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Clinical Trial Data Management & Biometrics Services

Supporting drug development

Simbec-Orion provides expert clinical trial data management, delivering accurate and adaptive biometrics services to support the success of drug development programmes. Our biometrics team conduct statistical analysis, planning and reporting across all clinical phases, creating a quality biostatistical framework that presents clinical trial data clearly and correctly for regulatory agencies.

Our clinical data management systems

Our biometrics expertise is complemented by the use of fully validated FDA and EMA compliant electronic data management systems, including Veeva Vault for eTMF and CTMS, as well as Oracle® Inform, which is amongst the preferred solutions as an electronic Case Report Form (eCRF) system.  We also have experience in other electronic data capture (eDC) platforms having utilised 6 different eCRF platforms in the last 3 years (including Medidata Rave, Viedoc, Datatrak, and Medrio). We are happy to undertake work in those systems if that is your preferred option.

The clinical data collection process

We devise a full statistical analysis plan for your clinical study, from planning, analysis to reporting. The process begins with:

  • Case Report Form (CRF) design and development of the eCRF database, including integration from third party sources, central laboratory, central ECG, electronic Patient-Reported Outcomes (ePRO).
  • Data collection proceeds with continuous data management and data cleansing, with electronic and manual checks on the data to detect inconsistencies. Serious Adverse Events (SAE) are captured in the database.
  • Medical coding is supported by built-in eCRF reports and targeted data listings generated and validated by Simbec-Orion group programmers. All programming is performed in SAS® under Git version control ensuring a reliable code base.

Adaptive clinical trial analysis

Our clinical data management team customise each tool to the specific study during set-up to ensure they are live prior to First Patient In and are described in the respective specifications and Study Plans. Statistical reporting is adapted to individual client requirements, providing an accurately tailored clinical trial data management service.

Full clinical study reporting

The clinical data management process is followed by medical monitoring and review, identifying protocol deviations to ensure consistency with endpoints and confirm that adverse events are well recorded and followed up.

Here, we can pool or merge databases, facilitating smooth clinical data migration between database schemes and verifying the data integrity. We then create a report for the collected data, writing the statistical sections of protocols through to medical writing for the integrated Clinical Study report.

Biostatistics and statistical programming

We have extensive experience with Biostatistics Services and Statistical programming, bringing full statistical support to customers. From elaborating study and database design to sample size determination and power calculation, we provide full statistical consulting across your phase I to phase III clinical trial data.

Our experts are experienced in working with data safety boards, conducting, and planning for adaptive trial designs and consultation

 

CDISC-compliant standards

Our clinical data management process complies with industry recognised Study Data Tabulation Model (STDM) or Clinical Data Interchange Standards Consortium (CDISC) standards. This allows for quality and accurate clinical trial data management, enabling rapid development, efficient review processes and seamless transfer of tasks between developers.

Let’s collaborate

If you think we could be right for you, get in touch.

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