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Aix Scientifics®   Clinical Research Organisation

Clinical Research for Pharmaceuticals and Medical Devices

We can support you during the steps of product development and certification considering the scientific basis, the guidelines, the standards and legal environment.

  • Preclinical research for medical devices .
  • planning on basis of own animal-surgical experiences
  • scientific study design, and statistic and logistic planning
  • drafting of the study plans, applications, CRF and other documents
  • evaluation of study results and report writing
     
  • Planning and design of international clinical studies .
  • for pharmaceuticals (clinical studies phase II-IV)
  • and medical devices (all phases)
  • scientific study design, statistical and logistical planning
  • drafting of the study plans, CRF, patient information, and other documents
  • with competence in internal medicine, cardiosurgery, neurology / psychiatry, immunology, transfusion medicine, microbiology, dermatology, and radiology
     
  • Implementation and Management of Clinical Studies
  • support you to select the clinical centres and to plan the logistics
  • contact investigators, Ethics Committees, government and Notified Bodies
  • quality assurance, auditing according to Good Clinical Practice (GCP)
     
  • Data Management .
  • appropriate planning of the data acquisition and management
  • peculiar multilingual Internet-based remote data system eCRF.uk with SQL data base,
  • online randomisation, online data validation and real-time status data
  • ensuring better data quality and rendering possible timely completion
     
  • Evaluation of Study results
  • statistical evaluation using standard software (. sas®)
  • writing biometrical and clinical study reports, as well as expert reports,
  • based on the study protocol, ICH, and SOPs
     
  • Expert reports and clinical evaluations for medical devices
  • on basis of own medical and pharmacological experiences
  • on basis of own experiences as industrial designer
  • on basis of ca. 20 years experience with the realisation of clinical studies
     
URL: https://www.aix-scientifics.com/en/research.html     ( QR | DM  code ) (vCard) [printed: 21.08.2017 02:52]
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