All companies in the pharmaceutical industry must maintain a trial master file (TMF) for each clinical trial they sponsor. Even though regulatory guidance (such as ICH E6) exists, there is no comprehensive common model for managing those documents. Typically, a company is left to interpret the guidance and develop a unique TMF management strategy – one based on institutional knowledge, past experience and opinion.
In 2009, the Drug Information Association (DIA) embarked upon an effort to define a standard clinical trial master file taxonomy or "reference model" for use by industry. This collaborative effort involved over 120 representatives from 87 biopharmaceutical companies, contract research organizations, consultancies, technical vendors (including NextDocs), and regulatory agencies.
At NextDocs, we aligned our eTMF solution with the DIA TMF Reference Model from the start – providing our clients with a comprehensive document inventory out-of-the-box. Our clinical collaboration platform simplifies the management of essential trial documentation by effectively integrating document management processes with the way people work on a daily basis. Workflows, not people, drive the creation of many documents.
The eTMF Management solution provides:
- Comprehensive Document Inventory
- Automated Trial Workspace Creation
- Trial, Country and Site Specific Document Checklists
- CTMS Integration
Comprehensive Document Inventory
NextDocs provides a preconfigured document inventory that is directly aligned with the DIA TMF Reference Model. A predefined suite of content types, metadata, reference lists and folder structures can be used as is or tailored to meet company specific requirements. NextDocs innovative Smart Document feature simplifies document creation, indexing, naming and filing so your eTMF is always compliant with your quality standards.
Automated Trial Workspace Creation
At any given time, a pharmaceutical company can be actively engaged in hundreds of clinical trials. Imagine the effort and overhead involved with provisioning collaboration websites to support that volume of work using traditional web development methods. NextDocs leverages SharePoint's workspace templates to facilitate the rapid creation of collaboration websites and basic content. Any number of new websites (aka workspaces) can be generated from a template, which is a set of content pages and schemas (which are themselves stored on the web server as a set of HTML and XML files). A workspace template contains specific design information about a website, including the data structures that are part of that website, user interface components used in the website, the website's themes and borders, navigation, as well as some content (such as document libraries).
Study, Country and Site Specific Document Checklists
Every company maintains checklists of required documents that must be received from each investigational site before, during and after the trial. Many times the checklists are maintained in spreadsheets or departmental databases. Most time, little or no automation exists between eTMF repository and these checklists. NextDocs provides a preconfigured suite of document checklists specifically designed to track the inventory of documents that must be received and accepted into the eTMF to achieve a specific milestone. These checklists are defined at the Study, Country and Site level. Country and Site-specific checklists are created when countries and sites are selected to participate in the study. As documents become records in the eTMF, a NextDocs supplied workflow action automatically updates the status of its corresponding checklist entry so study personnel can easily determine which documents have been received and which are still missing.
CTMS Integration
Many clinical trial sponsors have implemented clinical trial management systems (CTMS) to optimize trial planning and execution, manage investigator relationships and track clinical trial milestones. At NextDocs, we understand that the ability to exchange information with your CTMS is a very important component of a comprehensive clinical solution. In fact, much of the information that is used to drive the NextDocs clinical solution is often housed in a CTMS – specifically the characteristics of the trial, the investigational sites participating in the trial and the clinical personnel working on the trial.
NextDocs offers CTMS integration as part of our clinical solution deployment services. Using Microsoft's SQLServer Integration Services (SSIS), NextDocs can surface data from your CTMS without any coding - making clinical trial data available within your NextDocs clinical solution and accessible by collaboration partners at anytime from anywhere.
Contact us to learn more about our Electronic Trial Master File solution.