PharmaReady Electronic Trial Master File
PharmaReady’s electronic Trial Master File (eTMF) solution - is a 21 CFR Part 11 compliant solution that fits perfectly well with DIA’s Reference Model for the TMF (Version 1.0, June 4, 2010). It is a web based application that enables CRAs, Principal Investigators, Study Managers and others associated with both local as well as global clinical trials which cuts across multiple geographies to read, review, perform quality checks, search and track all study related documents that are stored in the desired convenient location and is transported to a central repository.
Documents put into PharmaReadyTM eTMF by sponsors, subsidiaries, CROs and other personnel associated with the clinical trials can be indexed based on Site IDs, Study Numbers, Protocols, file types, etc. PharmaReadyTM eTMF’s robust search engine facilitates search based on free text, indexed parameters, activity dates, document metadata in addition to the user defined index parameters.
The power of PharmaReadyTM eTMF lies in its ease of implementation, usage, training and also customer specific configuration in terms of creating templates, folder structures, seeding data, etc. PharmaReadyTM eTMF comes with an in-built batch upload utility that enables loading and indexing of legacy study documents into the system. There is also an in-built batch export utility that enables all the study related documents to be copied onto an external storage device (CD/DVD) with the exact directory structure maintained for distribution to the external entities.
Also, all study related documents in PharmaReadyTM eTMF can be directly used in PharmaReadyTM eCTD and create electronic submissions for the regulated markets such as US-FDA, EU and HC.
Last but not the least, PharmaReadyTM eTMF comes with an open architecture that enables integration with other systems such as CTMS, ERP, etc., via plug-ins or web services.
The PharmaReadyTM eTMF Consulting team can provide strategic planning and support in implementing an electronic centralized method of compiling, storing and archiving the TMF documents. The PharmaReadyTM eTMF Consulting team is highly qualified to assist sponsors to organize and implement TMF to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GxP and with applicable regulatory requirements.
Business Problem |
Existing Scenario at CROs |
PharmaReady DMS / eTMF Advantage |
Installation & Configuration |
Complex installation cycles running into several months |
Typical installation cycle is less than a week |
Regulatory Compliance |
Legacy software solutions not compliant with the GxP and/or CFR guidelines |
Fully compliant with 21 CFR Part 11 and GxP guidelines in addition to DIA’s latest Reference model for the Trial Master File |
| Access to Study Related Documents | Generally via Email, on CD/DVD, or Hard Copies that become very difficult to collate, manage and control | All study documents stored in a central repository with inherent life cycle management that enables study personnel controlled access to LIVE data from any location |
| Notifications | Mostly never automated and have to be initiated on a need basis | Automated Email notification system that alerts users on pending tasks and completed actions. Automated Email Reminders sent to users if designated task is still pending |
| Indexing and Searching | Use stovepipe legacy software solutions that are not enterprise-wide, thus being incomplete and incomprehensive | All document indexing and search based on free text, metadata, user defined fields, etc performed comprehensively on documents within the enterprise-wide document repository |
| Batch Uploads and Exports | Very time consuming and requires a lot of manual processes if a software solution is not present | Robust batch upload and export utilities that enable users to upload and export documents while maintaining their directory structure or hierarchy |
| Security | Cannot control printing and distribution of documents within or outside the organization, thereby resulting in pilferage and misuse of sensitive and proprietary data | Strict print and read options built into the system so that strict control can be maintained over documents that are distributed to users |
| Audit Trail | User activity and document access information not available or not maintained, there by resulting in queries during internal or agency audits | All events, actions, and dates along with the user ids are recorded in the audit trail that is read only. Document control information can also be appended to published documents, thereby ensuring successful audits |
| System Integration | Integrating various software solutions that cater to various business needs almost impossible | Open ended architecture that allows integration with CTMS, ERP systems via web services that enable extraction /transfer of document and meta data |
| Regulatory Submissions | Generally require all Study related documents to be made available offline to a regulatory publishing tool | All study related documents can be loaded into the PharmaReady eCTD module directly thereby ensuring that the most recent version of the study related document is being used in the submission |
| Support | Time consuming when users across various geographies require assistance | A dedicated support team provide 24x7 Email, Phone and LIVE support to users located anywhere |
