ClinTrialStat e-Clinical Solutions provides high performance, single platform, web-based process support for clinical trial management, site monitoring, and clinical data operations.

Agile coordination, communication, and control are critical factors to bringing in your clinical projects on time, on target, and on budget. Our innovative and fully integrated e-clinical solutions provide the operational infrastructure you need to confidently combine and utilize available resources to achieve your objectives in a secure, easy-to-use, and fully audit trail controlled Internet workgroup environment.

Whether your study requirements are for clinical development or clinical pharmacology, paper-based or EDC, or some hybrid of the two, our system solutions are sharply focused on maximizing your command over your clinical business operations and minimizing the required time to lock the database. This is achieved via our uniquely coordinated user workflows in a single collaborative work space. Your studies are efficiently administered from the first patient in to database lock in a unified and easy to use e-clinical environment.

Trial Management

ClinTrialStat e-CDM features an integrated suite of study and site management support facilities for the tracking of patient enrollment, monitoring activities, investigator payment disbursements, and clinical supplies. There program also features a sophisticated and customizable performance metrics engine for maintaining a steady grip on resource efficiency.

Our “zero client” web implementation means your project Team members can access the system from any workstation connected to the Internet without loading any kind of special software. Furthermore, the role-based security features allow each user to access only those facilities and patient records for which they are granted access.

SAE, site qualification, initiation, monitoring, and closeout visit reports are prepared, posted, and approved online as are phone contacts and the tracking of activity on specific issues. With ClinTrialStat e-CDM, near real-time patient enrollment and safety profiles are at your fingertips. If you are running paper based clinical trials, point-and-shoot access to the CDM system allows you to directly monitor the progress of CRF reviews, data entries, and site query processing.

Electronic Data Capture

ClinTrialStat EDC provides a unique blend of system navigation, Team communication, and data entry support features all of which is focused on enhancing investigative site acceptability, productivity, and overall user satisfaction.

We are particularly intent on providing individual site personnel with the best possible EDC experience through reliable system performance, intuitive interface designs, and friendly attentive help desk support. Transforming investigative site perceptions of EDC from an annoying chore to a fully embraceable and opportunity enabling technology is one of our principle commitments. We believe this process is critical for Sponsors to begin to realize and utilize the full potential and force of Internet technology in the streamlining of their clinical operations.

Key Features:

An ultra sleek client, fully Internet-based, which means that no additional software is required at the site
Intuitive data module design, visit navigation, and process completion tracking
Real-time, point of entry edit checking, auto query generation, and status tracking
Automated enrollment tracking and integrated patient profiles generation
Exceptional data clarifications and the ability to monitor the query processing interface
Secure broadcast and private instant messaging facility with a audit trail
Fully integrated with electronic diary, QOL, ECG, and laboratory update feeds
Protocol specific user guides, on and off-line support system and eCRF training

 

Site Monitoring

ClinTrialStat EDC also provides full functional support in monitoring clinical site activities. Efficient use of our EDC technology presents Sponsors with a genuine opportunity to significantly reduce unit operational costs and travel expenses by minimizing the number of necessary monitoring visits required for a particular study or set of studies.

Often an initial monitoring visit is spent scrutinizing patient records for hidden events that may have been overlooked in summary reporting. With EDC, the CRA can conduct their safety review remotely without the need for physical access to the site records. Remote access also allows the monitor and project manager to more efficiently schedule site visits and the duration of such visits by more effectively matching Source Document Verification (SDV) workloads with existing database content.

ClinTrialStat EDC supports patient record SDV processing at the data field level. Monitors are able to efficiently execute database verification processing via automated and flexible system navigation and status tracking aids. Monitors also have a powerful set of interactive database queries, reporting, and listing tools available for cross-patient evaluations. This ability combined with the visit reporting and issue tracking facilities described above, means that ClinTrialStat EDC-enabled CRAs are well-equipped to leverage system functionalities to optimize both productivity and process costs.

Data Management Coordination

The ClinTrialStat single-platform system architecture offers tremendous advantages that other competing technologies available in the marketplace today simply cannot. This fact is particularly evident in its proven impact on accelerating the clinical data management process.

Most commercial EDC systems simply collect patient data from sites and transfer the content to stand alone CDMS systems for cleaning and database lock. Different versions of this antiquated and backwards hands-off method have precipitated so many operational bottlenecks, horror stories, and timeline disruptions to deter even the most interested Sponsors from considering EDC as a viable clinical business solution.

Our single-platform architecture removes this common process failure. Data collected at the sites remains within the ClinTrialStat system throughout the data cleaning and database locking cycle. Data managers perform their eCRF review, query generation/resolution, and reporting completely within the EDC User environment, creating a single, unified image of the study database. This completely removes any threat of unsynchronized data transfers and minimizes risks of DM process disconnects. The advantages of the EDC User environment combined with our versatile DM review and collaborative workflows, enhances the potential for speedy database locking and trial closeout.

Application Service Provider (ASP) Model

Choosing our ASP deployment option means you can full access to the benefits and functionalities of the ClinTrialStat system on a study-by-study basis, without the upfront investment required in process development and support infrastructure.

In other words, you lease the system and a dedicated ClinTrialStat project team, for the duration of your trial. Once a project has been assigned, a project manager is designated to oversee the entire process from trial setup, qualification testing, and User training straight through to database lock and trial closeout. We then deploy the rigorously tested protocol application on an ClinTrialStat web server. We are also responsible for handling of daily system administration, web-hosting, and User help desk support.

In addition, we also provide a full range of clinical support services. Data management coordination is a core component, and we perform this function as either an exclusively assigned responsibility or as an adjunct to your data management staff. We will further provide clinical project management and regional site monitoring services in association with our Preferred Clinical Services Partners.