Services

Statistical Analysis and Consultancy


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Biostatistical support throughout your project’s life-cycle

A qualified centralized team of clinical IT, data management, statistical and pharmacovigilance experts collaborating with you wherever you are. Our team has experience in all phases of clinical development, across a wide range of therapeutic areas. It ensures innovative approaches to the study design and statistical methodology to increase the chances of a successful trial.

OPIS CLINICAL.NET

Our biostatisticians and data managers play a pivotal role in the success of your clinical trial management. Statistical and data management expertise in combination with proprietary digital platforms, allows for planning, analysing and reporting of all phases of drug development.

Biostatistical support throughout your project’s life-cycle

OPIS offers a wide range of statistical services. Our biostatisticians combine a broad expertise on clinical studies with advanced skills in SAS® programming and provide their support during the whole course of clinical trials:

  • Support for protocol development, study design and sample size estimation
  • Randomization services, including IWRS/IVRS
  • Blinding/unblinding management, including production of emergency unblinding envelopes.
  • Statistical analysis plan, including output shells
  • Statistical programming using SAS®
  • Statistical analyses; tables/listings/figures for clinical study reports (CSRs)
  • Statistical results interpretation and presentation
  • SDTM and ADaM dataset preparation and validation (submission ready dataset packages)
  • Adaptive designs and Interim Analyses for early decision making
  • Support for Steering Committees and Data Monitoring Committees
  • Support for regulatory submissions
  • Support for CSR and publications

Regulatory
Trial Start-Up
Study Management and Monitoring
Data Management
SAS Programming
Statistical Analysis and Consultancy
Pharmacovigilance
Quality Assurance
Medical Affairs and Medical Writing
Preclinical and drug development consultancy
Project Control
e-Clinical Patform - OPIS CLINICAL.NET