Clinical Research Services
Ensuring TMF quality is the single most important deliverable of a clinical trial.
Given the current attention to the TMF, regulatory agencies can show up at any time to perform a TMF Audit. Make sure your trial documentation is always inspection ready by having the experts at SOL CLINICAL guide you through the implementation of our proven tools for successfully managing a TMF. A mock TMF Inspection is your most powerful tool to evaluate the story held in your TMF and control regulatory risk; our team can provide you with peace of mind by creating or transforming your TMF into an inspection-ready trial management tool.
Our experts can support your TMF strategies in numerous ways, learn more.
Functional Service Provider.
Streamline your clinical trial operations and enhance quality by adopting an "a-la-carte" strategy. Outsource only the necessary components of your trial content management to reduce resource burdens while maintaining excellence.
Document Quality Control
Ensure superior document QC standards by using expert QC services for some or all of your TMF documents and files.
AI-powered TMF quality Control
Implement a cycle of Quality Control that continuously monitors the condition of your TMF.
Process Development
Develop a foundation of sustainable SOPs, work instructions, and processes to ensure that your TMF can be complete, accurate, and inspection ready at all times.
TMF Selection & Implementation
Which eTMF solution is right for you? Ensure an orderly transition with a stable foundation of detailed processes, whether transitioning from paper or between two eTMF systems.
TMF Reference Model Implementation
As TMF Reference Model Subject Matter Experts, Sol Clinical TMF Professionals specialize in indexing documents within the TMF Reference Model framework. Sol Clinical can work with your team to develop a complete TMF ‘Table of Contents’ that will establish clear expectations across your organization.
Document Filing &
Indexing
Eliminate document handling latency by engaging Sol Clinical team of TMF professionals to ensure your TMF is inspection ready upon closeout.
Training & Stakeholder Engagement
Training and Stakeholder Engagement are the cornerstones of every optimally functioning TMF department. Sol Clinical accredited and non-accredited training programs can re-energize teams and help instill a refreshing new perspective on TMF accountability.
Analytics To Give Powerful and Actionable Insights
Assess the completeness and quality of your TMF with powerful metrics and actionable insights.
Our experts can support your TMF strategies in numerous ways, learn more.
Functional Service Provider
Reduce resource burdens and increase quality by taking an “a-la-carte” approach – outsourcing only what you need to help manage your clinical trial content.
Document Quality Control
Ensure superior document QC standards by using expert QC services for some or all of your TMF documents and files.
TMF Quality Control
Implement a cycle of Quality Control that continuously monitors the condition of your TMF.
.
SOP & Process Development
Develop a foundation of sustainable SOPs, work instructions, and processes to ensure that your TMF can be complete, accurate, and inspection ready at all times.
eTMF Selection & Implementation
Which eTMF solution is right for you? Ensure an orderly transition with a stable foundation of detailed processes, whether transitioning from paper or between two eTMF systems.
TMF Reference Model Implementation
Establish clear expectations among all stakeholders with accurate indexing of documents within the TMF Reference Model framework.
Document Filing &
Indexing
Eliminate document handling latency by engaging LMK's team of TMF professionals to ensure your TMF is inspection ready upon closeout.
Training & Stakeholder
Engagement
Training and Stakeholder Engagement are the cornerstones of every optimally functioning TMF department. Our TMF Professionals can help you reinvigorate your team's approach to managing every Trial Master File.
Metrics Driven Process
Improvement
Develop metrics (per Metrics Champion Consortium guidelines) to assess the completeness and quality of your TMF on an ongoing basis.
Software’s Supported
