Clinical Trial Management System (CTMS)

Leverages Microsoft Assets

Bioclinica CTMS is Microsoft Office-Smart. It allows you to leverage the Microsoft Office suite (SharePoint, Outlook, Excel, Word, Access and Project) to access, update and report on study data, as well as track and manage study activities securely and compliantly.

Bioclinica makes it easy to connect to clinical trial data through Outlook, export to Excel and collaborate in a secure way using direct connection to SharePoint. Bi-directional information exchange between Bioclinica and SharePoint and other Microsoft products is seamless, making for a powerful, high-performance solution. Document updates done in SharePoint are automatically reflected so that your trial data is accurate, current and in sync. And since most CTMS interaction is through familiar Microsoft applications, users work in a familiar interface, so the training is minimal, and the user adoption is high.

End-to-End Clinical Trial Management

Bioclinica CTMS connects the many moving parts of the clinical trial process and lets you monitor progress from a central dashboard. It manages the clinical trial right from the start and maintains role-based access controls across the continuum, from study design through close-out and FDA submission. This end-to-end clinical trial management solution includes the tools to plan, startup, conduct and manage your study, and complete monitoring and regulatory compliance activities. It supports every study aspect: design, procedures, protocol, study arms, visits, forms, treatments, payments and more.

The robust core system offers a range of benefits for improved clinical trial efficiencies and operations:

• Provides the right level of access with views tailored to individual users, whether internal or external
• Provides maximum study visibility for informed decisions at all levels
• Is an ideal governance tool for managing CROs and vendors (consolidates multiple reports/exports a variety of formats and timelines into a central system)
• Supports studies of all types, sizes, phases and complexity in all therapeutic areas
• Is built to demanding scalability specifications of top tier pharma, while providing a right-sized solution for any organization

• Replaces common frustrations and barriers of conventional hard-coded CTMS products with a forward looking Office-Smart solution for a superior user experience
• Accelerates trial lifecycles by establishing efficient processes
• Promotes high user adoption with a low learning curve
• Is backed by superior customer service and 24-hour help desk in over 100 languages
• Can be tailored to your needs, by adding custom fields and features. 
• Automatically re-maps terms if study nomenclature is updated
• Enables information exchange across multiple eClinical systems and third-party applications. Combine it with Bioclinica Electronic Data Capture for a comprehensive eClinical solution.

Automated Workflows

Through automation, Bioclinica creates vast improvements in workflow to improve the way teams work:

• Logistical and operational data are centralized for streamlined management and enhanced control
• Clinical operations and critical business processes across the trial lifecycle are aligned within the regulated environment
• All the moving parts of global trials and various stakeholders are connected by removing communication barriers and facilitating collaboration
• Automation for reviews and approvals ensures nothing slips through the cracks
• Compliance and traceability ensure data and activities are auditable for accuracy and completeness
• Original, modified and actual milestone dates can be tracked across studies, countries and clinical sites
• Site monitors and study managers have one place to see data across all studies
• Many users can access data for their specific needs
• Streamlined dashboards provide the operations team with visibility into all clinical studies
• Extensive standard and custom reports provide quick answers

Value-Added Capabilities

Bioclinica has a unique set of value-added capabilities that complement its robust core system and go above and beyond any other CTMS. This includes:

• Monitoring Visit Report (MVR): Bi-directional data flow between Microsoft Word and Bioclinica enables monitors to enter information with or without an internet connection. The MVR auto-populates report templates and updates the system automatically for significant time and labor cost savings. 2012 Microsoft Life Sciences Innovation Award winner, MVR
• ClinicalTrials.gov: Bioclinica CTMS generates electronic submissions in the required format for clinicaltrials.gov.
• Payment Module: The module drastically shortens payment cycle times, automates invoicing and includes contract/budget management exchange rate accounting tools. It supports Sunshine Act Reporting compliance for cash transactions and enables study data to be easily combined with other payment information in an aggregate spend system.
• Contact Management: Manage contacts and institutions to reflect multiple, real-world relationships of study personnel. Information is accessible in Outlook.
• eTMF Integration: Bioclinica integrates with eTMF vendors and continually updates document statuses so they can be used to trigger CTMS workflow and alert logic.
• Extensive Standard Reports: Get instant operational visibility into Key Performance Indicators with real-time data and easy exports to both Excel and Adobe.
• Robust Reporting and Tracking with Customer-Defined Milestones: Track original, modified and actual milestone dates across studies, regions and clinical sites. Visualize progress using SharePoint calendars and charts through MS Project integration.
• Inventory Control Module: Tracks shipment and dispensing of general study supplies, equipment and test articles so that the location and product balance at each site is always known (i.e. lot numbers, expiration dates and reconciliation information).
• Single Sign On (SSO): Claims-based security and authentication across Bioclinica products simplifies the user experience.