Manage your study intelligently and efficiently

SOCAR's web-based eClinical solution, eSOCDATTM, integrates Electronic Data Capture (EDC), Clinical Trial Management (CTMS) and Clinical Data Management (CDMS) in the one system. eSOCDAT encompasses the full spectrum of functionalities that is necessary for the setup, conduct and reporting of any type of clinical research study. This all-in-one software is capable of capturing, accessing and streamlining clinical and operational metadata between all trial sites and project stakeholders. This simplifies and optimises the workflow for the multidisciplinary teams involved in clinical research without compromising on quality.
eSOCDATTM offers an exhaustive suite of modules that cover all activities relating to Patient, Site and Overall Study Management and which include Event Adjudication, DSMB management, Deviation tracking, eTMF, Payment tracking, Site selection, Site management, Submission tracking, Site contact tracking, Risk Based monitoring and a multitude of metric and status reports.
All eSOCDAT functionalities are integrated into a unique web-based system with 24/7 access for authorised users.

all-in-one system

The eSOCDATTM EDC, CTMS and CDMS Systems are interconnected in one system with the most exhaustive suite of modules that you would ever need to conduct your research project.
Designed by clinical trialists, eSOCDATTM has all the necessary components to enhance and accelerate the timelines from study design and build through to the study closeout phase.

to any clinical research project

eSOCDATTM can be easily configured and customised to the requirements of each clinical research project, irrespective of the project size and complexity.


Designed by clinical trialists, eSOCDATTM has all the necessary components to enhance and accelerate the timelines from study design and build through to the study closeout phase.


The study configuration tools are highly intuitive and well laid out enabling complete flexibility in study design/configuration. Changes are deployed without causing downtime to the system. End-users can easily navigate within the System between the large suite of eSOCDAT modules.

discover eSOCDATTM

integrated suite of modules

Site Selection
The 'Site Selection' module enables users to capture and track all activities relating to site selection. Once the list of potential sites is imported into eSOCDAT, email invites are issued directly from the System and sent automatically to the potential sites. Site personnel can complete the Site Qualification form in this module directly - the latter is easily configured to the requirements of your trial. Thanks to this module, users have, in the one System, complete management and oversight of each step in the site selection process.
Regulatory Green Light
The 'Regulatory Green Light' module enables tracking of the approvals (e.g. Regulatory, Ethics/IRB and local administrative) which must be obtained before site activities can commence for your trial. When using this module, users have the possibility to prevent sites from receiving study materials and/or from starting to consent patients until all required approvals have been obtained.
Lab. Normal Ranges
The 'Lab Normal Ranges' module enables the capture of the local laboratory normal ranges for each site, for the assays to be assessed for each trial. If a Central Laboratory is used, users can also capture the Central Labs normal ranges in this module. During data management activities, the results for each assay may be cross-checked with the normal ranges to identify the assays that are outside the normal range and/or to check the plausibility of the unit reported in the eCRF for the assay concerned.
Delegation Log
The eSOCDAT Delegation Log enables users to capture and track the required information concerning the tasks delegated to each member of the site team assigned a role in your trial. Any change made to an individual’s role/responsibilities after the initial (electronic) signature by the site Principal Investigator (PI) are tracked via the module’s audit trail and all such changes will require re-signature by the PI. Using this module will ensure compliance with ICH E6, section 4.1.5 and removes the need to use paper delegation logs.
The eISF module enables authorised users to manage (i.e. upload, download, validate, track documents) which are part of the study Trial Master File (TMF) at the site level. The eSOCDAT eISF module follows the principles of the Drug Information Association’s (DIA) TMF Reference Model. In addition, within this module, meta-data is tailored for each document type.
eCRF, data queries, randomisation
  • The 'eCRF' module is a user-friendly interface that enables the creation of eCRFs which are tailored to meet the requirements of each specific study. Access to the EDC module is user and role restricted with each user having his/her own, unique password, username and permissions. This user-access controlled module enables site users to easily and seamlessly enter data into the eCRFs and to easily navigate within visits and to all forms/pages that should be completed. Built in real-time edit checks help to ensure the completeness of the data entered. Access to specific eCRF pages and specific questions on any eCRF page can be limited to specific users if required by your study. The EDC system is fully compliant with 21 CFR part 11 requirements and includes a complete audit trail.
  • Concerning data queries, sites can directly access and resolve data queries posted by the data management group.
  • The randomisation system is built into eSOCDAT – no interface to another external system is required so sites randomise patients directly in eSOCDAT.
Screening Log
The 'Screening Log' module enables sites to track all patients pre-screened for participation in your study. It enables real-time oversight of site pre-screening activities to ensure that sites are (a) focussing on and pre-screening the correct patient population per the study protocol and (b) to detect real time problems which become apparent with recruitment on a site, country, or global basis.
The 'ePRO' module enables patients to complete self-administered questionnaires on-line. Email reminders can be issued to patients to remind them when questionnaires should be completed and real-time built in edit checks help to ensure that patients complete all questions.

IWRS randomisation
The 'IWRS randomisation' module is built into eSOCDAT – no interface to another external system is required so sites randomise patients directly in eSOCDAT. The module supports open or double-blind, multi-strata, multi-group randomisation based on a block list or a widely configurable range of algorithms such as minimisation. The randomisation list can include blocks of any size linked to an unlimited number of defined patient group criteria and stratification parameters.
Trial Supply Management (Drug management)
The 'Trial Supply Management' module enables the capture of all information required to track study treatment supplies which includes information concerning the country / regional depots if used to ship study treatment supplies to the sites and the inventory at each depot. For multinational studies, it is possible to track batch release dates by country – i.e. date when the Qualified Person (QP) release was obtained for each of the participating countries for the batch number concerned. In addition, site (re)supplies can be issued directly from this module either automatically and/or manually – there is a complete tracking from date the request was issued to when received at site. At the site level, the System tracks expiry dates and takes this into consideration when allocating study treatment to any one patient. This module is IRT certified by some of the leading drug shipping companies.
Site Monitoring
The 'Site Monitoring' module enables authorised users to register and manage all site contacts (e.g. pre-initiation, initiation, monitoring, close-out visits/email/telephone reports or remote monitoring activities) and to complete the site contact reports directly in eSOCDAT. The content of each visit report can be easily configured to the specific requirements of your study. Site contacts/visit reports can thus be managed and tracked very efficiently in the one system and the tracking of action points can be easily followed until resolution. Sponsors have 24/7 oversight of what’s going on at any time with any site.
Risk-based Monitoring
The 'Risk-Based Monitoring' module is an innovative, powerful and scalable tool to enable users to implement the Risk-Based Monitoring (RBM) strategy/rules per the risk-based monitoring plan. This module is extremely flexible as users can implement the RBM rules either by patient, for a subset of patients with a specific demographic (e.g. gender, age) or a specific condition (e.g. diabetes, hypertension) or for specific visit/record types. Users can also define a percentage of patients/visits that require monitoring to be performed. The patients/visits/records requiring monitoring will be displayed in the eSOCDAT Source Data Verification module ('SDV') module.
Study Oversight
The 'Study Oversight' module contains powerful tools enabling all stake holders to have a clear vision and complete, real-time study oversight. Robust metrics and status reports can be made available to authorised users and can be monitored 24/7. Study and site level Dashboards are readily available and easily accessible by users to guide the work flow. Users can track the study milestones including leading or lagging time via the ‘Milestone’ part of this module. Users can create and access metric and status reports which are displayed on the screen to track, amongst others, recruitment progress, key performance indicators and key risk indicators.

The 'eTMF' module enables authorised users to manage (i.e. upload, download, validate, track) documents which are part of the study Trial Master File (TMF). This module is user and role restricted and thus enables authorised users to either upload and/or download documents. The meta data is specific to each document type and place holders can be set-up for documents that require renewal or which are expected to be received. The eSOCDAT eTMF module follows the principles of the Drug Information Association’s (DIA) TMF Reference Model.
The 'Adjudication' module supports all activities relating to event adjudication. It enables the generation of eCRFs to be completed directly in the System by the site personnel for events assigned for adjudication – each eCRF will be specific to the event type requiring adjudication. The receipt of all source documents required to make up the adjudication packages can be fully tracked thus allowing a real-time status. Assignment of events to adjudicators can be done via a programmed and validated algorithm or performed manually. Adjudicators are notified by email that events are ready for adjudication – the frequency of these mails can be determined for each trial and can be adapted over the life-cycle of the trial. Adjudicators complete the tailored adjudication forms directly in this module. Adjudicators only have access to events assigned to him/her and are not aware of the other adjudicator with whom he/she has been paired to adjudicate the event, thus enabling complete independence between the two persons adjudicating the events.
Training Tracking
The 'Training Tracking' module enables users to record and track all training performed for site and non-site personnel involved in your study. The training materials/documents used for the training can be easily accessed in the eTMF via a document hyperlink present in the Training Tracking module. Placeholders can be created for training that requires renewal over the life cycle of your study and re-training on a same document version can also be tracked. Access to this module is user and role restricted and each user has access only to his/her training details. Documents which are uploaded in the eTMF and require training to be performed become automatically available for training by specifying the relevant user roles. Each user will (electronically) sign his/her training performed.
Deviation Management
The 'Deviation Management' module enables users to record and track all deviations which occur over the life-cycle of your study. Patient-related deviations can be created automatically and non-patient related deviations, manually. For each deviation, users can assess the impact of the deviation on patient safety, data quality, and integrity as well as track the action(s) taken for each deviation – e.g. perform a CAPA, or re-train the site personnel etc. From the data compiled in this module, users can easily create a report to send to the Ethics Committee /Institutional Review Board per the local requirements. Sponsors have real-time oversight (24/7) to information concerning the occurrence and management of deviations.
Submission Tracking
The 'Submission Tracking' module is a powerful tool that enables users to capture and track all information relating to the Regulatory, Ethics/IRB and local administrative submissions. Users have real-time access to the status of each submission type. In addition, via this module, users can compile all documents required for a submission into one file, on the assumption that all documents required for a submission are uploaded in the eTMF.
Meeting/Payment Tracking
The 'Meeting Tracking' module enables users to track all meetings (e.g. Steering, Adjudication Committee, Sponsor, Internal, Investigator, CRA meetings ) that take place over the life-cycle of a study capturing the meeting date, location and attendees.

The ‘Payment Tracking’ module enables tracking of payments made to sites – e.g. patient related per the milestone payments in the site contract – the milestone payment timings can be tailored per the contract requirements, reimbursements for travel / hotel accommodation costs relating to meetings and/or payments made to Committee members.
Data Management
The 'Data Management' module enables enables the DM team to efficiently execute all data management/cleaning activities over the life cycle of a study. Tailored data checks are defined and programmed/validated and implemented in the System for each study. The DM team can then run the data checks per the frequency described in the Data Management Plan and post data queries as appropriate for sites to resolve. The DM workflow and progress is guided with powerful and intuitive metric reports generated directly within the System. To facilitate the efficiency of the DM team, when the data checks are run, data queries are automatically inserted into the data query field. Visits can be 'soft-locked' as the data cleaning is performed, thus accelerating the time to database lock at the end of the trial.
Coding of medical terms and concomitant medications
The 'Coding' module enables the coding of medical free text – e.g. adverse events, free text medical history and concomitant treatments using the Regulatory approved (e.g MedDRA, WHO-DD) respective medical coding dictionaries. The Coding dictionaries are fully integrated in eSOCDAT thus eliminating the need to import/export data requiring coding to another platform. Using powerful search tools, automatic and manual coding of site reported verbatim terms can be done instantaneously after the data has been entered by the sites. The coders can post queries as appropriate for sites directly in the System. Another special feature of this module is the ability for an independent coder to perform a QC check to validate the coding done. Using this module will thus guarantee a timely and accurate coding of verbatim terms and will hence ensure that reliably coded data is always available for safety reporting.
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