ImproWise

ImproWise is a 100% web-based clinical trial management platform developed by Core Clinical Services, a healthcare technology company founded in 2001. The platform combines Clinical Trial Management System (CTMS) and Clinical Data Management System (CDMS) functionality into a single integrated solution, also incorporating EDC, CTBM, CTPM, eTMF, ePRO, and RBACS modules. It is designed for sponsors, CROs, trial sites, clinics, hospitals, and independent medical examiners involved in clinical research.

The platform is HIPAA compliant, supports multi-trial and multi-site handling through a single login, and is built to accommodate users at all levels — including data managers, data entry specialists, site staff, investigators, and regulatory affairs professionals — without requiring programming knowledge for most configuration tasks.

Clinical Data Management (CDM) Capabilities

• Provides a single source of truth for all clinical trial data with validated data integrity.
• Automatically reconciles data discrepancies to maintain accuracy and consistency.
• Ensures complete traceability of all trial data to support compliance and oversight.
• Simplifies data handling processes to reduce errors and improve efficiency.

Clinical Trial Management System (CTMS) Capabilities

• Manages the full clinical trial lifecycle from planning through close-out.
• Provides real-time visibility into trial status to support faster decision-making.
• Supports study planning, budgeting, and day-to-day trial management.
• Automates workflows to reduce costs and improve operational efficiency.
• Includes analytics and reporting tools for data-driven insights.

Clinical Trial Budget Management (CTBM)

• Provides oversight of clinical trial finances, including cost prediction and resource allocation.
• Supports accurate management and adjustment of study budgets.
• Tracks site budgets and payments to streamline financial operations.

Electronic Trial Master File (eTMF)

• Stores all clinical trial documents in a secure, cloud-based repository.
• Manages study protocols, informed consent forms, investigator brochures, and monitoring reports in one location.
• Provides centralized access and document sharing across teams.

Customization and Reporting

• Supports customization of workflows, fields, and features to fit specific trial requirements with minimal programming effort.
• Allows flexible configuration of settings to align with study protocols and compliance standards.
• Enables dynamic eCRF design, often completable within a few days.
• Offers customizable report templates, dynamic data visualization using charts and graphs, real-time data access, and advanced filtering and sorting options.

Platform Features and Technical Characteristics

• Fully web-based and mobile-responsive, accessible from any device without a native app.
• Dynamic, database-driven architecture requiring minimal customization across different trials.
• User-friendly query builder accessible to non-technical staff including CRCs, doctors, and principal investigators.
• Comprehensive audit trail covering every data element entered or changed by CRCs, QA personnel, or principal investigators.
• Supports multi-trial and multi-site management through a single login.
• HIPAA compliant with secure web-based access ensuring data privacy.

Reported Platform Benefits

• Claims cost savings of over 50% compared to standard operational costs by reducing delays and protocol deviations.
• Accelerates trial workflows, data analysis, and regulatory submission to support faster time-to-market.
• Centralizes operations and unifies data management across CTMS and CDM in a single platform.
• Minimizes data errors and supports adherence to regulatory standards.
• Scales to support trial expansion and adapts to unique trial requirements.
• Provides real-time monitoring and reporting for informed decision-making.

Services Offered by Core Clinical Services

• Clinical Trials Management Solutions via web platform
• Clinical Data Management
• Clinical Notes and Documentation Compliance Audits
• Healthcare Data Analytics
• Plan of Care Preparation
• Medical Records Management
• Healthcare IT Consulting Services
• Provision of trained and experienced Clinical Data Management personnel

Core Clinical Services is headquartered in Burke, Virginia, USA, with an additional office in Pune, India. The company reports serving over 100 clients, with more than 1.9 million clinical hours invested and over 1.5 million patient cases handled. ImproWise is positioned for use by pharma companies, CROs, trial sites, clinics, and medico-legal service providers.