PharmaReady™ 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 can be indexed based on Site IDs, Study Numbers, Protocols, file types, etc.
- Robust search engine facilitates search based on free text, indexed parameters, activity dates, document metadata in addition to the user defined index parameters
- Ease of implementation, usage, training and also customer specific configuration in terms of creating templates, folder structures, seeding data, etc.
- In-built batch upload utility that enables loading and indexing of legacy study documents into the system
- 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
- Comes with an open architecture that enables integration with other systems such as CTMS, ERP, etc., via plug-ins or web services
- Fully 21 CFR Part 11 compliant document management solution based on Microsoft technologies
Why TAKE Solutions?
TAKE is a Leader in life sciences industry, providing solutions and services that make regulatory processes globally compliant, more efficient and predictable. We understand the intricacies regulatory compliance. TAKE brings you the combined advantage of:
- Specialized products
- Domain expertise
- Technology skills
- Strong, motivated project teams
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