Statistical/Clinical SAS Analysis Expertise

  Configer Technologies statistical services are composed of experienced Ph.D. and M.S. level of Statisticians/ Biostatisticians, SAS Certified (Base and Advanced) Programmers.
Our efficient, experienced and skilled staff is expert in the design and analysis of Phase I to IV clinical trials with varying designs, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/ pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs. Configer Technologies Statisticians are highly skilled in every aspect of experimental design and are also able to determine study objectives and develop Statistical Analysis Plans (SAPs).

 Our statistical services include:
  • Protocol Review and Development
  • Study design and analysis planning
  • Statistical Analysis Plan (SAP)
  • Central randomization (paper or electronic)
  • ISS & ISE preparation and DSMB support
  • Table & Listing validation and Quality Control
  • Complete final analysis (Phase I to IV)
  • Interim & meta-analysis
  • Ad-hoc and exploratory statistical analysis
  • Statistical consulting

    Our SAS Programming/Analysis services include:
  • Table, Listings and Figures Programming
  • Analysis Dataset Programming and Documentation
  • Patient Profiles & Ad-hoc reports
  • CDISC (SDTM & ADaM) mapping
  • CRF Annotation
  • Regulatory E-Sub Deliverables-Preparation and QC

CDISC Compliance Expertise

Configer Technologies has extensive experience in helping its customers become CDISC compliant. We have worked on large and small CDISC specific projects, some involving only consultancy and others involving mapping of multiple studies to CDISC standards.

 Our services include:
  • Creation of customized CDISC solutions
  • Building new CDISC SDTM compliant databases
  • Creation of CDISC SDTM domains from various customer-defined data standards
  • Mapping of studies from legacy to CDISC standards for ISS/ISE
  • reporting and FDA submission
  • Converting CDISC ODM XML to SAS datasets and vice versa
  • Creation of the 'Case Report Tabulation Data Definition
  • Specification', (DEFINE.XML) for submission to the FDA
  • Statistical programming using ADaM derived datasets as inputs to the SAS report code

Clinical, Healthcare & IT Staffing Services
  We at Configer Technologies employ a unique and effective recruiting strategy, which has the capability to reach not only the national resource pool but also the international resource pool of talent. With our sophisticated and finely tuned requirement-to-resource matching procedure, we provide our clients with professionals who match their needs in most cost-effective way.

Data Management Expertise

Configer Technologies dedicated Data Management experts provide accurate, regulatory-compliant clinical data solutions.

  • Paper
  • Fax, or
  • EDC - Electronic Data Capture
Our data management services and procedures include:
  • Data Management Plan (Quality Control Guidelines)
  • Case Report Form (CRF) Design
  • Database design and Data Validation plan
  • Quality control testing of database
  • Data entry (double)
  • Data clarification, consistency/logic checks and querying
  • Medical Coding - MedDRA, WHO - ART, COSTART, WHODRUG
  • Data Validation and Query Management
  • Central laboratory data import
  • Data lock, audit and export (SAS, ASCII, etc.)
  • Database Documentation and Release

 To ensure the integrity and accuracy of the study data, our Data Management Staff follow corporate QC and QA processes. Our QA process formally assesses compliance with corporate and study-specific SOPs.
Our Data Management platforms are based on Oracle Clinical. All of our systems and software platforms are fully validated and comply with ICH Guidelines and current US, EU and Canadian government regulations.

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