Global Clinical Trial Management
Clinical trials are an enormous undertaking. They can involve thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems — all generating massive amounts of data. In order to efficiently manage trials, organizations participating in clinical trials often utilize Clinical Trial Management Systems (CTMS) to consolidate all of their operational data.
Bioclinica CTMS is a powerful end-to-end clinical trials management solution that brings control, efficiency and quality data to every study. This web-based CTMS works on the go, letting you view and manage real-time operational performance — wherever and whenever.
See how Bioclinica CTMS transforms a disjointed clinical trial into an efficient and cohesive work environment with Microsoft – the most widely used office productivity tools in the world. Bi-directional information exchange from Bioclinica CTMS to SharePoint and other Microsoft products is seamless, making for a powerful, high-performance solution.
REDUCE THE TIME TO IMPLEMENT YOUR CLINICAL TRIAL MANAGEMENT SYSTEM WITH BIOCLINICA CTMS
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Leverage 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.
Rapid Start Up
Our streamlined configuration process and standardized reporting package let companies get started with CTMS in as little as two weeks rather than the weeks or months of a traditional enterprise CTMS implementation.
Bioclinica CTMS provides a variable cost subscription model that eliminates the capital investment required in the purchase of a perpetual license and allows our customers to pay only for what they use. With this low-risk implementation, a CTMS is no longer out of reach for smaller organizations or study-specific uses.
POWERFUL CLINICAL TRIAL MANAGEMENT: A RAPID STARTUP CTMS
Better Workflow, Deep Savings
With Bioclinica, you can vastly improve efficiencies in both data flow and workflow, yielding cost-savings in time, labor and operational expenses. Moreover, integrating Office processes with clinical operations can reduce back-office paperwork and significantly lower administrative overhead. And, leveraging existing Microsoft investments means total cost of ownership is low.
Easy to learn and use, Bioclinica CTMS is quickly mastered, which speeds user adoption. It is mobility-enabled in support of the one-of-its-kind Monitoring Visit Report (MVR) module, allowing operational performance to be viewed and managed across programs and studies in real-time via secure role-based web access.
Whether 10 or 1,000 users, Bioclinica CTMS quickly scales, bringing workflow efficiencies and standardized tracking across all studies of every type, in both online and offline modes. Beneﬁts of the full-featured and conﬁgurable Bioclinica become especially apparent in high volume global programs, yet it is an affordable CTMS solution for organizations of any size. Learn about workflow efficiencies Bioclinica CTMS provides.
Through automation, Bioclinica creates vast improvements in workflow. Here's how:
- Centralizes logistical and operational data for streamlined management and enhanced control
- Aligns clinical operations and critical business processes within the regulated environment, dramatically increasing efﬁciencies across the trial lifecycle
- Connects all of the moving parts of global trials and various stakeholders by removing communication barriers and facilitating collaboration
- A high degree of automation surrounding reviews and approvals ensures nothing slips through the cracks
- Compliance and traceability ensure data and activities are auditable for accuracy and completeness
- Tracks original, modiﬁed and actual milestone dates across studies, countries and clinical sites
- Gives site monitors and study managers one place to see data across all studies
- Enables many users to 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
- Optimized workﬂows improve the way teams work
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.
Get an in-depth look at the robust Bioclinica CTMS features and functions.
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
- Is an ideal governance tool for managing CROs and vendors (consolidates multiple reports/exports a variety of formats and timelines into a central system)
- Provides an affordable solution with the power and ﬂexibility to support 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 life cycles by establishing efﬁcient processes that reduce costs and deliver rapid return on investment
- Provides maximum study visibility for informed decisions at all levels
- Promotes high user adoption with a low learning curve
- Is backed by superior customer service and 24-hour help desk in over 100 languages
- Bioclinica works with other leading Microsoft partners and systems integrators.
- Is flexible and supports studies of all types, sizes and complexity. Tailor it around your own needs and add custom fields and features. Update study nomenclature and Bioclinica automatically re-maps the terms.
- Enables information exchange across multiple eClinical systems and third-party applications. Bioclinica integrates within your wider technology environment and adapts with your organization over time. Combine it with Bioclinica Electronic Data Capture for a comprehensive eClinical solution.
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.
Native SharePoint Integration: SharePoint enables the ultimate, cost effective eClinical solution by allowing users to do CTMS work via their Microsoft Ofﬁce desktop applications. This architecture provides large-scale user access with low enterprise implementation costs.
Today, over 300 clinical trial sponsors—including all of the top 20 pharmaceutical manufacturers—depend on Bioclinica.
Schedule a demonstration and learn how Bioclinica CTMS can improve the safety, efficiency and data quality of your clinical trials.