Pharma Data Associates
Pharma Data Associates is a company of statisticians, SAS programmers, and clinical data managers with extensive experience supporting clinical development in biopharmaceutical companies and government agencies. Their mission is to provide high-quality, flexible, and results-oriented biometrics support as an extension of their clients' teams, ensuring regulatory compliance and efficient data management. They offer a wide range of biostatistics, data management, and regulatory submission services, with a focus on FDA eSubmission standards and CDISC compliance.
Industries
Nr. of Employees
small (1-50)
Pharma Data Associates
Piscataway, New Jersey, United States, North America
Services
Comprehensive biostatistics services including trial design, power/sample-size calculations, SAP development, interim analyses, mock TLFs, and CSR review.
Mapping raw clinical data to SDTM, creation of ADaM datasets and Define.xml, assembly of eSubmission folder structures and XPT datasets compliant with FDA requirements.
eCRF and CRF design, edit-check specification, UAT, data management planning, query resolution, external data reconciliation, SAE reconciliation, metric reporting and database lock.
SAS programming for TLFs, analysis dataset generation, and development of graphical tools such as patient profile plots and forest plots to aid safety and efficacy review.
Consulting on adaptive and group-sequential designs, Bayesian stopping rules, conditional power calculations, and sample-size re-estimation to optimize trial duration and cost.
Comprehensive biostatistics services including trial design, power/sample-size calculations, SAP development, interim analyses, mock TLFs, and CSR review.
Mapping raw clinical data to SDTM, creation of ADaM datasets and Define.xml, assembly of eSubmission folder structures and XPT datasets compliant with FDA requirements.
eCRF and CRF design, edit-check specification, UAT, data management planning, query resolution, external data reconciliation, SAE reconciliation, metric reporting and database lock.
SAS programming for TLFs, analysis dataset generation, and development of graphical tools such as patient profile plots and forest plots to aid safety and efficacy review.
Consulting on adaptive and group-sequential designs, Bayesian stopping rules, conditional power calculations, and sample-size re-estimation to optimize trial duration and cost.
Expertise Areas
- Clinical trial biostatistics
- Statistical programming (SAS)
- Clinical data management and EDC/CDASH
- CDISC standards and FDA eSubmission preparation
Key Technologies
- SAS programming
- CDISC SDTM
- CDISC ADaM
- Define.xml
News & Updates
Rescue Mission for an NDA Submission
NDA re-prepared with amended phase 3 CSRs, new ISS, and new statistics data package compliant to the FDA eSubmission requirement, completed in 2.5 months.
Cost Savings as a Result of Sample Size Reduction
Early termination of trials using Bayesian methods, resulting in 50% cost saving, and sample size re-estimation reducing trial length by 30%.
Consideration in Study Design
Mid-course modification of a group sequential trial and a non-inferiority study design for a cardiovascular drug with MACE endpoint.
Rescue Mission for an NDA Submission
NDA re-prepared with amended phase 3 CSRs, new ISS, and new statistics data package compliant to the FDA eSubmission requirement, completed in 2.5 months.
Cost Savings as a Result of Sample Size Reduction
Early termination of trials using Bayesian methods, resulting in 50% cost saving, and sample size re-estimation reducing trial length by 30%.
Consideration in Study Design
Mid-course modification of a group sequential trial and a non-inferiority study design for a cardiovascular drug with MACE endpoint.