Pharmapace, Inc.
Home
About Us
  • Who Are We?
  • Leadership
  • Core Business
  • Therapeutic Experience
  • How We Manage Your Data
  • Drugs We Helped Approved
  • Events & Impact
  • Publications
Services
  • Biostatistics
  • Data Management
  • Statistical Programming
  • CDISC (SDTM/ADaM)
  • Regulatory Submissions
  • Clinical Data Integration
  • ClinicalTrials.gov Submit
  • Medical Writing
  • FSP
  • BIMO
  • PK/PD Analysis
  • Project Management
Contact Us
Pharmapace, Inc.
Home
About Us
  • Who Are We?
  • Leadership
  • Core Business
  • Therapeutic Experience
  • How We Manage Your Data
  • Drugs We Helped Approved
  • Events & Impact
  • Publications
Services
  • Biostatistics
  • Data Management
  • Statistical Programming
  • CDISC (SDTM/ADaM)
  • Regulatory Submissions
  • Clinical Data Integration
  • ClinicalTrials.gov Submit
  • Medical Writing
  • FSP
  • BIMO
  • PK/PD Analysis
  • Project Management
Contact Us
More
  • Home
  • About Us
    • Who Are We?
    • Leadership
    • Core Business
    • Therapeutic Experience
    • How We Manage Your Data
    • Drugs We Helped Approved
    • Events & Impact
    • Publications
  • Services
    • Biostatistics
    • Data Management
    • Statistical Programming
    • CDISC (SDTM/ADaM)
    • Regulatory Submissions
    • Clinical Data Integration
    • ClinicalTrials.gov Submit
    • Medical Writing
    • FSP
    • BIMO
    • PK/PD Analysis
    • Project Management
  • Contact Us
  • Home
  • About Us
    • Who Are We?
    • Leadership
    • Core Business
    • Therapeutic Experience
    • How We Manage Your Data
    • Drugs We Helped Approved
    • Events & Impact
    • Publications
  • Services
    • Biostatistics
    • Data Management
    • Statistical Programming
    • CDISC (SDTM/ADaM)
    • Regulatory Submissions
    • Clinical Data Integration
    • ClinicalTrials.gov Submit
    • Medical Writing
    • FSP
    • BIMO
    • PK/PD Analysis
    • Project Management
  • Contact Us

Our Services

Biostatistics

Statistical & Database Programming

Data Management

We provides expert biostatistics support for clinical trials, ensuring rigorous study design, accurate data analysis, and regulatory compliance. Our team specializes in statistical strategy, protocol development, adaptive trial designs, and regulatory submissions to maximize the success of your drug development program.





Learn More

Data Management

Statistical & Database Programming

Data Management

 We ensures high-quality, regulatory-compliant data management from trial design to study close. Our expert team delivers accurate, on-time results while maintaining rigorous FDA and EMA standards, including 21 CFR Part 11 and ICH-GCP compliance. We specialize in eCRF design, database builds, data review, query management, and database lock, ensuring seamless clinical trial execution.



Learn More

Statistical & Database Programming

Statistical & Database Programming

CDISC, SDTM, and ADaM Compliance

 We leverages cutting-edge technology and metadata-driven tools to ensure high-quality, efficient, and cost-effective clinical and statistical programming. Our expert programmers deliver fully compliant datasets for regulatory submissions, supporting diverse therapeutic areas such as oncology, metabolic diseases, neurosciences, and cardiovascular conditions. Services include SDTM and ADaM creation, FDA advisory committee analyses, clinical study reporting, and risk-based study monitoring.

Learn More

CDISC, SDTM, and ADaM Compliance

Regulatory Submissions (FDA NDA / EMA MAA)

CDISC, SDTM, and ADaM Compliance

 We ensures seamless regulatory submissions by delivering fully CDISC-compliant data packages. With expertise in SEND, SDTM, and ADaM standards, we streamline data mapping, validation, and submission processes, supporting over 200 studies with high-quality, submission-ready datasets.


Learn More

Regulatory Submissions (FDA NDA / EMA MAA)

Regulatory Submissions (FDA NDA / EMA MAA)

Regulatory Submissions (FDA NDA / EMA MAA)

 We provides end-to-end support for regulatory submissions, ensuring compliance with FDA and EMA requirements. Our team specializes in preparing high-quality NDA and MAA submission packages, including statistical analyses, integrated summaries, and CDISC-compliant datasets to facilitate a smooth regulatory review process.


Learn More

Clinical Data Integration

Regulatory Submissions (FDA NDA / EMA MAA)

Regulatory Submissions (FDA NDA / EMA MAA)

 We specializes in building Global Integrated Databases (GIDB) to standardize clinical data, ensuring consistency across drug development programs. A well-structured GIDB streamlines regulatory responses, safety surveillance, market analysis, and future trial planning—maximizing the value of your clinical data while accelerating approvals and commercialization.

Learn More

ClinicalTrials.gov Publishing

Functional Service Provider (FSP)

ClinicalTrials.gov Publishing

 We ensures timely and accurate registration of your clinical trials on ClinicalTrials.gov, complying with all regulatory requirements. We manage protocol submissions, results reporting, and updates—helping sponsors maintain transparency, meet compliance deadlines, and support regulatory interactions.


Learn More

Medical Writing & Publications

Functional Service Provider (FSP)

ClinicalTrials.gov Publishing

 We offers comprehensive medical writing services throughout the drug development lifecycle, from Phase I to Phase IV, including clinical trial protocols, study reports, regulatory documents, and medical publications, all compliant with ICH guidelines and regulatory requirements.



Learn More

Functional Service Provider (FSP)

Functional Service Provider (FSP)

Functional Service Provider (FSP)

We offers flexible Functional Service Provider (FSP) solutions, providing experienced professionals in biostatistics, programming, and data management to support your clinical development needs.   

Our scalable model enables seamless team integration, whether on-site, remote, or hybrid, with performance tracking and long-term partnerships to ensure efficiency and continuity.

Learn More

Project Management

Project Management

Functional Service Provider (FSP)

 We provides expert project management services to ensure drug development studies are completed on time, within budget, and according to scope. Through proactive risk management, efficient resource allocation, and clear communication, we streamline all phases of the project, fostering long-term process improvements and sustainable success.

Learn More

BIMO

Project Management

PK/PD Analysis

We offers comprehensive BIMO services to ensure compliance with FDA regulations, including audit readiness, site inspection support, and documentation review to help you maintain the highest standards of data integrity and regulatory adherence.



Learn More

PK/PD Analysis

Project Management

PK/PD Analysis

We provides expert pharmacokinetic (PK) and pharmacodynamic (PD) analysis to support dose selection, efficacy evaluation, and safety assessments. Our team delivers high-quality, regulatory-compliant analyses to guide data-driven decisions throughout drug development.



Learn More

Statistics and Data Analytics For Your Clinical Trial

Core Business

65% - Clinical Trial Biometrics Outsourcing 


15% - Regulatory Submission


10% - Statistical Consulting     


5% - Global Integrated Database (GIDB)                                  


5% - Data & Analysis Rescue         

Our Therapeutic Experience

Cardiovascular

Central Nervous System (CNS)

Central Nervous System (CNS)

Central Nervous System (CNS)

Central Nervous System (CNS)

Central Nervous System (CNS)

Dermatology

Central Nervous System (CNS)

Endocrinology/Metabolic

Endocrinology/Metabolic

Endocrinology/Metabolic

Endocrinology/Metabolic

Gene Therapy

Endocrinology/Metabolic

Infectious Diseases

Infectious Diseases

Endocrinology/Metabolic

Infectious Diseases

Inflammatory/Immunology

NASH/NAFLD/Gastroenterology

NASH/NAFLD/Gastroenterology

NASH/NAFLD/Gastroenterology

NASH/NAFLD/Gastroenterology

NASH/NAFLD/Gastroenterology

Oncology

NASH/NAFLD/Gastroenterology

Ophthalmology

Ophthalmology

Rare/Orphan Diseases

Ophthalmology

Rare/Orphan Diseases

Rare/Orphan Diseases

Rare/Orphan Diseases

Respiratory

Rare/Orphan Diseases

Rare/Orphan Diseases

How We Manage Your Data

All data is securely stored on Pharmapace’s dedicated U.S.-based servers.

At Pharmapace, data security and integrity are paramount. All client information is securely stored on our dedicated, U.S.-based servers, with robust safeguards in place to ensure confidentiality, compliance, and uninterrupted access. Our centralized facilities are built to meet the highest industry standards—so your data stays protected, accessible, and audit-ready.


Our centralized facilities offer:


  • Daily backup & secure cloud storage
  • Weekly server structure backups
  • Centralized, validated SAS computing environment
  • Secure SharePoint and FTP access
  • Private, encrypted servers
  • Protected email communication system
  • Full compliance with 21 CFR Part 11


We’re committed to maintaining your trust by safeguarding your data every step of the way.

Contact us with any additional questions or to learn more about our data security practices.

Pharmapce, Inc. 

10509 Vista Sorrento Pkwy, Ste 303, San Diego, CA 92121

🇺🇸 

Proud U.S.-Based Company. 

Proud U.S.-Based Team. 

Proud U.S.-Based Servers.  

  • Home
  • Leadership
  • Core Business
  • Contact Us

Copyright © 2025 Pharmapace - All Rights Reserved.

This website uses cookies.

We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.

Accept