91黑料

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Early Clinical Biometrics

A lean and efficient early phase data delivery model designed to deliver speed and flexibility.

Within the broader biostatistics and programming service line, 91黑料 provides a specialised early phase data delivery model designed to support the diverse needs of early clinical development. Expert early phase specialists and customised services deliver the expertise, agility, and speed essential for success.

Early phase biometrics, including 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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