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Clinical Trial Management System

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. Bi-directional information exchange from Bioclinica CTMS to SharePoint and other Microsoft products is seamless, making for a powerful, high-performance solution.

See how Bioclinica CTMS and CTMS Direct transform a disjointed clinical trial into an efficient and cohesive work environment with Microsoft – the most pervasive office productivity tools in the world.

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.

Leverage Microsoft Assets

The Bioclinica CTMS is Microsoft Office-smart. It lets you leverage the Microsoft 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 synch. And since most CTMS interaction is through familiar Microsoft applications, users work in a way they're accustomed to and training is minimal.

Better Workflow, Deep Savings

With Bioclinia, you can vastly improves efficiencies in both data flow and work flow, 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 offline 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 users or 1,000, 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 efficienciesBioclinica 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 international trials and the 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 ensures data and activities are auditable for accuracy and completeness
  • Tracks original, modified, and actual milestone dates across studies, regions, 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, whether design, procedures, protocol, study arms, visits, forms, treatments, payment, and more.

Get an in depth look at Bioclinica CTMS robust features and functions.

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 enterprise solution with power and flexibility to support studies of all types, sizes, phases and complexity in all therapeutic areas
  • 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
  • Backed by superior customer service and 24-hour help desk in over 100 languages
  • Bioclinica works alongside other leading Microsoft partners and systems integrators.
  • 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: Make electronic submissions in the required format.

Payment Module: Drastically shortens payment cycle times and automates invoicing. Includes contract/budget management exchange rate accounting tools. The module 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.

Resources

White Papers

Because a Clinical Trial Management System (CTMS) defines and manages all the activities that span the clinical trial process, it can be resource-intensive to implement. For this and other reasons, a CTMS is often considered out of reach for small to mid-sized companies.

CRO Governance and Collaboration in Clinical Trials Using CTMS
Increased outsourcing and globalization continue to expand the number of specialty outsourcing specialists participating in a single clinical trial. While outsourcing has brought expertise and cost reductions, the practice has changed team composition, adding more layers of complexity in managing data and clinical trials themselves.
Harvard Clinical Research Institute sees Efficiencies And Savings with OnPoint CTMS

Having grown to a premier research organization with 400 clinical trials to its credit, HCRI's clinical trial management needs had surpassed the conventional processes it had been using to manage and monitor information and documents related to its clinical studies.  In this Case Study, readers c

Blogs

Removing Risk from Clinical Trial Management System (CTMS) Implementations

Join us for our upcoming webinar on November 28th during which Justin Hunt, Director of CTMS Implementation Services at Bioclinica, Inc., will present and discuss a case study providing insight into the benefits realized by a contract research organization (CRO) purchasing a CTMS who s

In our experience, many small- to mid-sized companies view the implementation of a Clinical Trial Management System (CTMS) to be too resource-intensive (finances, time and human resources); because of this and other reasons, many of these companies compromise with systems comprised primarily of m

With thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems—all generating massive amounts of data—clinical trials are an enormous undertaking.

ADDITIONAL RESOURCES

OnPoint Direct

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OnPoint CTMS: Office-Smart Global Clinical Trial Management

Download Data Sheet

OnPoint Direct: Challenges for Small to Mid-Sized Companies

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Reduce the Time to Implement Your Clinical Trial Management System WITH ONPOINT DIRECT

Download White Paper

CRO Governance and Collaboration in Clinical Trials

Download White Paper

Harvard Clinical Research Institute

Download Case Study

Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices