ERGOMED

Clinical Development Services

Clinical Data Management & Biostatistics

Clinical Data Management

Ergomed offers a full data management service for paper and electronic CRFs for clinical trials (Phase I to IV), non-interventional studies and retrospective data collection. We are co-operating with selected EDC vendors, alternatively we can support your selected eCRF system. Clinical Data Management is performed by experienced teams and the clinical data managers, data associates and database developers have many years of experience in the pharmaceutical and life sciences industries.

The systems and software platforms used are fully validated to comply with international regulations, including 21 CFR Part 11, and are supported by a full complement of IT SOPs. Our services cover the complete range of your trial from Data Management Plan (DMP) and Data Validation Plan (DVP) development through Case Report Form (CRF) development (for both paper and electronic CRFs).

Database design and validation, edit check programming and validation, double data entry (paper CRFs only), query management, medical coding (MedDRA and WHO DD), SAE Reconciliation, external data import (e.g. central laboratory) to interim or final database lock and data export to biostatistics.

Biostatistics

Ergomed offers full biostatistics services for clinical trials (Phase I to IV) and non-interventional studies and retrospective data analysis. Biostatistics is performed by our statisticians who have many years of experience in the pharmaceutical industry and have worked on clinical trials in most therapeutic areas. We use SAS as statistical software, the installations are fully validated as required by international regulations including 21 CRF Part 11.

Our services cover the complete range of your trial from statistical input to the protocol design through randomization, Statistical Analysis Plan (SAP) development, independent statistical support for Data Safety Monitoring Boards (DSMB), Blind Data Review Meetings (BDRM), blinded or unblinded interim analyses, final data analysis, creation of tables, listings and figures for the Clinical Study Report (CSR) to statistical input to the CSR.

We also offer the creation of CDISC SDTM datasets ready for submission to the FDA.

Translate »