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Early Clinical Biometrics

We customise database services based on your needs and preferred processes in all phases of clinical trials and pre-clinical studies

Early phase biometrics, to include data management, programming, biostatistics and medical writing, are tailored to each client and supported by integrated teams with expertise in managing all facets of phase I studies as well as FIH trials, dose escalations and data safety reviews.

Dedicated phase 1-2a data management service

  • Medidata Rave primary EDC platform
  • Lean and flexible data delivery model
  • Start up and close out activities
  • Safety review timeline planning

Cross-functional programming engagement to improve quality

  • Support provided from data extract through eSubmission-ready deliverables
  • Defined SOPs with high focus on quality
  • Single point of contact for all programming study needs

Biostatistics

  • Integrated services
  • Accelerated workstreams
  • Cross functional team dedicated to early phase trials
  • Access to 250 biostatisticians

Medical writing

  • Standard protocol development and standard CSR development processes
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