Biometrics

Biometrics

Delivering high quality data management, superior statistics, and expert report writing, we are responsive, flexible, and knowledgeable in our approach so you can have complete confidence in your data for the entire duration of drug development. We undertake each study with two main goals in mind – helping you design the right study and correctly preparing your statistical data for submission within your time requirements.

 

Data Management

Our data management team provides high-quality collection, organization, validation, analysis, and quality control of clinical trial data and utilizes electronic source records (ESR), electronic data capture (EDC) or paper, to expedite data collection. PHACT utilizes a number of different EDC platforms to meet your specific study and site requirements.

Working closely with Sponsor project teams, our data managers develop detailed specifications for the collection, organization, validation, analysis, and quality control of clinical trial data ensuring the most cost-effective, secure, and regulatory compliant process. Our responsive approach allows flexibility in accommodating changes to project specifications with minimal to no timeline adjustment, all while maintaining the highest levels of data quality and integrity.

 

Data Management services

  • Design of source documents and case report forms (CRFs), in either electronic or paper form.
  • Definition of edit checks and project-specific processes.
  • Validation of project-specific components of the data management system during the initial setup and throughout the trial as modifications are introduced.
  • Review of clinical data for errors or trends and generate electronic queries.
  • Integration of data from external sources to ensure consistency with CRF data.
  • Medical coding using standardized dictionaries such as MedDRA, WHO Drug, or Sponsor-specific dictionaries.
  • Delivery of a clean, analyzable database in customized formats, adhering to Clinical Data Interchange Standards Consortium (CDISC) standards.
  • Reconciliation of serious adverse events.

Biostatistics

Our experienced biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and reporting accuracy necessary to deliver your trial efficiently and on time. Data analysis is performed using industry-standard SAS® software, ensuring that every phase of your trial is correctly focused for maximum results.

 

Biostatistics Services

  • Comprehensive data analysis plans, including sample size determinations, detailed descriptions of statistical methodologies, program specifications, and mock examples of deliverables.
  • Generation of Randomization Schedules
  • Development of customized analysis programs thoroughly tested and validated according to documented procedures.
  • Interpretation of study results and writing support for the preparation of study reports.
  • Integrated efficacy and safety analysis for regulatory submissions, including electronic submissions.
  • Statistical support throughout – including regulatory agency meeting support.