ImproWise For CROs
Enabling CROS to Deliver Precision and Speed in Clinical Trials.
Partner with the Improwise platform and enable your organization
Top reasons why Improwise -
CTMS/ CDMS works BEST for CROs.
Dynamic Pricing for Small and Mid-Sized Clinical Research Organizations (CROs)
Tailored for the needs of small and midsize CROs, Improwise offers a Clinical Trial Management System (CTMS) with pricing that adjusts to your business demands. Our flexible month-to-month pricing structure allows you to scale costs based on user numbers, ensuring you pay for precisely what you need as your trial portfolio expands or contracts.
Scalable CTMS Designed for Small and Mid-Sized CROs
Improwise's software is built to grow with your organization. As part of the unified Clinical platform, it can be gradually adopted as required. Enjoy fast implementation to kickstart your operations quickly, starting small with clinical feasibility and planning tools. Plus, integration with electronic data capture systems saves valuable time. Improwise platforms cover site payments, and monitoring, and even offer world-class safety monitoring tools for reporting Sudden Unexpected Adverse Reactions (SUSAR).
Intuitive and User-Friendly CTMS
Improwise's platforms boast an intuitive interface designed to cater to all stakeholders involved in study conduct. With role-based access and intuitive dashboards, it ensures a unified experience tailored to individual needs. Simplify complex clinical trials without compromising efficiency.
CTMS Optimized for Speed and Efficiency
With ImproWise, you can streamline startup processes and get your clinical trials up and running swiftly. Conduct feasibility studies, identify high-performing sites, and manage regulatory requirements efficiently to meet tight deadlines and maintain high-quality standards.
Working Smarter with Improwise's CTMS
Improwise's platforms automate critical activities throughout the clinical trial lifecycle, from study planning to site assessments and investigator selection. With support for multiple templates and a unified view of trial activities, it enables study teams to stay aligned and on schedule. Embrace efficiency and eliminate the need for micromanagement with our proven automated software solution.
Improwise features for CROs
Study Startup and Oversight
Integrated Site Starting Tracker
Our integrated tracker allows you to effortlessly track site starting activity, from site selection to enrollment.
Customisable Startup Tracker
You can effortlessly tailor the startup tracker to your team's requirements, Sponsor requirements, or research needs, just as you would with Excel.
Cross-Study uniformity
Use customized startup trackers in different studies to maintain uniformity among your Site Start-Up (SSU) teams.
Study Milestones
Use study milestones to track dates and dependencies, as well as visualize progress using charts and dashboards.
Site Essential Document Management
Easily manage site essential documents using the eTMF architecture and follow the status of site startup document packets.
Action Items and Notifications
Prioritise team tasks and get alerts for critical items to ensure effective team communication and timely task completion.
Document Management
Multiple TMF Models
Choose from standard TMF models such as the DIA reference model, or the Improwise model, or create a custom eTMF model tailored to your specific needs.
Flexible Document Tracking
Utilize advanced document tracking features and file upload capabilities to streamline document management processes.
Customizable Document Sets
Set essential documents required for activation, study closure, and items requiring Ethical Committee (EC) approval, ensuring compliance with regulatory requirements.
Comprehensive Document Tracking
Track document status, version, date, expiration date, and status consistently and efficiently within the system.
Protocol Amendments Management
Easily manage protocol amendments and country-specific document requirements to maintain regulatory compliance.
Reusable TMF Structures
Reuse custom TMF structures and definitions across multiple studies for enhanced consistency and efficiency.
Efficient Document Handling
Post documents via single or multi-file upload options and utilize zip download functionality for streamlined Sponsor TMF return at the end of the study.
Customizable Folder Structure
Add and order folders to support company documents, team documents, and study or site-specific items, enhancing organization and accessibility.
Monitoring Activities
Site Visit Management
Calendar site visits, view team member schedules, and assess team resourcing across multiple studies effortlessly.
Visit Report Management
From drafting to approval, manage visit report completion progress seamlessly. Utilize Visit Report Metrics reports to ensure adherence to monitoring plans.
Document Tracking
Access site documents, track collection/review/approval status, and perform ongoing Trial Master File (TMF) reconciliation with ease.
Prioritization and Alerts
Prioritize items required for study activation and utilize document expiration alerts to proactively manage renewals, ensuring compliance at all times.
Site Personnel Management
Easily manage site personnel contacts, including supply addresses, study roles, and contact details, in one centralized location for improved efficiency.
Action Item Tracking
View comprehensive action items across teams and studies, allowing for proactive management of tasks. Trend protocol deviations across sites to identify patterns and take corrective actions as needed.
Electronic Visit Reports (EVRs)
Template Design
Design EVR templates quickly and easily to meet Sponsor requirements or internal templates within the CTMS.
EVR Approvers
Specify appropriate EVR approvers and manage the authorization process seamlessly within the platform.
Author and Approve
Author and approve EVR reports directly within Improwise CTMS, ensuring efficient and timely completion.
Monitoring Plan Compliance
View outstanding reports and oversee completion metrics to ensure compliance with the monitoring plan.
Reminder and Workflow Alerts
Utilize reminder and workflow alerts to guide on-time approvals and streamline the approval process.
Customizable Templates
Customize EVR templates with CRA completion instructions, and Q&A sections, and specify responses as needed.
Table Integration
Build EVR templates using tables for action items, deviations, IP review, ICF and data review, SAEs, and screening and enrollment.
Attachment Support
Include confirmation and follow-up letters as attachments to facilitate review and approvals, enhancing document management efficiency.
Study Association
Associate final EVR templates to studies for immediate use, ensuring seamless integration with ongoing study activities.
Alert Notifications
Receive in-app and email alerts for EVR drafting through final approval, enabling proactive management of reports. Use alerts to manage due and nearly due reports for compliance with monitoring metrics.
Automatic Posting
Final approved e-signed reports and associated attachments are automatically posted in the eTMF, ensuring document traceability and regulatory compliance.
Subject Management
Recruitment Assessment
Assess study recruitment efforts against targets and trends, and identify screen failures and protocol deviations for proactive management.
Subject Details Tracking
Track subject details by visit, screening, enrollment/randomization, ET, and/or completion dates, ensuring accurate record-keeping and compliance.
Enrollment Management
Manage enrollment activities by cohort and protocol version, optimizing study enrollment processes for efficiency and accuracy.
Data Import Features
Utilize standard data import features to automate tracking needs, saving time and reducing manual data entry errors.
Visit Schedule Management
Manage visit schedule changes associated with protocol amendments and study design criteria, ensuring adherence to study protocols.
Protocol Compliance Oversight
Oversee subject compliance with protocol visit windows, completion of protocol procedures, and data entry requirements, enhancing study integrity and regulatory compliance.
Deviation Review
Review and triage protocol deviations arising from electronic visit reports, enabling timely corrective actions and protocol adherence.
EDC Integration
Integrate with Electronic Data Capture (EDC) systems to populate subject records, visit details, and support site payment activities, streamlining data management processes.
Customizable Tracking
Quickly customize the tracking view to support additional protocol-specific needs, ensuring flexibility and adaptability to study requirements.
Dashboards, CTMS Reports, and Exports
Study-Specific Data Exports
Export data in common formats including Excel, allowing for easy analysis and sharing of study-specific information.
Visual Dashboards
Gain insights at a glance with visualizations for site selection, startup progress, and recruitment efforts, enabling informed decision-making and progress tracking.
Standard CTMS Reports
Access standard CTMS reports that cover a wide range of areas including site and team rosters, study and site planning activities, calendar and visit tracking, documents, subjects, and financial details, ensuring comprehensive reporting capabilities.
Customizable Columns
Customize application views with custom columns, and seamlessly incorporate them into CTMS reports for tailored reporting that meets your specific needs.
