Medidata DCT logo

Medidata DCT

by Medidata Solutionsmedidata.com
VISIT OFFICIAL WEBSITE →
Disclaimer: This page is an independent third-party listing and is not affiliated with, sponsored by, or endorsed by Medidata DCT or Medidata Solutions. All product names, logos, and brands are property of their respective owners.

OVERVIEW

The industry's most comprehensive, unified, and flexible end-to-end technology solution for decentralizing clinical trials.

The Medidata Decentralized Clinical Trials (DCT) Program is a comprehensive suite of unified, secure technologies designed to enable full or hybrid decentralization of clinical trials for sponsors and Contract Research Organizations (CROs). Built directly within the Medidata Clinical Cloud platform, it eliminates the need for complex integrations with multiple point solutions, providing a single source of truth for all trial data.

Key Benefits:

  • Flexibility with Trial Dial™: Allows sponsors to customize their study design to be 100% site-based, 100% virtual, or any hybrid model in between, optimizing physical and virtual interactions.
  • Enhanced Patient Experience: Reduces patient burden and increases trial accessibility by allowing participation from anywhere, at any time, using their own devices (BYOD).
  • Digital Oversight: Enables centralized, remote, and risk-based monitoring with advanced analytics, improving clinical decision-making and ensuring patient safety and data quality.

Main Features & Capabilities:

  • myMedidata Patient Portal: A single-destination, web-based portal for virtual patient enrollment and participation in pre-, during, and post-trial activities, including myMedidata Registries.
  • Direct-to-Patient (DtP) Services: Utilizes Rave RTSM to manage and track the life cycle of Investigational Product (IP) shipments directly to a patient's home.
  • Patient Cloud Suite: Includes eConsent, eCOA (electronic Clinical Outcome Assessment), and Sensor Cloud for capturing data from wearables and patient-owned devices.
  • Digital Oversight Tools: Includes Medidata Detect and Medidata Risk Management for risk identification, monitoring, and mitigation. [cite: 15 in 2nd search]
  • Turnkey DCT Network: Partnership with Circuit Clinical provides access to a national network of DCT sites and MD Prescreen recruitment support. [cite: 19 in 2nd search]

RATING & STATS

User Rating
4.6/5.0
49 reviews
Customers
1,000+
Founded
1999

KEY FEATURES

  • Unified End-to-End DCT Platform
  • myMedidata Patient Portal (Virtual Participation)
  • Direct-to-Patient (DtP) IP/Drug Delivery
  • Digital Oversight and Risk-Based Monitoring (RBM)
  • Trial Dial™ for Hybrid Study Design
  • eConsent and eCOA (Electronic Clinical Outcome Assessment)
  • Sensor Cloud and BYOD Data Capture

PRICING

Model: enterprise
Pricing is not publicly disclosed. It is an enterprise-level subscription model, likely based on the scope of the clinical trial, modules used (e.g., Rave EDC, myMedidata, Rave RTSM), and patient/site volume.

TECHNICAL DETAILS

Deployment: saas, cloud
Platforms: web, ios, android
📱 Mobile Apps🔌 API Available

USE CASES

Decentralized Clinical Trials (DCTs)Hybrid Clinical TrialsPatient Recruitment and EngagementRemote Monitoring and Data Quality OversightDirect-to-Patient Drug Supply Management

INTEGRATIONS

Circuit Clinical (DCT Network/Recruitment)Cogstate (CNS Assessment)Click Therapeutics (Digital Therapeutics)Non-Medidata Clinical Data Sources

COMPLIANCE & SECURITY

Compliance:
ISO 27001ISO 27701SOC 2 Type IIGDPRFDA 21 CFR Part 11ICH E6 (R2/R3)EU GMP Annex 11
Security Features:
  • 🔒SSO
  • 🔒2FA
  • 🔒Audit Trail
  • 🔒Data Governance
  • 🔒Encryption

SUPPORT & IMPLEMENTATION

Support: email, phone, training
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Single, unified platform for all DCT components (eliminates point-solution integration).
  • +High flexibility with Trial Dial™ to support hybrid and fully virtual trials.
  • +Robust compliance and security certifications (e.g., SOC 2, ISO, FDA 21 CFR Part 11).
  • +Strong focus on patient-centricity with myMedidata and BYOD support.
  • +Market leader with extensive experience and large user base.
✗ Cons:
  • -Pricing is not publicly transparent (enterprise model).
  • -Report downloading can sometimes be slow (based on general Rave EDC reviews).
  • -Issue resolution/rectification can take a long time (based on general Rave EDC reviews).

ABOUT MEDIDATA SOLUTIONS

Other software by Medidata Solutions:
Medidata RTSM (Clinical Development SoftwareRandomization and trial supply management)
Medidata Rave EDC (Clinical Development SoftwareElectronic data capture (EDC))