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Clinical Data Management & Biometrics

The Data Management & Biometrics Department provides all the services necessary to handle the data of clinical studies and treatment observation in full compliance with CFR 21, part 11 (as confirmed by internal GAMP4 validation).

Data Management

The highly qualified and motivated team has more than three decades of experience in services related to submitting clients’ drugs for regulatory approval and delivering continuously high-quality data. Thanks to its flexibility and experience, CRS can work to clients’ specific SOPs, its own SOPs, or a combination of the two. In addition, CRS is also familiar with integrating sponsor-specific templates.

All the services of the Data Management & Biometrics Department can of course be contracted separately.

Able to handle large quantities of data efficiently, CRS’s highly-qualified team supports data expertise in every phase of drug development such as collection, organisation, validation, analysis, and the quality control of clinical trial data.

CRS’s clients benefit from the flexible data management team consisting of mathematicians and statisticians aided by IT specialists and clinical data managers. The team works on at least 60 trials per year from Phases I-IV and is used to handle and evaluate data in all relevant formats. As a result, CRS complies with project schedules while meeting the highest standards of quality in the most efficient, cost-effective manner.

Biometrics

The experienced, well-trained Biostatistical Department at CRS provides statistical analysis and programming adhering to both clients’ project requirements and ICH E9 guideline for successful trial evaluation.

In addition, attention is paid to process optimisation while focusing on maximum results. Data analysis is performed using industry-standard SAS® software as well as Testimate, WinNonlin and nQuery Advisor.

Implemented Software

  • Data management system: Oracle Clinical (Version 4.52)
  • Sample size calculation: n-query Advisor
  • Evaluation: SAS, Testimate, WinNonlin for SAS users

The software used (SAS, Oracle Clinical) is fully validated, ensuring that every phase of your trial is correctly focused for maximum results.

An important part of CRS’s range of services is to deliver study data and report it in the form of electronic Common Technical Documents (eCTD) complying with the standards imposed by international authorities.

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