Complete Clinica

Clinical Trial and Research Management

About Complete Clinica
                                                                                   
CompleteClinica is a web-based platform for Clinical Trial Management System (CTMS) used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA). These data form the basis for the Agency's decisions regarding the safety and efficacy of new human and animal drugs, biologics, medical devices, and certain food and color additives. It facilitates protocol configuration, design of Case Report Forms (CRFs), Electronic Data Capture (EDC), retrieval, and clinical data management. Complete Clinica follows the FDA Regulation defined in the Code of Federal Regulations (CFR), ICH GCP Guidelines and HIPAA Guidelines.

Key Benefits

1. Centralized Trial Management Database.
2. Organization of clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs. Support for sharing resources across studies in a secure and transparent manner.
3. Easy and Dynamic generation of web-based CRFs for electronic data capture via user-defined clinical parameters. Supports versioning of CRF for re-use across studies
4. Management of longitudinal data for complex and recurring patient visits.
5. Data import/export tools for migration of clinical datasets in excel spreadsheets, local databases and legacy data formats.
6. Extensive interfaces for data query and retrieval, across subjects, time, and clinical parameters, with dataset export in common statistical analysis formats
7. Compliance with HIPAA privacy and security guidelines including use of study-specific user roles and privileges, SSL encryption, de-identification of Protected Health Information (PHI), and auditing to monitor access and changes by users.
8. A Robust and Scalable technology infrastructure developed using the Java J2EE framework interoperable with relational databases including Postgreas (open source) and Oracle 10G, to support the needs of the clinical research enterprise.
9. Support for system oversight, auditing, configuration, and reporting
10. Double data-entry support, and reconciliation with built-in discrepancy/query management
11. Data output to common statistical analysis formats.
12. Data model based on CDISC standards for interoperability
13. Database and operating system independent

Benefits using C2

Improving Clinical Trial Efficiency
Clinical Trials are complex in nature and takes longer trial duration. This increases the cost of conducting such manual paper intensive clinical trials and manual process becomes uncoordinated. A better approach needed that streamlines trial management reduces trial length, costs and coordination and managing relationships. CompleteClinica Organizes clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs. Support for sharing resources across studies in a secure and transparent manner. This approach focuses on strengthening relationships with trial participants, especially investigators, research team and subjects. This helps in more productive and close result of a trial.

Centralized Trial Management
Clinical trials are increasingly global in nature, conducted around multiple geographies location concurrently. Making trial information accessible to the right people at the right time with the right level of detail becomes ever more critical. CompleteClinica enables clinical organizations to maintain a centralized trial management database while providing users with the most relevant and appropriate information based on their specific roles and responsibilities. Thus, real-time trial information is available not only to clinical research associates managing individual sites, but also to regional managers responsible for geographic areas and to global trial managers managing global trials. Armed with the most current and relevant data, clinical users are able to spot problems earlier and take corrective actions sooner, reducing overall trial costs.
 
Improve Investigator Relationships and Site Performance
Subject Management provides clinical trials in checking up eligibility of subjects to get enroll with right health profile for a trial. Subject enrollment is often time consuming, overwhelming task that may lead to failure in enrolling enough patients in time during the clinical trials. Subjects data can be collected at different sites and the quality of data on each trial from site to site can vary. These information helps investigators in tracking records of subject based on demographics and further enrollment of subjects in trials. CompleteClinica provides extensive User Management and Subject Management that provides a centralized system where organizations can collect and track their investigators based on the work profile, experience, specialties and the current trial status. By analyzing comprehensive investigator data, clinical organizations are able to identify the investigators most suitable for a trial. CompleteClinica provides an investigator administrative right that helps in choosing and managing research team and maintaining relationships, access to subjects data helps in corrective enrollment in trials. This overall improves clinical trial workflow quality and costs.
 

Improve Clinical Trial Productivity
CompleteClinica modularize clinical trial in such a way that helps clinical research associates with an efficient way to track regulatory and other study documents during various stages of the trial, spanning from site initiation to site closeout and at various levels, from site to country to protocol. Alerts are available as part of the System which allows relevant users to be notified for specific interventions such as document review or renewal. User Management, Subject Management, Organizational Contact Management provides clinical research associates with a powerful tool to actively maintain contacts of organizations, users, subjects with sites, and to manage issues through to resolution. clinical research associates can schedule site visits based on investigators’ availability, site enrollment, or completed work. Schedule and Task Management helps investigator in scheduling and assigning task to user based on the availability of subjects and sites. Report Management provides a platform for an easy and efficient way to generate Managerial level and Administrative level reports.
Thus, by integration of this modules significantly increases Clinical trials productivity.

CompleteClinica consist of six interrelated modules.

1. Study Management
2. Event Management
3. Subject Management
4. Report Management
5. User Management
6. Configuration Management