Pharmapace
Pharmapace, Inc. is a premier U.S.-based clinical research organization (CRO) founded in 2013, specializing in high-quality consulting and outsourcing services across all stages of drug development and post-marketing support. The company is committed to operational and scientific excellence, providing tailored solutions in biostatistics, data management, regulatory submissions, clinical data integration, medical writing, and project management. With a focus on regulatory compliance, data security, and industry-leading expertise, Pharmapace aims to support clients in advancing human health through comprehensive and reliable clinical development solutions.
Industries
Nr. of Employees
small (1-50)
Pharmapace
San Diego, California, United States, North America
Services
Statistical strategy, trial design, SAPs, adaptive designs, interim analyses, DMC support, meta-analysis, predictive analytics and statistical reporting across clinical phases.
End-to-end clinical data management including eCRF design, EDC database build, UAT, edit checks, query management, third-party reconciliation, coding management, and database lock.
Metadata-driven programming to produce SDTM, ADaM and SEND datasets, define.xml and submission-ready SAS transport files with QC and validation.
Preparation of regulatory submission components including integrated summaries, statistical analyses, and coordination of eCTD-ready data packages for FDA and EMA.
Design and implementation of global integrated databases to standardize clinical data and enable regulatory responses, meta-analyses, safety surveillance, and lifecycle analytics.
Scalable resourcing model providing dedicated or shared statisticians, programmers and data managers with on-site, remote, or hybrid deployment and performance metrics.
Statistical strategy, trial design, SAPs, adaptive designs, interim analyses, DMC support, meta-analysis, predictive analytics and statistical reporting across clinical phases.
End-to-end clinical data management including eCRF design, EDC database build, UAT, edit checks, query management, third-party reconciliation, coding management, and database lock.
Metadata-driven programming to produce SDTM, ADaM and SEND datasets, define.xml and submission-ready SAS transport files with QC and validation.
Preparation of regulatory submission components including integrated summaries, statistical analyses, and coordination of eCTD-ready data packages for FDA and EMA.
Design and implementation of global integrated databases to standardize clinical data and enable regulatory responses, meta-analyses, safety surveillance, and lifecycle analytics.
Scalable resourcing model providing dedicated or shared statisticians, programmers and data managers with on-site, remote, or hybrid deployment and performance metrics.
Expertise Areas
- Clinical trial biometrics
- Biostatistics and statistical consulting
- Clinical data management and EDC
- CDISC standards implementation (SDTM/ADaM/SEND)
Key Technologies
- CDISC standards (SDTM, ADaM, SEND)
- SAS validated computing environment
- EDC and eCRF systems
- Define.xml and data reviewer’s guide generation
News & Updates
2025 Biostatistics Symposium of Southern California
Pharmapace served as the Diamond and Founding Sponsor of the inaugural BSSC, bringing together over 250 professionals to shape the future of life sciences through data analytics, innovation, and collaboration.
Proud Diamond Sponsor of SoCal Biostatistics Symposium 2025
Pharmapace's support and leadership at the symposium fostered innovation, collaboration, and professional growth in biostatistics.
Pharmapace Celebrates Independence
Event celebrating the company's achievements and commitment to data-driven healthcare.
A Biometrika article authored by LZ Shen and J O’QUIGLEY on statistical methodology.
A study published in Diabetes insights on the effects of synthetic exendin-4.
A dose-ranging study published in Diabetes by Poon et al.
2025 Biostatistics Symposium of Southern California
Pharmapace served as the Diamond and Founding Sponsor of the inaugural BSSC, bringing together over 250 professionals to shape the future of life sciences through data analytics, innovation, and collaboration.
Proud Diamond Sponsor of SoCal Biostatistics Symposium 2025
Pharmapace's support and leadership at the symposium fostered innovation, collaboration, and professional growth in biostatistics.
Pharmapace Celebrates Independence
Event celebrating the company's achievements and commitment to data-driven healthcare.
A Biometrika article authored by LZ Shen and J O’QUIGLEY on statistical methodology.
A study published in Diabetes insights on the effects of synthetic exendin-4.
A dose-ranging study published in Diabetes by Poon et al.