X-act Cologne Clinical Research GmbH

Standnummer: 19

X-act Cologne is an independent and privately owned contract research organisation based in Cologne, Germany and was founded in 1994. We are an experienced partner to the life science industry, obtaining reliable study results for the development of safe and innovative therapies. As functional service provider for clinical data management and biostatistics, we have successfully conducted more than 450 clinical studies in a wide range of therapeutic areas.

Clinical Data Management and Biostatistics: the booster to your project success!

Clinical Data Management

  • Strategic consulting to find the best eClinical solution for your project.
  • eCRF implementation according to CDSIC | CDASH supporting submission.
  • Development of all essential DM documents for your successful project conduct.
  • Implementing Good Clinical Data Management Practices throughout your project.
  • The conduct of all DM activities is supported by the excellent procedures of our SOPs.
  • Targeted data review and data cleaning in close collaboration with your CRA team.
  • Benefit from expressive status reports providing transparency and overview to the study team.

Biostatistical Services

  • Statistical consulting, assuring that your scientific questions are answered.
  • Delivering sample size determinations and statistical input to your study protocols.
  • Development of a randomisation plan. Performing randomisation according to your study requirements.
  • Developing Statistical Analysis Plans with a clear focus on the statistical programming of key results and analyses.
  • SDTM and ADaM Mapping supporting the submisson of your study results.
  • iDMC / DSMB Meeting support (blinded or unblinded)
  • Biostatistical reporting as part of your clinical study / investigational report, publication or dossier.

Further information: www.x-act-cologne.com

Contact

Curious about our special services? Please get in touch with:
Olivia F. Hoffmann, Sales & Marketing Manager
X-act Cologne Clinical Research GmbH
Rudi-Conin-Strasse 4
50829 Köln, Germany

Tel. +49 221 337716-0
Fax +49 221 337716-33
E-Mail: business@x-act-cologne.com
Homepage: https://x-act-cologne.com
LinkedIn: www.linkedin.com/company/x-act-cologne-clinical-research-gmbh

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