P10. Alcedis GmbH (Alcedis), Gie├čen, Germany
Principal Investigator: Elke Heidrich-Lorsbach

As an independent clinical research organisation Alcedis supports scientific study groups and the pharmaceutical industry in the implementation of clinical trials.
Our modular service concept fits to the individual requirements of clinical trials as well as to the needs of our clients. Since more than 15 years, Alcedis develops and employs web based software for an efficient data capturing, data and study management.

Alcedis commits itself to the following principles:

  • to carry out clinical trials result-oriented and on a high quality level
  • to constantly improve methods and concepts
  • to support actively the motivation and identification of stakeholders involved in a clinical trial

Alcedis main task in OCTIPS is to provide an efficient IT infrastructure to the project. This will encompass the development and operation of web based software module(s) for: 

  • an efficient electronic data capture of clinical data as well as for sample recording and tracking
  • a comprehensive scientific exchange  (communication and conference tools) 

All software modules are qualified for use in the regulated environment and are validated according to the “Good Automated Manufacturing Practice” (GAMP) Guideline. 

Alcedis looks back on a close collaboration with most of the OCTIPS participants. Joint projects were the set up of a web-based data base in the FP6-funded OVCAD (Ovarian Cancer - Diagnosis of a silent killer) project that predicts the survival of ovarian cancer as well as the TOC (Tumour bank ovarian cancer) database.

In order to further develop standards, methods and tools, Alcedis participates in following working groups:

  • GAMP Special Interest Group (SIG): validation of EDC systems in clinical trials
  • Set-up of a core data set for oncological care (Germany)
    (to be used for epidemiological cancer registries, quality assurance, benchmarking)
  • Asklepios Future Hospital (AFH)
    (development and test of innovative IT technologies before roll-out in the Asklepios group)


    Maria Naim              Elke Heidrich-Lorsbach