CROs, biotechnology, and pharmaceutical companies use software to facilitate clinical trials from design to finish. Clinical trial management software includes eTMF, Clinical Data Management (CDM), eConsent, Patient Management, Electronic Data Capture (EDC), Protocol management, CRF design, and many more.
The importance of this software in the new era of clinical development is increasing day by day as researchers conduct multiple clinical trials at time, handle multiple tasks, need to be efficient, and comply with regulations. Using software helps maintain transparency from start to finish and achieve all such goals.
In this article, let’s discuss a few products such as eTMF, Clinical Data Management (CDM), Patient Management, eConsent, and Electronic Data Capture (EDC).
What Is an eTMF?
TMF stands for Trial Master File, and if this is managed electronically, it is called an Electronic Trial Master File (eTMF). The electronic Trial Master File (eTMF) is an application that leverages software and server technology to guide and assist in the setup, collection, storage, tracking, and archival of essential clinical study documents.
Simply the Trial Master File (TMF) is a structured collection of clinical trial documents to show evidence of regulatory compliance, allowing the conduct and quality of data collection to be evaluated. The Trial Master File (TMF) contains documents collected at study level, country level, and site-level at multiple points, from startup to study close.
Why does your clinical trial need an eTMF?
The goal of the EU and FDA is to ensure that sponsors and investigators are going with the principles and guidelines of good clinical practice (GCP). Using such software for document management help achieve goals flawlessly.
The Trial Master File (TMF) is considered essential for Good Clinical Practice (GCP), and GCP is a requirement by regulatory agencies such as the FDA.
Management of TMF electronically is simple and holds good benefits.
Benefits of an eTMF
There are several benefits of ETMF for your clinical trials, and here are a few of them
- Setup and reuse
- The eTMF skeleton structure can be used for future studies.
- Access data from anywhere
- Stakeholders can upload, manage, and access documents from anywhere
- Secure storage & archival
- Documents in the eTMF can be stored in a secure, and reliable manner with only access to your team.
- Regulatory compliance
- eTMF ensures all the clinical trial documents are within the regulatory standards.
- Quick tracking
- eTMF provides quick tracking of documents and notifies missing documents to meet regulatory compliance.
Patient management software helps manage, organize, and track treatments and visits of patients in clinical trials. It improves participant patient experience and provides an end-to-end clinical trial management solution that tracks the journey of the patient on a single platform.
Ideal patient management software
An ideal patient management software helps to alert, set reminders, and schedule management for study visits, trial medications, and study-related activities (e.g., diaries, PRO completion, etc.). It also helps to motivate and maintain compliance, provides trial-specific education, and facilitates omnichannel communication.
A typical patient management software includes eDiary, ePRO (electronic Patient-Reported Outcomes), and eCOA (electronic Clinical Outcome Assessment) for end-to-end support.
Patient management software compliance
Patient management software needs to be compliant with HIPAA, GxP, CSV, 21 CFR Part 11, and other necessary regulatory guidelines.
Clinical Data Management (CDM)
What is Clinical Data Management (CDM)?
CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards.
The design of the CDM process allows the delivery of an error-free, valid, and statistically sound database. And to meet this objective, the CDM process needs to start early, even before the study protocol finalization.
What are the benefits of CDM?
- Clinical Data Management (CDM) is a critical phase in clinical research, as it leads to the generation of high-quality, reliable, and statistically sound data from clinical trials.
- CDM helps to reduce drastic time during clinical development and improve efficiency.
- Keep the number of errors and missing data as low as possible and gather maximum data for analysis.
CDM and Regulatory
CDM needs to follow guidelines and standards. These electronic records shall comply with a Code of Federal Regulations (CFR), 21 CFR Part 11. This regulation is applicable to records in an electronic format that is created, modified, maintained, archived, retrieved, or transmitted.
Hence it is necessary to use validated systems in order to ensure accuracy, reliability, and consistency of data with the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
What is e Consent?
eConsent allows patients to understand trial objectives while providing consent through multimedia technology onsite or remotely. During the pandemic, many sites started using eConsent as clinical research staff working from home couldn’t bring paper forms to patients, especially patients who had COVID-19, and quickly adopted eConsent software to help solve the problem.
It assists subjects to make informed decisions using multiple media resources and improves the quality of the study by enhancing patient experience, data quality, and electronic system.
Why do you need it?
To protect patient rights without compromising on the full potential of clinical research, flexible and dynamic consent formats will be crucial in the future.
eConsent helps in following ways
- Improve participant comprehension and reduce study drop-out
- Mitigates errors and improves workflows
- Provides valuable data insights to improve quality
- Enhances inclusion and diversifies study participants
- Allows trial investigators to make dynamic changes to consent data and protocol amendments while keeping the patients informed through instant electronic updates.
- Help increase the process efficiency by simplifying the consent communication.
- Provide the sponsors regular insights into consent activities.
How should an eConsent be?
eConsent should be regulatory-compliant and patient-friendly.
An ideal eConsent
- Easily share and collaborate on informed consent forms between sponsors and sites.
- Enable in-person or remote eConsent on any device
- Have version and audit controls
- Easy to edit consent forms
- Compliant with HIPAA and 21 CFR Part 11
Electronic Data Capture (EDC)
What is Electronic Data Capture?
An electronic data capture (EDC) system is a web-based software application used to collect, clean, transfer, and process data in clinical trials. Data is initially recorded on paper and is then transcribed into the system and saved in an electronic case report form (eCRF).
An electronic data capture (EDC) system is a computerized system designed to collect clinical data in electronic format for use in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data and expedite the clinical development process.
What dose an EDC system have?
- a user interface for data entry
- a validation component to check user data
- a reporting tool for analysis of the collected data
EDC increases data accuracy and decreases the time to collect data for drugs and medical device studies.
Advantages of using an EDC system in clinical trials?
Using an EDC system certainly provides several advantages during a clinical trial. Let’s see a few of them.
- EDC streamlines data collection when compared to paper-based data collection.
- Clinical sites can access the EDC system from any computer and enter data quickly and easily,
- Data managers can quickly review the data entered in the system and issue queries to solve discrepancies.
- EDC platform assures solid data authenticity, integrity, and security, as it integrates advanced mechanisms to manage access controls and data traceability.
- Assures data security
What are the regulatory requirements for EDC?
The EDC systems must meet part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
An ideal EDC system
- A user-friendly interface, designed to meet the specific needs of medical researchers
- A user-access controlled platform that facilitates collaboration among multiple sites and researchers around the world
- The ability to set data limits for all captured data to reduce human error
- Assured compliance with privacy and data protection policies, ensuring to meet mandatory regulations and that research data collected and maintained
- Seamless integration with existing tools, wearables, legacy systems, and other technology
- The ability to reuse research data for the initial research team, the statistical analysis team, and any future users of the data.
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