The process of conducting clinical trials on drugs is a very complex and challenging task.To simplify this procedure and approach this challenge in a more systematic manner software like Clinical Trial Management Systems.

Introduction

Clinical trial management system AKA CTMS bring together Researchers, Co-Ordinators, Stakeholders together on one platform to plan, track, manage clinical trial activities on drugs. Some features include participant enrollment, tracking, study document management, daily study visits, monitoring progress, data collection, data analysis, compliance management, financials etc. All these features come on one single platform. No need of paper work or manual systems, hence reducing the human clerical error to a very huge extent.

Benefits of CTMS

Enhanced Efficiency and Productivity

Like the heading says Efficiency, productivity are one of the key benefits of CTMS. Activities like manual and repetitive tasks like data entry, document and participant tracking are automated, allowing researchers and study co-coordinators to focus on other critical activities.

Improved Data Accuracy and Integrity

Data accuracy is pivotal in all Clinical trials. CTMS achieves this by data entry forms standardized across the entire clinical trial. Data validation, real time monitoring are other added benefits. Hence again reducing errors and inconsistencies and getting more trustworthy results.

Regulatory Compliance

Regulatory compliance is very complex and tedious making the entire process prone. With a CTMS in place, all the compliance are already keyed in and ready in the system. With simple easy to use features like drag and drop, selecting a process gives the users a predefined approach, hence reducing the compliance violation cases and avoiding penalties

Some Key features of Clinical Trial Management System

Participant Enrollment and Tracking

This features screens participant eligibility, tracks participant visits and interventions. Also users are prompted for electronic informed consent which is again an automated process, further simplifying the operations of participant management.

Study Document Management

Document management is critical as procedures for Study protocol, consent forms for participants, case reports and other regulatory documents are to be managed in a structured manner. Electronic documents are then stored securely for later sharing, organizing, easy access and version control.

Monitoring and Reporting

Monitoring and reporting in a CTMS covers

• Real time study status updates
• Data monitoring
• Data verification
• Generating Simple and Comprehensive or custom reports.

Aiding researchers to quickly identify any any discrepancies and immediately action on it

Financial Management

Some financial modules covered are Budget allocation i.e. Example payment, invoicing for participant trials to be captured in the system which can then be integrated with the financial system.

This integrates facilitates tracking of expenses, financial reports generation.Ensuring transparency, accuracy and giving visibility to track costs of the project and prioritize budgets.

How a Clinical Trial Management System can improve efficiency

Clinical trials are complex and expensive to manage and execute. But with CTMS, these all can be streamlined read on to check the various aspects.

Streamlining of Participant Management:

• Eligibility screening
• Randomization Screening
• Participant visit tracking
• Interventions (When required)

can be automated with CTMS saving time, resources and reduces the risk of errors

Automated Data Collection & Analysis

Data collections can be automated by

• Providing standardized data entry form
• Data validation
• Built In Data analysis tools of accumulated data.

This allows to analyze and interpret more easily

Efficient Document Management

A CTMS is all about documentation, a good CTMS Simplifies documentationCentralized Platform to store, organize and share documentsProvides Version control, collaboration among teamsProvides quick document retrieval reducing administrative burden

Real-time Monitoring and Reporting

• Real time monitoring with reporting capabilities
• Facility to update the studies and provide stats updates
• Create and execute simple, comprehensive and custom reports

The above features allows for quick problem identification.

Choosing the right Clinical Trial Management System for your organization

Here are some key factors to consider when selecting a CTMS:

Identify Your Organization’s Needs

Some immediate factors are

• Complexity of Clinical Trials
• Size of the trial
• Numbers of users
• Any specific functionality towards the trials.

Evaluate User-Friendliness and Accessibility

A CTMS is only as good as how user friendly and ease of use is..

• Easy Navigation
• Intuitive interface
• Custom Workflows
• Easily accessible from different devices (Ideal for employees who are working from home)

Consider Integration Capabilities

This is cruicial as when CTMS has to handshake with existing systems in the organization like Electronic Data Capture Systems, Electronic Health Records etc Data should be able to seamlessly flow between both the organization servers/infrastructure and CTMS servers/infrastructure.

Evaluate Data Security and Compliance

Clinical trials consist of sensitive participant or patient information. Checks for data security standards, access controls & encryption during transition, check for regulatory compliance too, some of them are managing regulatory documents, conducting audit on the trials.

Implementing a Clinical Trial Management System in your organization

Define Your Implementation Strategy

Some check below are

• Team Size
• Setting Clear Goals and objectives
• Timeline for implementation completion

The more the detailing the better the transition

Customize the CTMS to Your Organization’s Needs

• Custom workflows
• Creating custom data points (Data entry forms)
• Integration with CTMS

With these points we can maximize on the benefits

Provide Training and Support to Users

• Training of using the platform
• Successful adoption with proper knowledge transfer
• Post implementation support

These check points will instill comfort and confidence during this transition to a new CTMS

Monitor and Evaluate the Implementation

• Evaluate the effectiveness during during equal intervals. (Which can be achieved through consistent monitoring)
• Encourage user feedback
• Rate user satisfaction
• Revised training on new modules that are updated.

Best practices for using a Clinical Trial Management Software

• Work on consistency and efficiency by standardizing workflow and processes.
• Define protocols rights from participant enrollment to document version updates
• Update the Clinical Trial Management Software to the latest versions by updating the latest security patches etc
• Cleaning of outdated or duplicate information across all departments
• Encourage teamwork by fostering collaboration among fellow researchers.
• Ensure every one in the team is updated with the latest update in the clinical trial process
• Train and educate users on how to use CTMS with regular training, sharing the latest features and functionalities, advise the best practices etc

The future of Clinical Trial Management Systems

• CTMS to integrate with Electronic Health Records are becoming a necessity
• Integration for seamless data exchange and real time access to participant or patient information.
• Adoption of Artificial Intelligence and Machine Learning in to the CTMS Modules to help identify and automate repetitive tasks
• With Artificial Intelligence and Machine Learning we can identify patterns and trends in large datasets allowing researchers to take data driven decisions.
• CTMS should be Mobile friendly
• Encryption to protect from intruders Patient Sensitive data.
• Adherence to privacy regulations like GDPR

Top Clinical Trial Management System software providers

Some top companies that we can recommend are

• Clinevo Technologies
• Medidata Solutions
• Oracle Health Sciences
• BioClinica
• Veeva Systems

Clinical Trial Management System (CTMS) plays a crucial role in improving the efficiency and effectiveness of clinical trials.

Electronic Trial Master File (eTMF) solutions are quickly becoming an essential option for managing clinical trial documentation. This helps in replacing paper trial master files and clunky file shares. Earlier, organizations used to face a lot of challenges that come from managing trial master file content on paper or in file share systems. The effort required to locate, manage and collaborate on important documents in a timely manner has caused many organizations to search for more efficient solutions

eTMF systems are gaining widespread acceptance, however, many organizations that seek this solution are still not completely familiar with the core features of an eTMF. In the following article, you will get to know some of the most powerful features found in an eTMF software that clinical organizations should be looking for.

Below are the features you should essentially look for while searching the perfect eTMF system for your organization:

1. Prebuilt DIA TMF Reference Model & Configurable Organization / Sponsor Specific TMF Reference models:

The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. DIA is the reference model for TMF which is widely used and accepted by most of the global companies and regulators. The eTMF system should come with a prebuilt DIA reference model hierarchy and the system should automatically create the structures for Study, Country, and Site level documents.

Although the DIA reference model is important, it is equally important that the system should allow organizations to define their own TMF structures and sponsor specific organization folders. The system should support customizing the existing DIA TMF model or configuring Organization / Sponsor specific TMF structures.

2. File Planning & Milestones Setup for Study, Countries and Sites:

The system should allow companies to setup milestones at the study level, country level, and site level and plan on what documents and how many numbers of mandatory and optional documents that are targeted to be collected.

Once a file plan and milestones plan are setup for a study, the system should be capable of tracking the clinical trial document in accordance to the plan and alert users if some of the sites are not meeting the plan and milestone due dates

This is one of the mandatory features for an eTMF system. Without this feature the system becomes a simple File sharing platform.

3. Live Tracking of Missing Documents & Document Statues:

Based on the file plan setup for a Study, Country and Site, the system should highlight the status of the document along with missing documents to monitor the TMF compliance at every level.

4. Bulk Upload / Quick Upload & Flexible File Indexing:

The system should allow users to upload documents in bulk where in hundreds of documents can be dragged and drop in one go. This feature will be very useful when there is a remote site that can not place the documents in the right TMF hierarchy. Such remote sites can upload all the documents into a TEMP directory into the system and later the central coordinator/CTA or CRA can index the documents to the right TMF structure.

5. Automated Version Controlling:

The system should be capable of tracking each version of the document along with its description of changes every time a document is modified/ re-uploaded.

The system should be capable of having automated versioning based on the user edits and at the same time system should ensure only one user can modify the document at a given point in time to make sure every version of the document contains who has done what changes.

6. Electronic Signatures & Converting to PDF:

The system should be capable of capturing the electronic signatures of the authors, reviewers and approvers and print the same when it’s downloaded as PDF with inbuilt PDF conversion options. System should also be capable of printing configurable watermarks and the change descriptions along with electronic signatures.

If you want to have a 100% electronic TMF, then the signature technology also needs to meet the requirements of 21 CFR Part 11 electronic signatures when signing records.

7. External System Integration

The system should be able to integrate with CDMS/ CTMS systems to get the study, site, patient and other information and should be able to dynamically create Directory Structures and upload documents

8. Remote monitoring with Sharing and Collaboration

A good eTMF system should allow a user to invite external parties to upload and work collaboratively on a document system in a controlled method as it is essential for such systems to integrate and exchange information with one another.

9. Inspection Ready & Regulatory Compliance

The system should have Inventory and complete audit reports which can be shared with the Regulatory auditors during the audit which shall give complete overview and history on how the study documents are captured and filing in the eTMF repository.

The system should also maintain an audit trail for every operation and should have fully compliant eSignatures for all stakeholders.

It should also comply with all current and regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

10. Advanced Analytics to track Completeness, Quality & Timeliness

The system should consist of interactive dashboards having analytics which will help business users to gain powerful and actionable insights. Importantly, the system should have dashboards to monitor the completeness of the study, Quality of the documents collected, and timeliness of the Study / Country / Site document filing and reviews.

Hope you found this article informative. Please reach out to arun.g@clinevotech.com, if you have any comments.

Data collected in clinical trials are complex, vast and growing uncontrollably with the number of clinical studies, clinical research softwares and vendors present in the clinical research market. For one study, a Clinical research company must work with several different vendors and software including

• CDM/EDC Systems (like Oracle Clinical/RDC, Inform, RAVE, Open Clinica, Clinevo EDC etc.)
• Safety Systems (like Argus, ArisG, Clinevo Safety, etc.)
• CTMS Systems (like Siebel Clinical, Clintrace, Clinevo CTMS)
• SAS-Based Systems
• Cloud-Based Systems
• Legacy Systems
• Spreadsheets
• Local and Central Lab Systems
• EMR/EHR Systems
• Regulatory Submission Systems.

Can you store, access and interact with all your clinical trial data in one place?

Data from all these different systems/sources being in different formats, makes impossible to get all the data in one place.!

What is a Clinical Data Warehouse?

A Clinical Data Warehouse or a Clinical Data Repository is a real-time database that consolidates data from a variety of clinical, safety and non-clinical sources to present a unified view.

All the data like Clinical Data, Operations Data, Safety Data, Lab Data and other data of one study can be available in one place for review, reporting and analytics. A Business intelligence tool in combination with a Data warehouse can enable you to know the progress of the trial in real time and enables you to monitor and take right decisions at the right time.

• Storage
• Review
• Standardization
• Aggregation
• Analysis
• Submission

Data warehousing enables you to perform

• Cross study analysis
• Data harmonization
• Data reconciliation
• Data recording
• SDTM transformation
• Data Aggregation and
• any business processes

Purpose of a Clinical Data Warehouse:

Purpose of Clinical Data Warehouse lies somewhere in its definition itself i.e. a database created by combining data that is gathered through various sources that can be of different types and formats (e.g. oracle, SAS, text, sql, xml etc.).

In a nutshell, Data Warehouse is a process of collecting data, transforming it, loading into single database and then using a BI (Business Intelligence) tool to answer your analytical queries and prediction of any further questions that may arise are helpful to your domain or business.

Benefits of a Clinical Data Warehouse:

Below are a few benefits of implementing a Clinical Data Warehouse for your Clinical Trials:

1. Improving Visibility of Data / All-in-One Platform:Clinical research organizations process data in different systems, which support the various business processes. In order to create an overall picture of clinical, operations, safety, non-clinical, lab and other data for sponsors and CROs – thus creating a single version of the truth – the data must come together in one place and made compatible. Both external (from the environment) and internal data (from various systems) should merge into the data warehouse and then be grouped. Therefore, having a single source to answers all your queries.
2. Improved Performance: One could use an already existing operational database if there is only single database for all the data, yet there few constraints like performance which degrade for both operational processes and reporting processes. Therefore, we create a database tuned and optimized database which will be ready to answer queries which require to bring huge amount of data and analysis.
3. Increase Data Quality: Users frequently overestimate the quality of data in the source systems. Unfortunately, source systems often contain data of poor quality. When we use a data warehouse, we can greatly improve the data quality, either through – were possible – correcting the data whilst loading or by tackling the problem at its source.
4. Faster Decision Making and More advanced Reporting: The structure of both data warehouses enables end users to report in a flexible manner and to quickly perform interactive analysis based on various predefined angles. They may, for example, with a single mouse click jump from year level – to quarter – to month level and quickly switch between the clinical data and the operational data whereby the indicator remains fixed. In this way, end users can juggle with the data and thus quickly gain knowledge about business operations and KPIs (Key Performance Indicator). Some metrics like – Which Site is not performing well? Which Investigator is not performing? Which patient is not regular for trials? Can be zeroed in in no time to find out the bottle necks of a trial and take necessary action time to avoid delays in the trails because of non-performing factors.
5. Regulatory Compliance: Clinical data warehouse stores audits of every action and stores data snapshot of data of different timestamps and provides version controls for the loads and programs which can help convincing the auditors on the data security, data handling and single source of truth.

About Clinevo Data Warehouse:

Clinevo Data Warehouse is an easy to use, secured, regulatory compliance clinical trials data repository & warehouse to acquire, store, transform, consolidate and report diverse data of clinical trials in one place.

Features of Clinevo Data Warehouse:

1. One Clinical Data Repository:
   • Holistic view of all clinical, safety and operational data of a clinical trial in one place
2. Wide Range of Tech Type Integrations:
   • Oracle, SAS, Text/CSV, XML, SQL Server, web services Imports
   • Oracle PL/SQL and SAS programs
   • SAS, TEXT, XML, Oracle Extracts
3. Inbuilt Business Process
   • Data Harmonization – Harmonize data from different source structure to one target structure
   • Data pooling – To the database schema (or) to remote DB with security
   • Data masking – supports various approaches
4. Increased Efficiency and Automation
   • Robust incremental refresh to get the data refreshed within 4 hours from a heavy Source system
   • Incremental data refresh for non-primary key tables
   • Incremental data refresh based on data element group
   • Parallel Data Loading
   • Configurable Automated Data Loads
5. Clinical Metadata Repository (MDR) Integration
   • Any Clinical MDR systems (COTS) or Legacy systems can be integrated with CLIDAC directly (or) thru web services to get the metadata.
6. Audit/ Regulatory Compliant
   • 21CFR part 11 regulatory compliance
   • Audit trail for every operation
   • Complete user tracking

Read more about the features of Clinevo Data Warehouse:

https://www.clinevotech.com/products/data-warehouse