Clinical Data Management

Our Data Management Team is offering the full spectrum of services required to effectively perform all data management operations of a clinical study, from study inception, set-up and planning, to study conduct and continuous data monitoring, to final data cleaning, audit, database lock, export and TMF archiving, following a comprehensive quality system of SOPs, QC checklists, and document specifications for each process. . 

The main principles underlying our clinical data management approach are:

Ensuring data integrity and data quality throughout the trial’s lifecycle, from initial setup to final database lock and export, by incorporating data integrity and quality considerations in the design of all our existing and tested data management procedures (SOPs) for all stages. For each distinct procedure, these are implemented through a set of specified controls, such as detailed specifications and checklists, as well as through tools, including software tools to monitor the trials progress in real time and data quality dashboards, reports, and indicators. These tools allow the data management team to have a real-time view of data quality at different levels of detail, from high-level indicators to the status of an individual CRF or variable.

·Ensuring regulatory compliance, by strict adherence to GCP requirements (ICH E6) and all other applicable ICH guidelines (E3, E8, E9, Q9) as well as to requirements for computerized systems and electronic data, as specified by relevant EMA and FDA regulations. Our QA system, operations and software systems are regularly audited internally and by independent GCP auditors to ensure the compliance of our data management services as applied to the trials we undertake.

Applying industry best practices and international standards, such as the SCDM (Society of Clinical Data Management) GCDMP - Good Clinical Data Management Practices, ISPE (International Society of Pharmaceutical Engineers) GAMP5 - Risk Based Approach to Compliant GxP Computerised Systems, as well as ISO standards for quality, information security, risk management and project management.

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Applying continuously risk assessment and risk management, with the aim to identify early emerging risks and effectively mitigate them. To this end we use risk management software tools (risk registers) as well as an extensive set of risk indicators, produced from the clinical database and continuously updated and monitored. Risks are communicated to the sponsor and risk mitigation actions are decided in close cooperation with the sponsor.

Providing information to the sponsor in a continuous and transparent way, not only through well-established communication procedures and regular reporting, but also via access to monitoring tools and dashboards.

Using digital technology to integrate all data, processes, and operations. Using our own secure and validatedcloud EDC and Clinical Trial Monitoring System, developed, and supported by our own in-house software development team, allows us to quickly adapt the system to the specific needs of each distinct clinical trial. Moreover, we operate a completely digital, paperless process using cloud-based systems for documentation management, task management and process records. This allows the efficient communication and coordination with the other teams of the trial and ensures the integrity of all records required for regulatory purposes. 

Our team includes trained clinical data managers with post graduate academic background in biostatistics and health sciences and many years of experience in multinational, multi-site studies, as well as qualified MDs for medical monitoring.