Clinical Management
Simplify Studies with Streamlined and Optimized Clinical Trial Management.
Dot Compliance’s Clinical solution combines Clinical Trial Management Software (CTMS) with QMS to optimize clinical documentation, quality and compliance. Risk is reduced and communications between sponsors, Contract Research Organizations (CROs)and sites are streamlined to help increase visibility into the clinical trial process.
THE CHALLENGE
Complex, Resource Intensive Processes
Clinical trials are one of the most complex and often cumbersome aspects of the drug development and manufacturing process. Organizations must manage, plan, document, and report each and every step.
The Need for Innovation
Paper based and legacy solutions no longer are capable of efficiently handling the myriad of documents, activities, tasks, quality events, audits and training that must be managed, tracked and reported throughout the life of a clinical trial.
THE SOLUTION
Accelerate development, maintain compliance, and streamline collaboration
Seamlessly manage and track the entire clinical research and trial process with a centralized solution. Ensure easy access and collaboration of all parties to study information, ETMF (Electronic Trial Master Files), clinical documents, and tasks.
PROCESSES COVERED
- Product registration
- Dossier file/Binders (document and binder)
- Registration/submission
- Variation Management (change management)
- Renewal management
- Regulatory correspondence management
- Regulatory commitment tracking
FEATURES & BENEFITS
A Controlled Process
- Comprehensive Trial Master File (TMF) document management in accordance with DIA model structure from initial stages until study closeout.
- Management of clinical site initiation process including the communication with study team,site contacts and patients (blinded or un-blinded).
- Automated submission management and tracking of submissions and related correspondence and tasks to site Institutional Review Boards (IRBs).
- Robust quality event management of deviations and clinical study quality events including impact/risk assessment, root cause analysis investigations, and initiation of CAPA.
Experience ready to use QMS
DATASHEET
Dot Compliance Clinical Management Solution
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