Data Management

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In apices we know clinical trial data management is as critical as ever.

  planning and resources ensure quality of data, it is our main objective for clinical data management always complying with timelines and budget.

APICES data management services are tailored to fit your clinical study needs – from individual stand-alone service to full functional outsourcing of large groups of studies, from interventional to non-interventional studies – to provide the most flexible and cost-efficient service, including but not limited to:
> Database design, validation, and release.

> Data Management Plan.

> Data Validation Plan.

> Programming of edit checks.

> Interactive Web Response System (IWRS) for randomization/patient enrolment

> Listings and blind codes generation for randomized studies.

> Case Report Form design / Electronic Case Report Form programming and management.

> Coding according to international dictionaries (e.g. MedDRA, WHO Drug).

> Double data entry (for paper based-CRFs or questionnaires).

> Data Review Meetings.

> Database reconciliations.

> Database preparation for regulatory submissions.

Highest quality of data is the aim of our clinical data management professionals with implementation, according to sponsor needs, of the Clinical Data Interchange Standards Consortium (CDISC) recommendations.

APICES offers communication to our database which facilitates data control for our customer and arrange Data Review Meetings with the customer, if requested.

Our Electronic Data Capture and Data Management Systems are fully validated and are FDA 21 CFR Part 11, EMA/INS/GCP/454280/2010 and ICH-GCP compliant. The validation of the system provides objective documented evidence that the system/application operates accurately, reliability, is reproducible and functions are in accordance with predetermined specifications.

APICES ensures maximum security, integrity, availability, and confidentiality of the study data performing periodic and routinely backups and ensuring that only authorized users can access the computer system and its resources. All your clinical data is stored in an ISO 27001 (information security management system standard) certified Data Center. Our Business Continuity and Disaster Recovery Plans ensure fast recovery in case of any disaster without impacting your business.

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