SOLUTIONS > CLINICAL MANAGEMENT

Clinical Management

Streamline clinical trials with the Dot Compliance clinical management solution

Optimize clinical trials with a modern solution

Biotechnology and pharmaceutical organizations need an efficient solution for clinical data management that allows them to holistically manage data, documentation, and regulatory activities across the different clinical stages.

Simplify Clinical Trial Processes

Clinical trials are one of the most complex and highly regulated phases of drug development. Dot Compliance simplifies management, planning, documentation, and reporting by connecting all trial activities in one compliant system. This unified approach reduces administrative effort, improves accuracy, and accelerates every stage of the clinical process—from study setup to closeout.

Drive Innovation

Digital solutions streamline how organizations manage documents, tasks, quality events, audits, and training throughout the clinical trial lifecycle. Automated workflows ensure all activities are executed consistently and in compliance with GxP and ICH guidelines. With seamless tracking and centralized reporting, teams can focus on advancing research, improving data integrity, and driving innovation that leads to faster, safer drug development.

Gain Greater Visibility

Real-time insights give sponsors and CROs a complete view of trial progress, milestones, and performance indicators. Dashboards and analytics highlight potential risks or delays early, supporting proactive decision-making and resource management. This visibility ensures studies stay on schedule, data remains reliable, and compliance is maintained across all trial sites.

Accelerate development, meet compliance, and streamline collaboration with Dot Compliance

Seamlessly manage and track the entire clinical research and trial process with Dot Compliance’s clinical trial management software (CTMS) combined with the eQMS. Ensure easy access and collaboration of all parties to study information, ETMF (Electronic Trial Master Files), clinical documents, and tasks.

Features and Benefits

Real-time visibility

One centralized platform that provides insight into clinical trials and harmonizes processes and optimized efficiencies.

Ensure good clinical practices (GCP)

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

Document management

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

Comprehensive trial master file (TMF)

TMF document management in accordance with the Drug Information Asociation (DIA) TMF reference model from initial stages until study closeout.

End-to-end management

Management of clinical site initiation process, including communication with the study team, site contacts, and patients (blinded or un-blinded).

Electronic submission and tracking

Automated submission management and tracking of submissions and related correspondence and tasks to site Institutional Review Boards (IRBs).

Quality event management

Efficient management of deviations and clinical study quality events, including impact/risk assessment, root cause analysis investigations, and initiation of CAPA.

The eQMS that keeps you one step ahead

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast – and to give you the insights to drive quality efficiently.