SOCAR’s data management systems – SOCDAT™ for research studies using paper CRFs or
e-SOCDAT™ for studies using electronic CRFs – combine clinical data and operational information within the same system. This combination enables an optimal utilisation of the clinical and operational metadata between the multidisciplinary research project team and thus provides the most proficient platform for all project management activities. In addition, these capabilities are highly attractive to ensure an effective communication flow between all stakeholders and to assure timely completion of the study with highest data quality possible.

All project team members are continuously up-to-date with the study status and this process enables an early detection of potential problems and hence, their prompt resolution. This dynamic approach to project management optimises workflow and the proactive implementation of solutions to resolve problems. This means that full control over the research project is achieved on an ongoing basis. Additionally, all team members have readily access to study news and relevant study documentation.

SOCAR’s complete project management activities include:

• Document preparation (e.g. protocol, (e)CRF, patient information sheet and informed consent form)
• Setup of study committees and their subsequent management
• Site selection
• Setup of site contracts
• Site management
• Management of investigator payments
• Setup and maintenance of Trial Master File (TMF)
• Study treatment supply management
• Training of site personnel and project team