right from the facility to generate financial reports, to recruit the patients for the study, or to track the site communications and so on.       
• Regulatory Compliances: Clinical trial is a sensitive field and deals with the confidential data of patients.  So users must check that the software abides all the regulatory compliance mandatory for the CTMS.
• Customization option: The researchers who have tailored needs can search the clinical trial management software with the customization option.
• Integration with cloud services: The data of clinical trials have double folded in recent years. Some research institutes are finding cloud services as a better option to manage their data and IT infrastructure. The best CTMS software should sync easily with cloud services.
• Efficient in risk analysis: The clinical trial management software should have the ability to showcase the risks associated with the trial.  The dashboard of the software should reflect the pre-identified risks that could affect the quality of the study. 
• Scalable: The software should be scalable to meet the rising need of business.  It is not preferable for researchers to switch to other clinical trials software companies while in the middle of some critical research.
• Security: Controlled document access is essential for the security of the clinical trial document. The software should prevent unauthorized access and reduce the risk of data theft.    
• In-built communication and scheduling capabilities:  Efficient inter-communication can improve the team efficiency and keep the conversation restricted to the organization, whereas the scheduling capabilities within the clinical trial software can help to streamline the workflow.
• Efficient data management: The CTM software should be able to handle complex data sets and support all the functionalities that a clinical trial demands.

• Virtual monitoring of clinical trials: The virtual clinical trial is conducted using various mobile apps, video conferences, and remote monitoring devices.  In a virtual clinical trial, the patient visit does not happen like in the traditional settings, and most of the time, it is conducted in the home via telemedicine.  From taking patient consent to delivering medicines to the patient, everything happens online. The virtual clinical trial does not have any limit on patient limitation and can recruit globally; it has huge scope in the future.
• Wearables and ingestible sensors:  Wearable and sensors can change how clinical trials are performed today.  It would give more insights on the clinical study and provide an additional source of data. The ingestible sensors and wearable enable researchers to collect important data even from remote places, and more importantly, it can continuously feed real-time data. The real-time data is valuable for clinical trials as it improves clinical trial efficiency and lessens the risk on the patient. The future clinical management software would be integrated with the technology that supports wearable and ingestible sensors.
• Blockchain technology:  Though blockchain is surrounded by a lot of speculations and assumptions on its application in the real world, there is no doubt the technology is disruptive.  The decentralized mechanism and secure transactions have already impressed financial sectors, and the same spirit is anticipated by the health care sectors.  Medical researchers can use blockchain to recruit patients, store data securely, create contracts, and improve trial efficiency.
• Big data analytics:  Big data analytics gives clinical scientists the power of in-depth analysis and allows them to reach conclusions faster with a high accuracy level.  Big data analytics can accommodate data from diverse sources and allow users to visualize data from various perspectives.
• Patient-centric: Research institutes are adopting a patient-centric approach actively for an efficient clinical trial.  Patient recruitment takes a lot of time, and the research institutes are making efforts to ensure that the patient faces fewer invasive procedures or has a lower visit burden. The patient-centric approach makes the patient’s participation easier and accessible. In fact, the Clinical Research Organizations (CROs) having a rich database of patients can save time and cost on trials.

There are many factors that determine the price of clinical trial management software like clinical trial design, data-storage limit, protocol amendment, and myriads of other things. 

But besides regular CTMS features, there are few more considerations that could affect the cost of the CTMS, which are generally overlooked by the users. These include software setup costs, training costs, system validation costs (if applicable), recurring fees (license), APIs and data connector fees, etc.  The users can decide to use software either web-based (hosted), cloud-based, or on-premise (licensed enterprise) CTMS.

• CTMS for start-ups and small size CROs/Research Institutes:  The research institutes that are conducting clinical trials on a smaller scale or it is CRO (Clinical Research Organization) start-ups then software like SmartSheet with a starting price of $14/month is an ideal solution. The users can scale-up to an advanced version, which can cost users about $ 25/month. Another cost-effective tool that users can consider for the clinical trials is ABAdesk with a starting price of $10/month. Both these tools offer a 30-day free trial.

• CTMS for large and medium scale CROs/Research Institutes:  The research institute conducting clinical trials on a larger scale and having intricate research work can consider CTMS software like CREDIT. The software costs $13,500 and gives unlimited users access and storage.  It also offers some out of the box features like capturing protocol details or analyzing trial start-ups costs. The software is a complete package for conducting the clinical trials successfully.  The other popular CTMS tools that fit in the same framework and can handle all types of clinical trials include OnCore, Castor EDC, Arone, and Bioclinica. There are few more tools that can be helpful to users for managing their clinical trials like Clindata cloud, Catchtrial, and SureClinical.The users can choose the software based on their study requirements and ROI.

• Free and open source clinical management CTMS software:  Free and open source clinical management software gives users access to the source code so that they can not only use the software but also modify and distribute it to enhance its efficiency and reduce the cost.

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The outbreak of pandemics on a regular interval has made the global health care system vulnerable, and it leaves its footprint for many years, even after the remedies are discovered. The researchers and clinical scientists are redefining their strategies to eradicate pandemics in a timely manner and consider technology like clinical trial software as a game-changer. The clinical trial software can fast track the clinical trial process and help in reducing the drug delivery time.  The research organizations focused on performing clinical trials with high-accuracy and reducing their study time should not miss the list of best clinical trial management software.