Biometrics

Introduction

We have extensive knowledge and experience across the full range of Biometrics services:

  • Database Set-up
  • Data Management
  • Statistical Analysis and Reporting
  • Regulatory Submission Support
  • Pharmacovigilance

We offer a wide range of services for individual clinical studies through to statistical consultancy to integrated databases and regulatory submissions support.  

Our CDISC knowledge is one of the cornerstones of our biometrics capabilities, combined with a strong team of statisticians and SAS programmers.

Many of our consultants work on-site as integrated members of client teams.  We also offer full-service integrated biometric services from our UK office (database, data management, and statistical reporting) and statisticians to provide statistical consultancy support. 

Statistical Programming

S-cubed’s team of 25+ SAS/statistical programming specialists has converted over 100 studies to CDISC standards and supported more than 20 successful FDA submissions. Our highly experienced consultants are all well trained in CDISC standards and all versions of SAS software across many platforms.

With in-depth knowledge of the clinical trial process, we can provide comprehensive and effective SAS programming support to the Pharmaceutical and Healthcare sector.

Specialties

  • Statistical Programming - Derived data creation, generic macro development, statistician support, TFL production, submission preparation
  • CDISC Programming - Fully up-to- date on requirements and experienced producing SDTM and ADaM in a variety of environments
  • Data Conversion and Integration - Legacy and non-standard data conversion and database integration
  • Program Overhaul - Efficiency improvement, validation and documentation
  • General SAS support

Statistical Analysis

Our statisticians provide statistical consultancy support and have expertise across the full range of statistical activities needed to progress a product through the drug development process. We have extensive experience of working with small early-stage biotech companies as well as large international pharmaceutical organisations.

At S-cubed we have a strong focus on accuracy and clarity, whilst still offering a tailored, collaborative service with a quick turnaround, allowing our clients to keep reporting timelines and costs to a minimum. Providing a comprehensive statistical service, we are experienced in attending regulatory agency meetings throughout the world and have experienced many successful client and regulatory audits.

Specialties

  • Study Design - Statistical input for study design and protocols, clinical development plans, sample sizing, randomisation and statistical analysis plans
  • Study Reporting - TFL production, interim analysis, pharmacokinetic analysis and statistical report writing
  • Post-hoc Analysis - Provision of post-hoc and/or exploratory ad-hoc clinical trial analysis and advice
  • Submission Preparation - ISS, ISE and CDISC integrated datasets for electronic submissions (eCTD)
  • DSMB - Participation as an independent statistician on DSMBs, including preparation of charters and analyses
  • Regulatory Meetings - Preparation and attendance at agency meetings
  • Statistical Support - Wide range of additional services, such as Biometrics project management, independent quality control of statistical activities, statistical due diligence (e.g. in-licencing of drugs), journal manuscript input and review, and advice on processes and audit

Clinical Data Management

S-cubed performs the full suite of Data Management services from planning and documentation (Data Management Plan and Data Validation Plan), CRF (EDC or paper) design and testing, Diary Card and database design, double data entry, discrepancy management, medical coding, SAE reconciliation, database lock. S-cubed can perform all of these services for a client or act in a consultancy basis on particular aspects.

Our Data Management staff have a vast amount of experience on a variety of database systems and are happy to work on a client’s preferred database solution or provide S-cubed’s solution.

OpenClinica

S-cubed’s clinical database solution is OpenClinica. OpenClinica has a large user community (>18,000 people) in over 100 countries, and is used by a wide variety of pharmaceutical, biotech and device companies. It is a user-friendly fully validated 21 CFR Part 11 compliant internet-based system which can be accessed via a range of devices. OpenClinica allows electronic data capture at clinical sites as well as traditional paper entry (or a hybrid approach). OpenClinica also has an ePRO capability with subjects able to enter data (e.g. Questionnaires) directly onto the database via their smart phones or other mobile devices.

Scott McGregor

Title: Managing Director & SAS Solution Specialist
Location: Denmark

Mark Baillet

Title: Managing Director & Consultant Statistician
Location: UK