SOCAR's e-Clinical solution

Summary of features

e-SOCDAT™ is an innovative, complete, homogeneous and (dynamically) tailorable e-Clinical solution, providing the following features:

e-DESIGN

The e-DESIGN interface enables the design and creation of e-CRFs, the development and implementation of online queries, and the development of instructions and guidance for data collection and e-CRF completion.  [...]

e-DC

The e-DC feature allows site personnel to capture and access data for patients from their site. Sites can also easily upload attachments (e.g. electrocardiograms, laboratory test reports, scan reports...) in the system. The quality and completeness of the data are enhanced during data capture by automated, validated online queries and instructions and guidance available online. The electronic data management functionality facilitates a true multidisciplinary approach to data management.  [...]

e-STA

The e-STA feature allows web-based randomisation, the management and tracking of study treatment/investigational device supplies in addition to a secure and role-restricted access to the study treatment code.  [...]

e-DATAM

The e-DATAM functionality enables access to, and an optimal utilisation and cleaning of, clinical (serious and non-serious adverse events included) and operational metadata between members of the research project's multidisciplinary team. This process includes the coding of medical data and concomitant treatments in addition to the ability to upload reports in the system. These facilities are essential to ensure an effective communication flow between all stakeholders, thus assuring a timely setup and completion of the study with highest possible data quality. In addition, real-time, quality reporting facilitates effective decision making.  [...]

e-STUDYM

The e-STUDYM functionality enables the management and sharing of clinical and operational metadata easily and efficiently between the multidisciplinary teams involved in a research project from a variety of locations (i.e. sites, sponsor and coordinating centre) by the use of online reports / listings, automatic email notifications. This functionality also enables CRAs to easily manage on-site visits or contacts and to easily complete and track their Source Data Verification (SDV).  [...]

e-TMF

The e-TMF functionality enables the electronic management of the Trial Master File (TMF). The TMF documents, once uploaded, are visible on a continuous basis for authorised users.  [...]

e-PRO

The e-PRO functionality enables patients to access directly (via the web) study-specific questionnaires or self-administered documents (e.g. diaries, compliance checking) requiring completion. This is a very simple and intuitive functionality for patients to use as no additional software or hardware is necessary – they can simply access the questionnaires via a user-restricted website.  [...]

e-ENDPTM

The e-ENDPTM feature enables the electronic collection and management of data required for endpoint adjudication in addition to online adjudication by the Clinical Endpoint Committee (CEC).  [...]


 
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