CTMS

Octalsoft CTMS (Clinical Trial Management System) is a clinical trial management platform designed to support the planning, execution, and oversight of clinical research. It is built for sponsors, contract research organizations (CROs), and site teams, and is intended to consolidate trial operations into a single system while maintaining compliance with global regulatory standards including 21 CFR Part 11, GCP, and GDPR.

The platform integrates with other components of the Octalsoft eClinical suite, including EDC, IWRS, and ePRO, and supports multi-site and global trial deployments. It offers configurable workflows, centralized document management, financial tracking, and real-time analytics across the trial lifecycle.

Centralized Trial Oversight

• Provides a unified dashboard consolidating trial timelines, milestones, and deliverables across all study activities.
• Delivers real-time alerts and analytics to support proactive risk management.
• Maintains operational consistency across global and multi-site deployments.

Study Planning and Setup

• Supports trial startup through configurable workflows.
• Digitizes protocol design, site selection, and budget forecasting.
• Tracks contracts, investigator payments, and resource allocation.
• Applies automated checks and validations to reduce manual errors.

Site and Subject Management

• Maintains detailed site profiles, staff credentials, and training records in a centralized system.
• Facilitates communication between sponsors, CROs, and sites.
• Tracks subject enrollment, visit schedules, and retention metrics.
• Supports compliance through centralized document management.

Financial Transparency and Control

• Automates budgeting, forecasting, and payment schedules.
• Tracks investigator grants, reimbursements, and site expenses.
• Supports financial reconciliation across multiple geographies and currencies.
• Maintains clear financial reporting trails to support audit readiness.

Real-Time Reporting and Analytics

• Generates customizable dashboards for trial progress and key performance indicators.
• Tracks recruitment, protocol deviations, and monitoring activity in real time.
• Supports visual analytics for data-driven decision-making.
• Provides secure shared insights to facilitate sponsor-CRO-site collaboration.

Role-Specific Benefits

• Sponsors: Centralized trial intelligence supports oversight, timeline management, and stakeholder collaboration.
• CROs: Supports management of multiple sponsor studies with consistency, and scales across regions and protocols.
• Site Teams: Provides tools for visit tracking, document management, and payment processing to reduce administrative workload.

Add-On Integrations

• Octalsoft EDC: Integrates for clinical data capture, cleaning, and management.
• Octalsoft ePRO: Supports remote patient-reported data capture directly within CTMS workflows.

Octalsoft CTMS is part of an all-in-one eClinical platform that covers planning, operations, data capture, and analytics. The system is designed to meet regulatory requirements including 21 CFR Part 11, GCP, and GDPR. Octalsoft provides personalized onboarding, 24/7 support, and ongoing optimization services alongside the platform.