CTMS

The CTMS (Clinical Trial Management System) by Delve Health is a software solution designed to streamline and optimize the management of clinical trials. It provides a centralized platform for planning, executing, and monitoring all aspects of a clinical trial, making it suitable for companies of various sizes, from small startups to large pharmaceutical companies and academic research institutions. This system is utilized by professionals and industries, including Clinical Research Organizations (CROs), Pharmaceutical and Biotechnology Companies, Academic Research Institutions, Contract Research Organizations (CROs), and Medical Device Companies.

Key Features

Wearable Devices in Clinical Trials: According to the vendor, the system enables patient monitoring, surveillance, screening, diagnosis, and treatment assistance through wearable devices and biosensors. This feature facilitates real-time physiological feedback for assessing treatment efficiency and incorporates artificial intelligence (AI) in software solutions for wearables and remote biosensors. It also supports remote monitoring of patients, potentially reducing the need for frequent site visits.

Patient eConsent: The vendor claims that the system automates the patient enrollment process through digital consent forms, reducing errors in informed consent and ensuring compliance with multiple government regulations. This feature is configurable for multiple languages, increasing accessibility for diverse patient populations. It provides options for hand signature or video consent, utilizing facial recognition for enhanced privacy and security.

ePRO / eCOA (Electronic Patient-Reported Outcomes / Electronic Clinical Outcome Assessments): According to the vendor, the system allows for the electronic collection of patient-reported outcomes, leading to potentially higher quality data. This feature enables real-time tracking of symptoms and treatment responses, improving patient compliance and engagement by utilizing mobile apps and wearable devices. It aims to enhance data accuracy and reduce variability compared to traditional paper diaries.

Patient Concierge Services: The vendor states that the system serves as a single point of contact to help patients navigate the complexity of clinical trials. This feature provides support for comprehension, participation logistics, and technologies. It aims to increase patient engagement and retention through proactive check-ins and data entry assistance. It also offers services such as in-home care requests, remote patient monitoring, and shipping services, with the goal of improving the patient experience.

Patient Retention in Clinical Trials: According to the vendor, the system focuses on patient compliance and retention to ensure successful study outcomes. This feature utilizes technology, such as mobile apps, SMS, and automated phone calls, to improve patient engagement. It offers in-home services and remote patient monitoring to potentially reduce patient burden and increase compliance. It alerts investigators in real-time to address non-compliance issues promptly.

Randomization & Trial Supply Management: The vendor claims that the system optimizes randomization processes and manages clinical trial supply. This feature supports various randomization methods and stratification options. It integrates with third-party vendors, such as EDC (Electronic Data Capture) systems. It provides oversight dashboards, interactive reports, and real-time supply status tracking.