Electronic document indexing
Scanning
Trial Master File management
Electronic document indexing
While most pharmaceutical companies have systems in place to retain their paper archives, not all have extended these systems to include electronic data. With the acceptance of electronic signatures and the growing practice of electronic CRFs, there are times where the Sponsor has no real need for a paper original (except for regulatory purposes). Phlexglobal continues to be at the forefront of dealing with this transition from paper-dependent to paperless clinical trial data management. We have a professional Indexing Team, trained in clinical documentation and experienced in a variety of clinical filing hierarchies. One of the biggest growth disciplines in clinical research, electronic document indexing can be performed at the sponsor site or, if preferred, brought into Phlexglobal’s own offices for a dedicated, confidential and unique service, including, for example,
Thin client interface (via client’s portal or CD),
No limit to size (no minimum, no maximum),
Transfer of paper pharmaceutical and medical records,
Management of E-mails & unique electronic documents.
Scanning
Due to its expertise in document management, Phlexglobal is ideally placed to offer a document scanning service. We offer in-house scanning, primarily for Clinical and Regulatory departments. Our dedicated Scanning Team is trained in clinical documentation. Phlexglobal typically scans documentation into a system that allows the images to be offered as TIFFs, OCR PDFs, etc and as such is very flexible tool. We can, if preferred, utilise other specific Document management programmes according to client needs. The scanning service, in alliance with the indexing service, offers a complete Electronic document management solution, including, for example,
Project management (linked to other function/services),
No limit to size (no minimum, no maximum),
Controlled, secure and confidential environment,
‘Prepping’/‘de-prepping’ and ‘re-filing’ of all scanned documents,
Document collection and delivery.
Trial Master File management
All companies are familiar with the concept of the Trial Master File (TMF) and will have specific and generic SOPs to deal with the management, collection and distribution of documents generated throughout the whole of the clinical trial process. Our experience with a wide variety of clinical trial documentation (paper and electronic!) gives a unique opportunity to advise on TMF management.
Whether offering a straightforward review of your SOPs regarding TMF structure and design to the physical management of large central TMFs or their relationship to local subsidiary trial filing systems, we understand the issues that need resolution and we have the skills to deliver such a resolution in a cost-effective timely manner.
Our document management Team offers the best solution for your Trial Master File Management support, including, for example,
Contact Karen Roy at Phlexglobal today (01494 720420, kroy@phlexglobal.com) for more information.
