Protocol Manager

Clinical trial management and tracking for drugs, devices, biologics, and vaccines across all development phases.

Overview

Protocol Manager is a configurable, off-the-shelf Clinical Trials Management System (CTMS) developed by Atlant Systems. It is designed to support clinical operations teams managing global trials across drugs, devices, biologics, and vaccines at all phases of development. When implemented alongside appropriate Standard Operating Procedures, Protocol Manager supports compliance with FDA 21 CFR Part 11 regulations.

Protocol Manager is intended for organizations experiencing growing complexity in trial management — including increasing numbers of trials, sites, and subjects, difficulties managing regulatory documents across international boundaries, and challenges with investigator payments, site initiation, and contractor invoicing. It functions as a tracking tool and database for trial information and metrics, and is not a replacement for Electronic Data Capture (EDC) systems, Clinical Data Management Systems (CDMS), or hands-on study management.

What Protocol Manager Tracks and Manages

Subject visits and monitoring visits
Regulatory and trial documents
Investigator and contractor payments
Inventory management
Patient and subject cohort management
Site information and site contracts
Time and expense reporting

Features and Capabilities

Online and offline use modes
Available as hosted or licensed deployment
Email alerts and notifications
21 CFR Part 11 compliance support
Industry-standard security
Document and letter templates for cross-trial consistency
Business development module
Realtime site portal
Wide range of reporting options and metric measurements
Automation supporting cross-trial and cross-program consistency

Integration

Supports Web Services technology for integration with EDC and IVRS products
For systems that do not support Web Services, integration is available via an export/import mechanism

Deployment Options

Microsoft .NET Platform
Cloud Platform (free trial available)
IBM Lotus Notes Platform

Protocol Manager is available for demonstration on request and can be deployed across multiple platforms to suit different organizational infrastructure requirements.