Med- Tech Industry (Medical Device)
ELECTRONIC DATA CAPTURE FOR
Med- Tech Industry (Medical Device)
Companies developing medical devices and equipment use XcelTrials for managing clinical data related to the safety and efficacy of their products. It assists in compliance with regulatory requirements specific to medical devices.
Medical Device Manufacturers require specific features and capabilities to manage clinical data related to the safety and efficacy of their products. XcelTrials provides the following features tailored to the needs of Medical Device Manufacturers:
Regulatory Compliance
XcelTrials ensures compliance with regulatory standards specific to medical devices, such as ISO 14155:2020 and 21 CFR Part 820, to meet the legal requirements for clinical data management.
Customizable Data Collection Forms
Medical Device Manufacturers can create custom data collection forms to gather information relevant to their specific devices and studies.
Device Tracking and Documentation
The platform allows for the tracking and documentation of medical devices used in clinical trials, ensuring accurate records of device usage and performance.
Patient Data Management
Efficiently manage patient data, including information related to device usage, patient outcomes, and adverse events.
Data Security
Robust data security measures are in place to protect sensitive patient information, ensuring data privacy and compliance with regulatory requirements.
Validation Checks
Implement automated data validation checks to reduce errors and ensure data quality in the context of medical device studies.
Customizable Regulatory Templates
Access and customize regulatory templates designed for medical devices to ensure that documentation complies with industry-specific standards.
Data Analysis and Reporting
Generate detailed reports and analytics to assess the performance and safety of medical devices, facilitating data-driven decision-making.
Remote Monitoring
Enable remote monitoring of clinical trials, allowing manufacturers to oversee device performance and data remotely, reducing the need for on-site visits.
Integration with Device Monitoring Systems
Integrate with device monitoring systems to gather real-time data from medical devices, enhancing data collection and safety monitoring.
Adverse Event Tracking
Track and report adverse events related to medical devices, ensuring that safety issues are promptly addressed and documented.
Document Management: Efficiently manage device-related documents, including device manuals, instructions, and usage guidelines.
Collaboration Tools
Facilitate communication and collaboration among cross-functional teams involved in medical device studies, including engineers, clinicians, and regulatory experts.
Electronic Signatures
Support electronic signatures for approvals and authorizations, streamlining the approval process for device-related documents and data.
XcelTrials empowers Medical Device Manufacturers with the tools and features necessary to conduct clinical studies, ensuring the safety and efficacy of their devices while maintaining regulatory compliance and data integrity.
CLINICAL TRIAL MANAGEMENT FOR
Med- Tech Industry (Medical Device)
Dashboards
Through research dashboards, you may gain insight into all states of current investigations.
All of the information required for inspections and year reports is easily accessible via management dashboards.
Financial Management
Budgets, costs, and reimbursements must all be managed.
Connect the CTMS and EDC tools to arrange visits and gather data at each participating facility.
Study request, Amendments & Reports
All changes and progress reports should be generated inside CTMS and approved by a Medical Ethics Review Committee (MERCs).
Workflow Management
CTMS processes for study requests are built in accordance with the personal workflow. As a result, all roles involved may conduct the required activities per step swiftly and efficiently inside a single environment.
Create a number of processes. This is useful for distinguishing between Medical Research Involving Human Subjects Act study requests, modifications, and progress reports.
Communication Management allows for easy communication with all associated roles from all participating centers within CMTS.
Different responsibilities and privileges may be assigned to each participating site using Role Based Access Control.
Application Programming Interface (API)
Allow the EDC to easily interface with apps via an API.
Connect EDC to SURFcontext, a single sign-on (SSO), and an EPD. Furthermore, exchange data with financial and human resource systems, or stream data to the eCRF.
Good Clinical Practice (GCP)
Audit Trail
Data validation on field level
Anonymized patient details
Smart Safety Reporting
Role Based Access Control
