CLINICAL TRIAL MANAGEMENT SYSTEM

Accelerate your trial and ensure data integrity
EFFICIENCY AND OVERSIGHT

ACCESS TO ACCURATE, UP-TO-DATE, STUDY INFORMATION

EvidentIQ’s CTMS platform streamlines and centralizes the conduct and management of clinical studies in a single, cost-effective system. Inherent integration with the EDC, eCOA, and eTMF, our CTMS offers an enterprise solution to help you make informed and timely decisions.

The comprehensive feature set includes study, site and vendor management, eMonitoring, Investigator payments, product management, safety management and a powerful reporting tool,

With the integrated functions to support all the steps in the clinical trial process, intuitive user interface, and an open architecture to allow users and study administrators to customize their own forms and modules, EvidentIQ’s CTMS is the perfect solution to meet your study and business goals.

BENEFITS

IMPROVE STUDY AND SITE MANAGEMENT

Get More Insight Into Your Clinical Trial Management

EvidentIQ CTMS facilitates the end-to-end management of clinical trials. The software allows sponsors to be more efficient, make better decisions, ensure compliance, select investigators, monitor patient recruitment and manage finances. Our CTMS includes comprehensive directories to manage site personnel (investigators, sub-investigators, study coordinators, pharmacists) and entities (sites, competent authorities, CROs, suppliers).

FACILITATE SITE PAYMENTS

Improve site payments cycle time

  • Payments are stored and tracked in our payment module
  • Support multiple currencies for your global trials
  • Payment Requests and Payment letters to the Investigators can be printed and submitted.
  • Detailed history of what was paid is stored for easy reference
  • Support tracking accruals
  • Identify the amount of payment for each eligible eCRF
  • Track what was paid prior to ensure no double payments
BETTER INSIGHTS

Customizable dashboards

  • Include EDC, CTMS, and/or eTMF information
  • Drill down capabilities = manage workflow and use as tasklists
  • Different dashboards for different role types = customers have control over who sees what information
  • Dashboards can be global (across studies) or study-specific

FEATURES

General

  • CTMS is fully integrated with the EDC, eTMF, and eCOA
  • Role-based security management
  • Full audit trail accessible (via right click) on all fields
  • Customizable and extendible data collection feature
  • Email notifications can be generated against any data within the system
  • Custom navigation through buttons, reports and tasklists

Study Management

  • Manage and track enrollment projections.
  • Forecast data entry volumes for actual and projected subjects
  • Track protocol submissions to multiple regulatory authorities
  • Vendor Management
  • Send global study communications
  • Track Study Milestones
  • Study and Site level issue and action item management

Site Selection / Management

  • Global site and site personnel repository
  • Manage site selection process
  • Support for multiple addresses for sites/site personnel.
  • Track Site IRB/EC submissions
  • Link to eTMF for easy documentation collection and tracking.

Customizable Dashboards

  • Customizable, interchangeable dashboards pulling data from the CTMS, EDC, and eTMF data
  • Drill down capabilities promotes use to manage workflows and use as tasklists
  • Dashboards are study specific and may be role based

Monitoring

  • Complete monitoring report electronically, route for review and signature, before automatically pushing the signed report to the eTMF.
  • Track issues and action items; push to site portal to facilitate resolution
  • Compile and email post-visit letters via CTMS.

Investigator Payments

  • Customizable rule-based investigator compensation system, including CRF and ad-hoc payments
  • Payment History Reporting
  • Check Request and Payment Letter generation

Product Management

  • Manage Drug and Device accountability including shipment, receipt, use and return
  • Interface between CRF and product tracking automates inventory management to reflect product usage and allows for accurate status of site inventory
  • Support for Lot # or Serial # based product
  • Product Disposition and Inventory reports

Administrative Forms

  • Create custom screens to collect CTMS specific data
  • Collect data beyond CRFs, including delegation logs, product logs, core lab and training records
  • Upload and attach files to CRFs
  • Build your own tools/modules

Safety Management

  • Manage safety within the CTMS system
  • Custom screens to collect safety data per your SOPs.
  • Attach documents to safety record (source records, product records, etc).
  • Route events within the system for review, coding, medical review, follow-up
  • Supports MedDRA and/or custom coding
  • Output reports and metrics.

Reporting

  • Not only can you collect your data, but you can get it out, too – in multiple formats. Clindex® has built-in advanced reporting tools to help you run ad hoc queries against your data or you can write your own reports to be accessible on-demand by your study team and/or sites. Our drill-down technology enables users to open eCRFs directly from report output.
  • Built-in and customizable detailed reporting tools – more than just lists
  • Over 200 standard system reports
  • Supports advanced reporting with nested reports, grouping, images and complex layouts
  • Reports can be used to drive interactive task lists
  • Drill down so Queries, CRFs, Documents, Monitoring Issues can all be opened automatically directly from a report that is retrieving data identifying the specific item
  • Intelligent report viewer allows filtering, sorting, descriptive statistics and graphing.
  • Direct generation of SAS or SPSS files from any report or SQL query dataset. Includes all data dictionary information
  • Automatically save reports to specific directories or email reports as attachments based on pre-defined schedule.

Investigator Compensation

  • Customizable rule-based investigator compensation system, including CRF and ad-hoc payments
  • Payment History Reporting
  • Check Request and Payment Letter generation
  • Generate milestone payments or invoice based payment

Supplemental Fields / Custom Screens

  • Extend data collected about any entity (e.g., site, study, protocol) with custom fields including document links, URLs, Custom Screens
  • Create custom screens to collect CTMS specific data
  • Can be set up by end users
“I am extremely pleased at how well this software has served us in the last year (we just had the first year anniversary of launching our trial last week). Although credit certainly goes to my staff for learning so quickly, it must also go to your company for creating this user friendly software that a non-initiate was able to get up and running in a few months with no major glitches in 12 months! Thanks for a superior product.”
Taraz Samandari
CDC, US Department Health and Services
RESOURCES

How to Select CTMS that will Positively Impact the Quality of ...

The global usage of the clinical trial management system (CTMS) is increasing thanks to its outcome’s significance and efficiency. It lessens the cost of the ...

Learn More

Newly formed data science group created from XClinical, Carenity, and Fortress Medical, to ...

MUNICH, Germany, Feb. 9th, 2021 – The newly formed life science group that resulted from the merger ...

Learn More

How to Select CTMS that will Positively Impact the ...

The global usage of the clinical trial management system (CTMS) is increasing thanks to its ...

Learn More

Get a Demo

Let us show you how we can help you and your business

Schedule a Meeting

Let’s start a new project together

Request for Proposal

Discover a solution tailored to your needs
TRUSTED BY THE WORLD'S LEADING COMPANIES