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. Whit its inherent integration with 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’s 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

News 19th September 2023

What is the difference between CTMS and EDC?

Clinical trials are a crucial component of medical research, playing a pivotal role in advancing healthcare treatments and therapies. Over the years, tools like Clinical ...

Learn More