Clinical Data Management


A team of highly experienced data managers will support all CDM-aspects of your project. Individual trial databases are developed according to your project’s requirements, being subsequently checked and validated prior to transfer to the production level.

All analysts in the medical data team are physicians with outstanding up-to-date competence and experience in data evaluation and data coding (using standard dictionaries such as MedDRA, WHO-DD or client specific dictionaries).

The complex variety of clinical trials is calling for customised and properly tailored data management solutions. Whether paper-based, EDC supported or as a hybrid solution, acromion GmbH can offer you an assortment of options. We will in depth analyse the specific needs of your particular project recommemding the most suitable approach.

acromion GmbH is working with ACROSYS (acromion DMS), a data management system based on Sybase/PowerBuilder specifically tailored for the management of clinical trial data. It has been developed in respect to high-level standards in clinical research and is validated according to GAMP 5. This system guarantees best conformity to CFR 21 Part 11 and ICH-GCP requirements in rapid and efficient processing of clinical trial data.

The complex variety of clinical trials is calling for customised and properly tailored data management solutions. Whether paper-based, EDC supported or as a hybrid solution, acromion GmbH can offer you an assortment of options. We will in depth analyse the specific needs of your individual project offering you the most suitable concept.

  • Data import, such as laboratory or central reading data, as well as
  • Data export to your final storage destination.

acromion GmbH data management services include:

  • Development of data management plans
  • Implementation and test of trial databases
  • Development and implementation of validation checks
  • CRF- and query-tracking
  • Independent first and second data entry with a third person comparison
  • Data coding by experienced medical data analysts (MedDRA, WHO-DD, sponsor specific coding dictionaries)
  • Translation of CRF-entries
  • Data validation and plausibility checks by medical data analysts
  • Electronic and manual query generation
  • Medical data review by specialized medical data analysts
  • Generation of trial status reports, data listings and graphs
  • Processing of post marketing surveillance trials and NIS incl. grant payments’ administration
  • High physical data security
  • Data import and export of to common and special standard formats (e.g. SAS, ASCII, CDISC)
  • Reconciliations of several data sources (e.g. SAE reconciliation with companies safety database)

Your Contact

Stefan Herrmann
Senior Data Manager
acromion GmbH

Europaallee 27-29
50226 Frechen

Phone: +49 (0)2234-20 37 37-28
Fax: +49 (0)2234-20 37 37-9


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