Biostatistics & Data Management

Advance your study with expert study design, optimized data collection, and comprehensive insights.

Delivering superior biostatistical and data management services for unmatched data accuracy

Overview

At Premier Research, we understand that the success of any trial is measured by data quality. Our biostatistics and data management professionals begin with this end in mind – incorporating efficiencies throughout a project and tailoring needs to meet desired outcomes. Our comprehensive services assure optimized trial design, regulatory compliance, and data integrity. We prioritize the seamless flow of quality data from study design through submission.

Biostatistics

Our veteran biostatistics professionals work closely with you at every step, using technical, scientific, and industry expertise to support trial design, statistical analysis, and reporting. Early in study planning, they work collaboratively with cross-functional project teams to offer guidance on sample size, randomization methods, and clinical endpoints.  We offer:

  • International staff who optimize regulatory-compliant and cost-effective methods of collecting, analyzing, and presenting both interim and final analysis results
  • Comprehensive clinical development planning from protocol design and sample size calculation through clinical study report (CSR) writing and review
  • Cross-functional integration throughout the full project plan, including database design and setup, and report development
  • Advanced knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards and requirements to ensure new drug application (NDA) submission-ready data
  • Extensive proficiency in data and safety monitoring board (DSMB) output, interim analysis, and investigational new drug (IND) safety updates
  • Deep and varied regulatory filing experience spanning dermatology, a variety of rare/orphan diseases, oncology, central nervous system, gastrointestinal, and medical device

Data Management

Our seasoned data management experts provide a full complement of services to ensure accurate data collection, validation, and cleaning. We strive to quickly address any issue that arises, providing clean, robust data to guide your drug swiftly through development. Our data management team will:

  • Design, develop, and validate the study database based on study specifications
  • Develop case report forms in accordance with all regulatory and study requirements
  • Carryout rigorous data cleaning procedures to ensure data accuracy and completeness
  • Support medical coding and reconcile serious adverse events

Support from Premier IRT

Our data management and biostatistics teams are supported by our Premier IRT (Interactive Response Technology) system that simplifies clinical trial management, improves data security, and easily accommodates your specific study design requirements, offering:

  • Interactive Voice Response System (IVRS): Voice-based IRT system
  • Interactive Web Response System (IWRS): Web-based IRT system
  • Electronic Clinical Outcome Assessment (eCOA) Solution: IVRS + IWRS + reporting device of your choice for electronic patient-reported outcomes (ePROs) and other clinical assessments

Our reliable, fully validated 21 CFR Part 11-compliant IVRS/IWRS system allows you to automate many aspects of your trial with flexibility and confidence. That means less stress on investigators and patients alike, and it lets you focus.

Click here to learn more about the core of our IRT system within the Remarque Integration HUB.

Insights

Agility and knowledge at your fingertips

Perspectives Blog

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

Progress in advanced computational methods using modeling and simulation has been enabled by advancements in computing technologies and the rise of artificial intelligence and machine learning.
White Paper

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer.

resources

Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.

Browse All Premier Resources

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