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For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing research data to produce high-quality information and reliable results in compliance with local regulations and good clinical practice.
To effectively manage data from clinical investigations, MedTech companies can implement either a paper-based data management approach or go for an electronic Clinical Data Management System (CDMS).
In this blog, we’re taking a closer look at the role of CDMS in medical device clinical trials and how MedTech can use electronic CDMS to collect, manage, share, and validate clinical data.
A clinical data management system is a software tool used to collect, manage, share, and validate data in clinical investigations.
In the course of a medical device clinical trial, clinical investigators collect and record data from trial subjects on Case Report Forms (CRF). This data is stored in the CDMS where it can be accessed by clinical trial sponsors, screened and validated, shared with regulatory authorities, and ultimately analyzed to determine the results of the study.
Some medical device companies depend on a paper-based CDMS solution for clinical investigations, while others have switched to electronic CDMS - so what’s the difference?
With a paper-based approach, investigators manually complete paper CRF forms at the investigator site and mail them to the clinical trial sponsor. When CRFs are received by the sponsor, data entry teams input the data into the CDMS software. Double data entry is often used to mitigate human error during this data entry process. Paper forms may also be mailed back and forth between trial sponsors and investigators to communicate about data validation issues.
With electronic clinical data management system solutions, investigators prepare electronic case report forms (eCRF) and upload them directly to a web-based software application where the data can be immediately accessed by trial sponsors and other stakeholders. During the data validation process, clinical investigators can be notified about issues via electronic alerts instead of by mail.
In addition to eliminating paper waste in clinical investigations, electronic CDMS solutions help medical device companies run clinical trials faster and more efficiently by enhancing the availability, reliability, and security of clinical data.
ISO 14155:2020 is the international standard for good clinical practices when it comes to clinical investigation of medical devices for human subjects. Electronic CDMS software should be out-of-box compliant with ISO 14155:2020, specifically with section 7.8.3, which indicates best practices for implementing electronic clinical data systems.
Electronic CDMS solutions deliver eCRF design capabilities, allowing clinical trial sponsors or investigators to build customized eCRF forms according to the specific data collection requirements of their study.
Electronic data capture (EDC) is a core function for any electronic clinical data management system. EDC functionality includes a user interface for data entry into the system, a validation component to help ensure that data is recorded accurately, and reporting tools for analyzing the data.
Adverse event (AE) reporting is legally mandated for medical device clinical trials in most jurisdictions. Electronic CDMS solutions often provide specialized modules or tools that clinical investigators use to report on AEs to the clinical trial sponsor.
In addition to capturing eCRF data recorded by clinical investigators, some electronic CDMS solutions have the ability to collect data directly from patients, known as electronic Patient Reported Outcomes (ePRO) with integrated email and SMS messaging capabilities.
Clinical trial sponsors can configure electronic CDMS solutions to send automatic notifications to select users after a triggering event, such as when a subject is enrolled, when a randomization blind is broken, or when a new AE report is created.
Electronic CDMS solutions allow medical device companies to export clinical data in a variety of formats. Exported data may be analyzed using external analytics software tools, or shared with regulators at the conclusion of a study.
Modern electronic CDMS solutions store clinical data on public cloud infrastructure that offers high levels of data availability and security.
With electronic CDMS solutions, any data uploaded by clinical investigators is immediately available to clinical trial sponsors, data validation teams, and other stakeholders. The ability to quickly share data enables faster and more effective collaboration between stakeholders in a clinical investigation.
Electronic CDMS solutions help medical device companies execute clinical trials in less time, with less risk, and at a lower cost than with a paper-based system.
Electronic CDMS accelerates the reporting of AEs and serious adverse events that could impact the safety or risk assessment of a clinical trial. Medical device companies can use electronic CDMS to automatically alert on newly reported AEs and maintain closer oversight of clinical investigations.
Greenlight Guru Clinical is an electronic CDMS, purpose-built for the clinical investigation needs of medical device companies.
Greenlight Guru Clinical offers EDC capabilities along with eCRF design and customization, automatic notifications, electronic PRO data collection, an adverse event reporting module, and pre-validated compliance with the Good Clinical Practices standard, ISO 14155:2020.
Schedule an introductory call with us and discover how you can maximize clinical trial efficiency with Greenlight Guru Clinical.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.