What is a CTMS? The Clinical Trial Management Key
Table of Contents Effective clinical trial management is critical to success in drug development. A clinical trial management system (CTMS) is an essential tool that
March 21, 2024
Reliable
Real-time information
Configurable
User-friendly
Offline functions
Traceability
Works in Mobile and Web devices
Vaccine-Tailored Version
Create eDiary and any other trial-specific forms in as little as 1-2 hours as per protocol specifications.
To activate additional modules such as Chat, eConsent, and Telehealth (Beta version). A way to enable hybrid or Decentralized Clinical Trials (DCT) when integrating TrialPal with Trial360 and EDC.
To enhance interoperability between site CTMS, EDCs, or any third-party application.
Easily set up vaccine clinical trial eDiary or surveillance forms for symptom monitoring, including subforms, grading, alerts, and AEs – SAEs real-time notifications to stakeholders, where sites can also act quickly upon receiving subject reports.
With the Trial Site app, physicians can manage reconciliations, and with Trial API, data is sent automatically to the eCRF or EDC system.
Value
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Diaries are used in clinical trials where investigators want to gather information after each vaccination or medication given. With this module, the information reported by patients is shared in real-time to enable site staff to know what is happening with each patient.
Quality control tools such as data validation built into the app minimize human error and increase accuracy.
With
Electronic Signature
No Internet
No Problem
The Surveillance module allows clinical trial participants to report symptoms, thus efficiently raising awareness of adverse events for the study site. It is ideal for surveillance studies where participants must report their health status periodically for long periods. This module is designed for an easy and friendly user experience. Report:
No Internet
No Problem
The convenient Chat module is designed to improve communication between the participants and the site. It provides all the tools of traceability and safety, ensuring that an audit trail of all conversations related to the study remains in our databases.
Site users can review the conversations related to study participants or legal representatives.
Benefits of the chat Module:
No Internet
No Problem
The TrialSite management console enables participant enrollment and set-up study protocol, forms, notifications, alerts, and reports. Get multiple views of the eCOA/ePRO data entry status, reporting performance analytics and data precision. Made agile study start-ups with the on-off architecture; this module interface is intuitive and requires low-burden implementation and support time.
Set-up and remote monitoring of:
What do
We Offer
The Interactive Multimedia Electronic Consent: Present all the informed consent information dynamically with multimedia assistance.
Benefits
Robust TrialPal API enhances interoperability between site CTMS, EDCs, or any other third-party application like Rave from Medidata.
Study Dashboard
Our TrialPal dashboards provide an overview of the trial status, with on-demand indicators such as symptomatology and intensity per patient, group, or site, as well as reports and visit completion.
E-Diary Dashboard
The dashboards allow detailed tracking of AE and SAE, and other key variables to make data-driven decisions throughout the study. The practical design makes it easier to do analytics and presentations.
Download the TrialPal Brochure
We studied the performance of a smartphone application-based participatory syndromic surveillance (PSS) system for collecting syndromic data (acute febrile illness [AFI] and acute gastroenteritis [AGE]) to detect dengue virus (DENV) and norovirus (NoV) on a cohort of children living in a low-resource and rural area of Guatemala.
Read the article “Performance of a Smartphone Application-Based Participatory Syndromic Surveillance System for Acute Febrile Illness and Acute Gastroenteritis in Rural Guatemala“ by D. Olson, Takeda Pharmaceuticals: Consultant, Grant recipient. R. Zambrano, Integra IT: Employee and Shareholder, Salary. S. Rodriguez-Castro, Integra IT: Employee and Shareholder, Salary. E. J. Asturias, Takeda Pharmaceuticals: Consultant and Grant Investigator, Grant recipient, at Oxford Academic.
FE known by site vs Blood sample collection
Clinical Trial: 935 subjects
Phase 2 Dengue Vaccine
Site: Cevaxin Panama
Affordable (accessible) for small and medium size Sites, CROs, and Sponsors
Real-time data for data-driven decisions
Faster start-up studies
Interoperability (integrations between own and third-party systems)
Validated and GCP-compliant
On-demand scalable architecture (per solutions, modules, and features)
Expertise in low and middle-income countries
Vaccine-exclusive features available
Around 70% of our clinical research experts are Latin American professionals with global experience
Table of Contents Effective clinical trial management is critical to success in drug development. A clinical trial management system (CTMS) is an essential tool that
Table of Contents What is electronic patient-reported outcomes (ePRO)? ePRO stands for “Electronic Patient-Reported Outcomes.” It is a tool that allows patients to record
Table of Contents The global eCOA market is poised for significant growth in the coming years. Grand View Research shows the market is expected to
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