Biometrics

Biostatistics

Exciting innovations in data analysis and visualizations are paving the way for a better clinical experience. Advanced Clinical provides comprehensive, results-driven services in Biostatistics and SAS Programming. Our knowledgeable team closely coordinates with the Sponsor and other functional areas to increase quality, shorten timelines, and help you execute your unique trial in order to make better data-driven decisions sooner.

We base our recommendations on over 20 years of experience in clinical trials. With our expertise and guidance in adaptive designs and integrated analyses, clients can reduce the time to regulatory submission and marketing approval. Our Biometrics team has provided support for hundreds of studies across all major therapeutic areas, and has submitted eight regulatory filings in the past eight years.

Advanced Clinical is a long-time member of CDISC, PhUSE, DIA, and ASA. Our Director of Biostatistics has over 18 years of experience and our Program Biostatistician has over 25 years of statistical consulting experience including publishing over 60 articles in multiple therapeutics areas.

BIOSTATISTICS SERVICES

  • DSMB/DMC and Clinical Events Committee support
  • Statistical analysis plans
  • Protocol, case report form, and clinical study report review
  • Randomization schedules
  • Planning and implementing interim analyses
  • NDA: Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
  • FDA and other regulatory interactions, including Advisory Committee meetings
  • Publication support and ad hoc analyses
  • Statistical consulting

SAS PROGRAMMING SERVICES

  • CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
  • Experience with multiple EDC platforms
  • Derived dataset production and validation
  • TLF production and validation
  • Regulatory submissions (Development of integrated ADaM datasets for ISS/ISE analyses, Define.XML)
  • Submission-ready datasets and programs
  • Study rescue and legacy data requests

DATA MANAGEMENT

Our Data Management team is flexible, collaborative and built to produce. Advanced Clinical uses years of experience, problem solving approach, and value-added technologies to help our clients achieve faster study start-up times, shorter time to database lock, and make the overall data management experience a better clinical experience.

We’re equipped to address even the most rigorous timelines and the most complex data integrations. Our time-tested and industry-proven SOPs and templates provide the robust basis from which we repeatedly deliver on-time results with the highest of quality.

We are active at various levels in the Society for Clinical Data Management (SCDM) and strive to stay up to date with the latest methods and regulations. Our Director brings over 20 years of industry experience and our Data Management team averages over 12 years of experience.

Our Data Managers and Database Programmers have depth of experience using a wide range of electronic data capture (EDC) systems, and have experience with electronic diaries and ePRO technologies. We work closely with our sponsors to gain insights into needs and provide system recommendations based on the size, scope, and complexity of your clinical trial. Once the appropriate systems are selected, we work to ensure that systems are customized to the sponsor and their clinical trial.

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