SOLUTIONS > CLINICAL TRIAL MANAGEMENT

Clinical Trial Management

Streamline clinical trials with the Dot Compliance clinical trial 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 a critical yet complex part of drug development and manufacturing. Streamlined management, planning, documentation, and reporting can make every step more efficient.

Drive innovation

Digital solutions empower organizations to efficiently manage documents, tasks, quality events, audits, and training, ensuring seamless tracking and reporting throughout the clinical trial process.

Gain greater visibility

Gain insights into clinical trial progress and data to support better decision-making and proactive risk management.

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.

Smart solutions for life sciences companies at every stage

Meet the eQMS that evolves with you, from setting a foundation with core processes to the industry’s most sophisticated AI quality and compliance intelligence.