Clinical Management

Simplify Studies with Streamlined and Optimized Clinical Trial Management

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.

Real time visibility

One centralized platform that provides insight into clinical trials, and harmonizes processes and trial optimizes efficiencies.

Ensure GCP

Connect clinical operations and quality to ensure the quality and compliance of processes, data, and documentation.

Document control

Allowing users to organize, manage, and track documents, images, and other digital content necessary for conducting clinical trials.

One centralized platform that provides insight into clinical trials, and harmonizes processes and trial optimizes efficiencies.

Connect clinical operations and quality to ensure the quality and compliance of processes, data, and documentation.

Allowing users to organize, manage, and track documents, images, and other digital content necessary for conducting clinical trials.

Real time visibility

Ensure GCP

Document control

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

Explore Dot’s products

No matter what your quality and compliance needs are, we have a solution for you.

QMS Xpress Symbol

QMS Xpress

Set your eQMS foundation with a comprehensive set of ready to use core quality processes

Xpand

Compliance Xpand

Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas

Xact

Enterprise Xact

Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements