1-biometry

Biometry

Highly-skilled team dedicated to your projects assuring you on fast and quality work. Our most experienced Data Managers, Programmers and Biostatisticians are coming from the Big Pharmaceutical Companies.

AIXIAL Biometry department is located in Brno, in the Czech Republic.
 

DATA MANAGEMENT

  • Consultancy in selecting the best data management system for particular clinical trial
  • Design of Case report forms (CRFs) to be used in printed version or as eCRF
  • Providing full services for complex data management process before, during and after clinical trial in line with ICH GCP
  • Experiences with variety of eCRF systems, flexibility to use the most suitable for particular study in compliance with FDA 21 CFR Part 11
  • Integrated and 21 CFR Part 11 compliant eCRF: randomization module, drug dispensing module, lab values module, ePRO module
  • Elaboration of complete documentation related to data management services
  • Medical Coding
  • Conversion of data to SDTM CDISC format
  • Training site personnel on data management system including help desk during clinical trial

 

BIOSTATISTICS

  • Using SAS software
  • Interpretation of Clinical Trials results
  • Phase I, Phase II, Phase III trials
  • Late-Phase studies, registries
  • Epidemiological studies
  • PK, PD studies
  • Consultancy in statistical design and methodology of clinical trials including sample size estimates
  • Preparation of randomization and its full implementation (Generation of dummy/master randomization list and preparation of sealed envelopes)
  • Adaptive designs
  • Writing of statistical section of clinical trial protocols
  • Independent conduct of interim analysis and preparation of materials for Data Monitoring Committee (DMC) and Data Safety Monitoring Boards (DSMB)
  • Generation of materials to support (medical) review of data during the study (complex data listings and patients profiles)
  • Elaboration of Statistical Analysis Plans (SAP)
  • IVRS / IWRS
  • Complex statistical analysis of data from clinical trials in line with relevant ICH GCP guidelines using SAS
  • Generation of Tables, Figures and Listings (TFL)
  • Elaboration of Statistical report to be used for completion of Final clinical study report
  • Close collaboration with medical writers and data managers in preparation of study reports and scientific manuscripts
  • Conversion of data into CDISC AdaM format

Clinical operations & development

AIXIAL offers pharmaceutical, biotech and medtech companies full coverage of Phase I-III and late phase clinical studies for drugs and [...]

Vigilance & medical information

AIXIAL offers pharmaceutical, biotechnology, medical device, nutritional and cosmetics companies full coverage for post-marketing vigilance and product safety in Phase [...]

Regulatory affairs

Preparation and submission of tender files to the relevant authorities Management of registration files: • Drafting of marketing authorization applications [...]

Quality assurance

Audits (investigator sites, CROs, PV System audit) Quality control of documents submitted to relevant authorities Drafting and revision of procedures [...]