Background

For any Pharma or Life Sciences company involved in conducting Clinical trials, maintaining / managing a Trial Master File (TMF) is inevitable. A decade ago, the master file enclosed heavy volumes of paper-based documents for majority of the clinical trials carried out. The only central location for these documents, supporting compliance requirements and good clinical practices, was a physical repository piled up with stacks of files. Such arrangement of documents led to discrepancies and inconsistencies in TMF in terms of file name, structure classification and information distribution among various stakeholders. Although there were companies that adopted an internal TMF structure that covers a better classification outline and content model for existing TMFs, it did not align with that of the TMF arrangement carried out by other clinical trial stakeholders in the industry.

To address the inconsistency in TMF structure, a source model was announced in 2010 that represented as a reference point for all clinical trial stakeholders in the industry. The new TMF model standardized document names, classification and descriptions that could be used commonly by majority of the stakeholders. It has been observed that companies utilizing electronic Document Management System for clinical trials witnessed higher degree of quality in clinical study, improved cost effectiveness and reduced timelines. Subsequently several pharma companies involved in clinical trials are eager to shift from huge volumes of paper-based CT documents to a centralized online mode of document management system.

Advantages for Pharma Companies by Implementing eTMF Models

In the era that is evolving constantly, organizations tend to move faster and expect the exchange of documents in a snap of finger and the accessibility of information from anywhere, anytime. In this context, Etmf delivers advanced features of document management with high data security to manage clinical trial information. From a business value standpoint, companies using eTMF solutions can be benefited in following aspects:

High Quality of Documents

eTMF is an automated document management system. Thus it offers very minimal scope of errors in document management as compared to paper-based processes, handled manually.

Abridged Overall Cost

Implementation of eTMF helps reducing overall compliance overheads since the extra costs incurred in manual auditing and report generation are saved.

Improved Accessibility

One of the major drawbacks with paper-based TMF management system is the difficulty in accessing a specific file remotely. eTMF eliminates these shortcomings and offers an easy and secured access for viewing, sharing, and retrieving any file from anywhere, anytime with customizable access levels.

What features should an effective eTMF solution entail?

While planning to integrate eTMF with their on-going practices, companies need to consider few key aspects that an eTMF solution should have.  Following are some of the features /aspects they should look upon:

End-to-end TMF Process

When looking for an eTMF solution, consider a complete package that offers services right from set up to configuration to management to reporting and auditing of Clinical Trial Documents. It should allow to create and index documents as per the agency’s TMF structure. Auditing is an essential element of a complete eTMF system, therefore the solution should also support internal and external audits in all aspects.

Flexibility

This aspect of an eTMF solution accounts for the performance and versatility in order to adapt to any kind of organization. A flexible solution should enable competency for both small and large clinical trials without disturbing the system performance.

Customizable

In order to be suitable for every kind of infrastructure comprising clinical trial documents, the solution must be highly customizable. Features like advanced search options, user management controls, monitoring activities, categorizing of groups, etc. accounts to a customizable eTMF solution.

Cloud Infrastructure

Remote accessibility is one of the prime features that an eTMF solution should have which enables companies to author, review and approve clinical trial documents and update global repository in real-time provided the solution is securely cloud-hosted. If an eTMF solution facilitates the cloud advantage, it will offer companies a comprehensive global access functionality.

In Conclusion

In order to take a leap from paper based TMF system towards electronic TMF system, companies need to implement a cost effective, ready-to-use and completely secure eTMF solution that effectively addresses the challenges involved in managing clinical trial regulatory documents. Not only should this eTMF solution implicate wide range of features that helps in seamless collection, classification, archiving, reporting or auditing of documents but also should be adaptable to mandates of regulatory authorities.