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Nov 12, 2015

eTMF Management: Don’t Settle for a One-Trick Pony!

When you search for an electronic 
master file (eTMF)  solution, be sure it 
is versatile and not a one-trick pony!

by Patricia Santos-Serrao 

MasterControl's Market Segment Manager

Global Pharmaceutical, Blood & Biologics


Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement.  With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

Defining your eTMF requirements

As any clinical professional will tell you, clinical study management involves more than just managing the documents that are generated throughout a clinical trial.  There are various factors that contribute to a successful clinical study, not least of which involves risk management, monitoring, audits, data collection, training, vendor management and managing protocol deviations, to mention a few.  The ability to holistically manage all of the activities, documents, and relationships involved in a study increases not only transparency but also efficiency. 

An often forgotten aspect of an eTMF is the need to exchange, share and collaborate on documentation with external parties such as clinical research organizations (CROs), sponsors, medical writers, principle investigators and other external contributors to the study.  A number of documents are originated from clinical sites, such as CVs, FDA forms and IRB approvals--- multiply these by the number of sites and studies a clinical associate interacts with and it can be a full-time job managing, importing and indexing documents.  A solution which enables clinical investigator sites to submit and manage documents directly into a study’s eTMF with little need for hand holding means that a clinical associate can spend more time focusing on added value tasks.  Additionally, a system that allows the ability to create, review, collaborate and approve documents with external partners such as CROs, medical writers and auditors means reduced review cycles on documentation and more control over intellectual property.



This article is related to the Whitepaper: How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials. To get the full details, please download your free copy.

Looking beyond eTMF requirements

The task of evaluating eTMF solutions requires the ability to look beyond the immediate needs of creating, reviewing and approving eTMF documents.  The management of an eTMF requires the ability to assess the current status and review cycles, responsibilities, and dependencies of documents in order to maintain control over information being collected and disseminated.  

While evaluating an eTMF solution, users will also need to factor in the use and dissemination of documents after the study has been concluded. Take, for instance, how the documents will be utilized and submitted in marketing applications worldwide to regulatory authorities such as the Food and Drug Administration (FDA) by their regulatory affairs colleagues. It is important not to be nearsighted when evaluating an eTMF solution.  Doing so will lead to investment in a solution that meets the needs of clinical as a silo, and not as part of a greater organization.  Here are some questions that a company evaluating and eTMF solution may want to ask themselves about a potential solution’s ability to go beyond eTMF management:

3rd Party Partners: Will this eTMF solution allow me to share, review and collaborate on documents with my external partners (i.e., CROs, investigators)?


As more companies outsource clinical activities to external partners, the need for inclusion of external users into day to day activities such as sharing of information and documents should not become a hindrance for “virtual” clinical study teams.  Study teams should have the ability to collaboratively and seamlessly work together on critical study documents and activities.

Clinical Quality: Can this solution manage clinical quality documents (i.e., Clinical SOPs which are not part of a standard “eTMF”) critical to ensuring that procedures documents are readily available to clinical study teams as needed? 


The eTMF collection of documents, although thorough in content for specific clinical study documents, does not include the management of clinical quality documents such as procedures, and SOPs which outline how activities should be conducted and how regulations are met (i.e., HIPPA, unblinding).  Having these clinical quality documents readily available in the same system (although not embedded in the eTMF) when questions arise can mean the different between procedures being followed, versus team members attempting to recall what they may have trained on months ago.

GCP Training: Can this solution manage GCP training and training records to ensuring clinical study teams are well informed of clinical procedures? 


These clinical quality documents are critical to day to day business and it is a clinical quality manager’s and study manager’s responsibility to ensure that all team members are informed of who, what, where, when and why clinical activities are executed.  Failure to do so will significantly impact the quality of the overall study. 

Regulatory Affairs: How will clinical study documents requiring submission to regulators be provided to regulatory operations? 


The ongoing interactions between clinical operations and regulatory operations are critical throughout a clinical trial.  Regulatory operations must submit ongoing amendments to investigator documents, protocol amendments, and adverse events, often on a daily and weekly basis.  An eTMF management tool that exclusively manages eTMFs and not regulatory submission documents will require that clinical export documents out of their system in order to import into a regulatory system, losing the ability to link source documents to submissions and maintain tracking of where documents have been submitted and when.


Eliminating silos, increasing transparency and efficiency

Silos are rampant throughout organizations, performing as  significant contributors to inefficiency and decreases in quality.  The right technology can and should significantly reduce silos and increase communications and sharing of information both internal and external to relevant parties.   Using a single platform for document management enterprise-wide will allow for configuration of functionality relevant to each unique functional area’s document management needs, meaning each area can get exactly what is needed for managing information without building virtual walls that will limit their ability to be nimble and transparent.

Multi-faceted steed

If you’re searching the herd for an eTMF solution that can do more than munch hay in the pasture, ask vendors these questions.  Ask follow-up questions and be persistent in getting the answers you need.  Ultimately you want a vendor eager to provide you with a multi-faceted steed --- not a horse trader who wants to unload a one-trick pony. 



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Patricia Santos-Serrao is a life sciences professional with almost two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry.  She is currently MasterControl's market segment manager, global pharmaceutical, blood & biologics.

Prior to joining MasterControl, Patricia held the position of manager, global regulatory safety for QUMAS, a company specializing in quality and compliance management software for life sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the pharmaceutical industry with a particular focus on submission document management for regulatory affairs and clinical trial master files (CTMF) for clinical.

She's worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in regulatory affairs and clinical.  She has assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling electronic common technical documents (eCTDs) and other submission format filings worldwide.  

A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor of Science degree in Business Administration. Patricia is a member of the Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).










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