ImproWise for Sponsors
Empowering Sponsors to Achieve Clinical Trial Success with Ease.
Accelerate Your Clinical Trials Approval with ImproWise
Top Reasons Why ImproWise -
CTMS + CDMS Works Best For Sponsors
Unified Platform
Improwise provides a unified platform that integrates Clinical Trial Management System (CTMS) and Clinical Data Management System (CDMS) functionalities, offering sponsors a single solution to manage all aspects of their clinical trials seamlessly.
Customizable Solutions
With Improwise, sponsors have the flexibility to customize their solutions according to their specific requirements. From study setup to data collection and analysis, sponsors can tailor the platform to meet their unique needs and preferences.
Ease of Use
Improwise features an intuitive and user-friendly interface that makes it easy for sponsors to navigate and utilize the platform effectively. With minimal training required, sponsors can quickly adapt to the system and maximize their productivity.
Comprehensive Study Oversight
Sponsors can gain comprehensive oversight of their clinical trials with Improwise's advanced monitoring and reporting capabilities. From tracking study milestones to monitoring site activities and subject enrollment, sponsors have access to real-time insights to make informed decisions.
Efficient Data Management
Improwise streamlines data management processes, allowing sponsors to collect, clean, and analyze clinical trial data efficiently. With built-in validation checks and data reconciliation features, sponsors can ensure data accuracy and integrity throughout the study lifecycle.
Regulatory Compliance
Improwise is designed to meet regulatory compliance standards, including FDA 21 CFR Part 11 and GDPR requirements. Sponsors can trust that their data is secure and compliant with regulatory guidelines, reducing the risk of non-compliance issues.
Collaborative Workflows
Improwise facilitates seamless collaboration among sponsors, investigators, and study teams. With features such as document sharing, task assignment, and electronic signatures, sponsors can streamline communication and workflow management across all stakeholders.
Scalable Solutions
Whether managing a single clinical trial or a portfolio of studies, Improwise offers scalable solutions that can adapt to the evolving needs of sponsors. From small biotech startups to large pharmaceutical companies, Improwise can accommodate organizations of all sizes.
Cost-Effective
Improwise offers cost-effective solutions that provide sponsors with value for their investment. With flexible pricing models and customizable packages, sponsors can choose the plan that best fits their budget and requirements.
Dedicated Support
Improwise provides dedicated customer support to assist sponsors every step of the way. From implementation and training to ongoing support and maintenance, sponsors can rely on Improwise to provide expert assistance and guidance whenever needed.
Improwise features for Sponsors
Study Startup and Oversight
Site and Contact Import
Simplify the process of importing sites and contacts by leveraging built-in templates, ensuring quick and accurate data entry to kickstart your study setup.
Comprehensive Startup Tracker
Utilize Improwise's comprehensive startup tracker, which comes ready to use out of the box. Customize the tracker by adding or removing columns, and utilize search, sort, and filter functionalities to identify and address study delays effectively.
Refined Study Milestones
Refine study milestones with ease, adjusting start/end dates and dependencies as needed. Visualize study progress and prioritize efforts using chart and dashboard views tailored to your specific requirements.
Site Contact Management
Manage site contact records seamlessly within Improwise, ensuring clear communication channels and accurate information regarding study roles, IP and supply shipment addresses, and CRA-site associations.
Action Item Tracking
Assign and track action items effortlessly, facilitating efficient collaboration and ensuring timely completion of tasks. Receive in-application and email alerts to stay informed about pending action items and deadlines.
ImproWise simplifies study startup and oversight with tools for importing sites and contacts, customizable startup trackers, and refined study milestone management. Streamline site contact management, track action items efficiently, and visualize progress with tailored dashboards and alerts.
Site Monitoring & Electronic Visit Reports
Standard EVR Templates
Establish standard EVR templates tailored to your team's and CRO's needs. Customize templates with Q&A sections, integrated tables for action items and protocol deviations, and inclusion of completion instructions for consistent reporting across CRA authors.
Template Setup Ease
Easily set up EVR templates within Improwise, leveraging intuitive features to create comprehensive templates that meet your study requirements.
Immediate Template Association
Associate final EVR templates with specific studies for immediate use, ensuring seamless integration into your monitoring processes.
Authorized Reviewers
Specify team members authorized to review and approve EVRs, streamlining the approval process and ensuring accountability.
Built-in Workflows and Alerts
Utilize built-in EVR workflows and alerts to streamline EVR drafting through final approval, ensuring timely submission and adherence to study timelines.
Site Trend Assessment
Assess site trends for protocol deviations, enrollment, and screen failures with comprehensive reporting and visualization tools, enabling proactive intervention and study optimization.
Access to Final EVRs
Easily access final approved EVRs and associated attachments in the documents folder, organized by site and visit for convenient reference and audit trail purposes.
Document Management
Standardized Views and Reports
Utilize standard views, exports, and reports to prioritize documents essential for site activation, IRB/EC submission, and study closure, streamlining document management processes.
TMF Reconciliation
Perform TMF reconciliation activities seamlessly using built-in tracking features, ensuring compliance and accuracy throughout the study duration.
Comprehensive Tracking
Quickly and consistently track document status, version, date, expiration date, and expiry status, enabling efficient management of document lifecycle.
Consistent Handling of Amendments
Manage protocol amendments or country-specific items consistently across participating sites, maintaining compliance and uniformity.
Efficient Document Handling
Post documents via single or multi-file upload, with the option to download the full TMF as a zip file for easy accessibility and sharing.
Access to Final EVRs
View final e-signed electronic visit reports and attachments within the site-specific folder, ensuring comprehensive documentation and audit trail.
Financial Management
Flexible Payment Tracking
Track data and visit completion status to determine full and partial payments. Utilize side-by-side comparison of subject visit detail and contract detail for a comprehensive assessment of payments due.
Detailed Invoice Generation
Utilize the built-in invoice generation feature to create detailed invoices by site, incorporating fixed and subject fees. These invoices accompany payments, providing clarity and accountability in financial transactions.
Comprehensive Tracking
Track invoice and payment progress by site and study, facilitating efficient management of financial activities. Run CTMS finance reports for one or more studies to gain insights into financial performance and compliance.
Subject Management and Integration
Detailed Subject Tracking
Manage key dates such as informed consent form (ICF) signature, screening, randomization, enrollment, and completion dates, providing a comprehensive overview of subject progress throughout the study lifecycle.
Protocol Deviation Assessment
Assess and triage protocol deviations reported via electronic visit reports (EVRs), data reviews, and other sources, allowing for timely intervention and corrective actions to maintain study integrity.
Comprehensive Visit Tracking
Track and trend screen failures, compliance with protocol visit windows, and completion of protocol-required activities, enabling proactive management of subject visits and study milestones.
Flexible Visit Schedule Management
Efficiently manage multiple protocol visit schedules due to protocol amendments, cohort studies, or complicated study designs, ensuring accurate scheduling and execution of study activities.
Seamless EDC Integration
Establish EDC integrations within Improwise to populate subject records, visit details, and support site payment activities, facilitating seamless data exchange and enhancing operational efficiency.
Reporting, Exporting, and Dashboards
Flexible Data Exports
Utilize exports within specific tabs and views to extract data in common formats, including Excel, facilitating easy analysis and sharing of information across teams.
Comprehensive Dashboards
Access interactive dashboards that provide visualizations for critical aspects such as site selection, startup progress, and recruitment efforts, enabling stakeholders to monitor key performance indicators at a glance.
Standard CTMS Reports
Run standard CTMS reports with performance metrics across studies, including site and team rosters, study and site planning activities, calendar and visit tracking, documents, subjects, and financial details, ensuring comprehensive oversight of study operations.
Customizable Reports
Customize CTMS reports to tailor them to specific needs, such as adding additional fields, adjusting display orders, and meeting cross-study reporting requirements, providing flexibility and versatility in data analysis.
