Client Services
TMF Management
Sentinel consultants perform preliminary TMF stakeholder interviews and root cause analyses to customize solutions which enable the implementation of flexible, powerful TMF solutions. Our team partners with your Records Management group, adapting our approach based upon your document filing systems, SOPs and structures. Traditional eTMF deployments often fragment the associated tasks of creating and managing documents. Meaning the person creating a document might not have needed permissions to file the document into the TMF or add the appropriate metadata fields. This fragmentation and inefficiency creates document churn due to increased errors and QC rejections. Our team leverages a pod approach, incorporating dedicated specialists who partner with study teams, handle TMF Completeness Reviews and day to day document processing activities. We can help you achieve a steady flow of content into your TMF using a small, centralized team of TMF administrators. 
Inspection Readiness
Sentinel Document Specialists perform a comprehensive review of your study specific TMF (both site level and study level files) to determine overall inspection readiness, by interviewing the study team, conducting pre-review questionnaires, as well as inspecting each zone, sub-artifact and artifact to determine if the filing locations make sense, if documents are missing or misfiled, if metadata is accurate and effective. Our experienced inspection specialists have assisted in internal audits as well as regulatory inspections and can anticipate potential areas of risk to proactively address any gaps that could result in findings. Our goal is to create a complete, inspection ready Trial Master File which any document stakeholder can confidently rely on during an inspection.
Document Processing / Backlog Reduction
Often during the study life cycle priorities shift which can disrupt the flow of documents into the TMF. This causes issues when documents pile up, personnel move off the study team or the company receives notice of an FDA or EMA inspection. We can assist you by providing ample resources to quickly and efficiently bring your TMF up to date via reducing document backlogs, performing completeness reviews and addressing gaps identified during study and site level file reviews.
Systems Gap Analysis
Are your EDC, IRT, CTMS and eTMF systems communicating? Are you leveraging system reporting and dashboards to provide your teams with real time status updates of the TMF vaults? Our team of consultants can assist with enabling your organization to gain a true understanding of current state while planning for a streamlined future state. 
Response to Audit/Regulatory Findings
Even the best study vaults and TMF systems have gaps. The regulatory authorities understand this when issuing findings. Ideal state is 100% compliance. Inspectors look to see aggressive, proactive responses to any findings reported. Our team has the experience and capability to confidently address any findings as well as develop practical solutions that can be implemented and maintained for real world scenarios.
GCP Training
Sentinel maintains a robust training suite for all aspects of document management. Whether it be paper to electronic document management transitions, eTMF structures and processes, working with CROs or records management tool development, we can customize a training approach to your particular business needs.
SOP Implementation
Are your SOPs logical, easily understandable, tailored to the practicalities of your day to day operations and being consistently followed? We can help with SOP reviews and updates, enabling better alignment with department process requirements. Companies that can show consistent application of SOP processes minimize inspection findings and increase the likelihood of regulatory approvals.
Systems Implementation and Innovation
Are you setting up a new eTMF System or updating an existing system? Sentinel has experience using many major eTMF systems and can help you evaluate which eTMF system will make your TMF inspection-ready. Our team of consultants can also help you create real-time dashboards, advanced reporting, and integrate your TMF with EDC, IRT, CTMS and other e-clinical systems.