Services Clinical Development Early Stage
Record Management
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Accuracy to the Last Detail: Precision Personified in Study Documentation
TMF – The Backbone of Clinical Trials
The Trial Master File (TMF) forms the crux of any clinical trial, safekeeping key documents that may be under regulatory scrutiny. Recognizing this cruciality, our Record Management team is wholly committed to the precise design and operational maintenance of this central repository.
Conquering the TMF Complexity
Navigating in a TMF, with its potential for thousands of documents and records, can be a daunting task. Couple this with the data flow from multiple vendors in large-scale, global studies, and the task appears immense. But fret not, for with Accelsiors, you have an unwavering partner.
Expert Management of Clinical Trial Documents
Harnessing our systems and processes, we offer adept management of vital clinical trial documents, assuring real-time readiness for inspection, heightened visibility, and control. Our centralized Record Management team is deeply committed to vigorous and preemptive TMF management.
ADAM – Your eTMF Platform for Enhanced Productivity
Enhancing our efforts is our eTMF platform, Accelsiors Document Access Management System (ADAM). This web-based, fully validated, CFR 21 Part 11 compliant system embodies all features of leading electronic record management software, inclusive of electronic signature capabilities to amplify productivity across the organization. Our file structures are rooted in the TMF Reference Model, offering direct access to facilitate remote audits, inspections, and monitoring.
Our Priorities
- In-Depth Document Management Planning: Critical during a project’s start-up phase
- Comprehensive Training: Ensuring meticulous documentation practices
- Proactive Document Management: Coupled with responsive feedback
20 Years of Global Experience at Your Disposal
With our two decades of international experience, we appreciate the weight of detailed document management planning, especially during the demanding initiation phase of a project. We work in close collaboration with you to organize the eTMF and develop a detailed TMF Management Plan, outlining all specifics, structures, and responsibilities. Choose Accelsiors, your reliable partner, for unwavering and proactive management of study TMFs.
Accelsiors eTMF: Illuminating Clinical Trials with Transparent and Intuitive Document Management
At Accelsiors, we harness the power of our proprietary eTMF solution, Accelsiors Document Access Management (ADAM). ADAM is not just another system – it is a robust, intuitive, and ever-evolving tool built to revolutionize how we handle eTMF.
Document Management in a Cloud
Centralized Cloud Repository allows you to store all eTMF documents securely in the cloud. The clinical study team will experience global access and collaboration while maintaining the utmost security.
Customizable Metadata is the key to the proper organization of documents. Flexible templates help capture and retain essential information, being a basis for intellectual tagging and classification of documents.
Collaborative Review Tools facilitate multi-site document oversight with online annotation, version control, and streamlined approval workflows.
Automation and Analytics
Bulk uploads and exports of documents, automated notifications, and alerts, predictive analytics save time and help reduce compliance risks and avoid audit findings. AI-based enhancements that provide both interactive human-like reasoning and advanced processing are under active development.
Robust Search Functionality lets a user find files effortlessly with intelligent search algorithms that respond to natural language queries. Dashboards and reports provide structured real-time insights into review status and metrics.
Application Programming Interface (API) simplifies seamless integration with external systems as well as Data Extraction & Reporting.
Access Control and Security
Role-based access control, document version control, and Audit Trails ensure that sophisticated permission policies are put in place, and the whole eTMF is audit-ready.
By seamlessly integrating intuitive interfaces, collaboration, mobility, automation, and cutting-edge AI, Accelsiors eTMF tames the complexity of clinical trial document management. It’s not just a system; it’s the future of efficient and compliant clinical trial operations.
Record Management Services we offer in alignment with international standards:
- Record Management Plan Development: Creating a comprehensive plan detailing all aspects of document management, including processes, roles, timelines, and tools.
- TMF/eTMF Setup: Developing and implementing a Trial Master File or electronic Trial Master File system, customized to the needs of the project.
- Compliance Reporting: Regular reports to ensure all documentation processes align with regulatory standards.
- Document Classification and Indexing: Implementing a structured and systematic approach to classify and index documents for easy retrieval.
- Archiving Services: Securely storing all trial documentation following study completion in compliance with retention regulations and guidelines.
- Audit Readiness: Ensuring the TMF is always ready for internal and external audits or inspections by regulatory authorities.
- Document Quality Control: Regular reviews to verify the completeness, correctness, and consistency of documents.
- Migration Services: Safely moving records from one system to another while preserving data integrity and security.
- Training Services: Providing extensive training to all relevant team members on document management systems and procedures.
- Document Destruction Management: Safely and securely disposing of documents that have reached the end of their retention period, in compliance with applicable regulations.
- Disaster Recovery Planning: Implementing strategies and procedures to recover and protect the business IT infrastructure in the event of a disaster.
- Vendor Management: Coordinating with vendors involved in various aspects of record management.
- Process Optimization: Continually reviewing and improving the document management process to enhance efficiency and effectiveness.
