Biometrics

At ExperTrials, we work with preferred partners in data management and biostatistics in order to advise and support all aspects of data capture and analysis from protocol and eCRF design through to database lock.

Biostatistics, Medical Writing, Clinical Data Management, central laboratory

Data Management

Data management services at ExperTrials are designed to make the process of design, collection, reconciliation, and review of clinical research data more efficient and reliable. We know how to make EDC technology and surrounding processes work to ensure the integrity of every data set. Minimizing the risks associated with EDC and clinical data management, our data managers help you capture clean and accurate clinical research data while meeting key and aggressive project deadlines. For sponsors, this equates to less time training for each project and more time running efficient trials. Although our clinical data specialists manage all of the data, you stay in complete control with continuous access to data and total transparency to study progress.

Our services include :
  • CRF design and development
  • Data base build and validation
  • Biomarker analysis
  • CDISC SDTM conversion
  • PK and PD modeling
  • Risk-based monitoring
  • RTSM
  • CDASH standard datasets
  • Data entry
  • Extensive edit checking
  • Clinical Team and Site training, mentoring and support with EDC
  • Site metrics for CRF completion and Query Resolution
  • Continual Quality Control review including audit trail logging
  • MedDRA and WHO Drug coding
  • Interim analysis
  • Clinical Study Report

Biostatistics

At ExperTrials, we support you in the planning, design and analysis of your clinical trial programme. Regardless of the complexity of your project, ExperTrials provides expert statistical solutions and experienced technical advices.

Our services include :

  • Independent data monitoring committees (IDMC)
  • PK and PD modelling
  • Biomarker analysis
  • Functional Service Provider
  • SAP redaction
  • Statistical analysis
  • ISS and ISE analysis
  • Bayesian statistics
  • Futility analysis
  • QOL scale development

Sometimes you simply need assistance in a particular functional area

All our partners operate in full compliance with all applicable regulations, including GCP and FDA 21 CFR, part 11. ExperTrials will be your single point of contact for all aspects of your trial.

Get in touch with us and let’s start your project !

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