Pharmapace
Pharmapace is a private, San Diego-based biometrics CRO founded in 2013 that provides biostatistics, statistical programming, data management, CDISC, regulatory submissions, and FSP staffing services to biopharmaceutical companies, recently re-acquired by its founders via management buy-out from WuXi AppTec.
- Company typePrivate
- Founded2013
- HeadquartersSan Diego, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Pharmapace does
Pharmapace, Inc. is a private biometrics Clinical Research Organization (CRO) founded in 2013 and headquartered at 7220 Trade St, STE 180 in San Diego's Sorrento Valley. The company provides a suite of 12 interconnected clinical development services to biopharmaceutical clients, spanning biostatistics, data management, statistical programming, CDISC (SDTM/ADaM) compliance, regulatory submissions (FDA NDA and EMA MAA), clinical data integration via a proprietary Global Integrated Database (GIDB), ClinicalTrials.gov registration, medical writing, Functional Service Provider (FSP) staffing, BIMO audit support, PK/PD analysis, and project management. Its technology backbone is a centralized, validated SAS computing environment with 21 CFR Part 11 compliance, secure server infrastructure, and automated CDISC data mapping. The company is led by a Fellow of the American Statistical Association (CEO Dr. Larry Shen) and executives with 70+ combined years of sponsor-side experience at Amylin, BioMarin, Ultragenyx, Elan, Gilead, and Pfizer.
Pharmapace was acquired by WuXi AppTec in 2019 and was subsequently re-acquired by co-founder Dr. Larry Shen and the executive team through a management buy-out, returning the company to founder/management ownership. Revenue is generated primarily through professional services contracts, with clinical trial biometrics outsourcing at 65% of revenue, regulatory submission support at 15%, statistical consulting at 10%, and the balance from GIDB services, data and analysis rescue work, and FSP engagements. Pricing is quote-based rather than publicly disclosed, with service delivery executed via dedicated or shared FSP resources, on-site, remote, or hybrid staffing. GTM is enterprise field sales driven by RFP submissions, website-based consultation bookings, and a LinkedIn presence, targeting biotech and pharmaceutical sponsors with a reported 96% client return rate.
Customer acquisition centers on a single horizontal segment (biopharmaceutical companies), with the FSP model creating a managed-services revenue layer beyond project-based consulting. There is no public revenue, headcount, or funding data; the company is operationally active, hiring across multiple statistician levels ($80K-$210K compensation bands) and is led by an executive team that has collectively contributed to 10+ successful NDA approvals. AI/ML is referenced only in leadership biography language and is not yet a productized capability.
Pharmapace firmographics
Firmographics- Name
- Pharmapace
- Legal name
- Pharmapace, Inc.
- Website
- https://pharmapace.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Pharmapace is a private, San Diego-based biometrics CRO founded in 2013 that provides biostatistics, statistical programming, data management, CDISC, regulatory submissions, and FSP staffing services to biopharmaceutical companies, recently re-acquired by its founders via management buy-out from WuXi AppTec.
- Ownership category
- akta.pro rank
Pharmapace industry classification
Industry- Product category
- Clinical Research Organization (CRO) Services
- NAICS
- Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)
- akta.pro secondary industries
- Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB), Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD)
Keywords
Where Pharmapace is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Pharmapace business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Infrastructure, Marketing or Sales, Operations
Revenue model
- Clinical Trial Biometrics Outsourcing: Core CRO services providing biostatistics, data management, statistical programming, and related clinical trial support. Represents 65% of revenue.
- Regulatory Submission: FDA NDA and EMA MAA submission support services including SDTM/ADaM dataset preparation and statistical analysis reports. Represents 15% of revenue.
- Statistical Consulting: Expert statistical consulting for clinical study design, protocol development, and regulatory strategy. Represents 10% of revenue.
- Global Integrated Database (GIDB): Data integration and harmonization services. Represents 5% of revenue.
- Data & Analysis Rescue: Recovery and remediation services for troubled clinical data. Represents 5% of revenue.
- Functional Service Provider (FSP): Dedicated or shared resources in biostatistics, programming, and data management with scalable team deployment. Long-term functional partnerships model.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Annual | Statistician - Entry-level professional supporting study-level statistical activities |
| Other | Annual | Senior Statistician - Leadership role in planning and conducting data analyses |
| Other | Annual | Principal Statistician - Senior consulting role with regulatory submission leadership |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels3 records
Pharmapace product offering
Product offeringCore offering
Pharmapace is a biometrics Clinical Research Organization (CRO) providing outsourced biostatistics, statistical programming, data management, CDISC (SDTM/ADaM) compliance, and regulatory submission services for biopharmaceutical companies. It supports FDA NDA and EMA MAA filings through submission-ready datasets, statistical analysis reports, integrated summaries, and clinical data integration via its Global Integrated Database (GIDB). Services are delivered by sponsor-side experienced statisticians and programmers as project-based consulting or Functional Service Provider (FSP) engagements.
Product overview
Pharmapace is a best-in-class biometrics Clinical Research Organization (CRO) founded in 2013, providing a comprehensive suite of 12 interconnected consulting and outsourcing services for biopharmaceutical drug development. The core offering consists of Biostatistics Services, Data Management, Statistical Programming, CDISC Services (SDTM/ADaM), Regulatory Submissions (FDA NDA/EMA MAA), Clinical Data Integration (including Global Integrated Database/GIDB), ClinicalTrials.gov Submit, Medical Writing, Functional Service Provider (FSP), BIMO Services, PK/PD Analysis, and Project Management. These services are delivered by an executive team with over 20+ years of sponsor-side experience and contribute to regulatory submissions and drug approvals. The company operates from San Diego, serving biotech and pharmaceutical clients with 96% client return rate.
Differentiator
Problem solved
Functional benefit
Products and services
- Biostatistics Services Provides statistical strategy for clinical development and regulatory submissions including trial design from preclinical through Phase IV, protocol development, sample size calculations, adaptive designs, statistical analysis plans, and regulatory representation at FDA advisory committee meetings.
- Data Management Comprehensive clinical data management with embedded Risk-Based Quality Management (RBQM), eCRF design, EDC database build, edit checks, query management, third-party data reconciliation, terminology coding, and database lock and archive services.
- Statistical Programming Clinical programming including data strategy for regulatory submissions, FDA advisory committee meeting analyses, integrated summaries of safety/efficacy, tables/figures/listings, SDTM/ADaM creation with define.xml, CDISC compliance validation, data mining, and ClinicalTrials.gov publishing.
- CDISC (SDTM/ADaM) Services CDISC compliance consulting, legacy data transformation to CDISC-compliant formats, submission-ready SEND/SDTM/ADaM packages in SAS transport v5 format, define.xml and data reviewer guide creation, and CDASH-compliant eCRF database design.
- Regulatory Submissions Expert support for FDA NDA and EMA MAA from planning through approval, including submission-ready SDTM/ADaM datasets, statistical analysis reports, TLFs, reviewer guides, ISS/ISE documentation, eCTD/EMA formatting compliance, and BIMO inspection support.
- Clinical Data Integration Global Integrated Database (GIDB) development supporting regulatory responses, manuscripts, marketing materials, payer analyses, annual safety updates, pharmacovigilance surveillance, product lifecycle planning, meta-analyses, and exploratory analyses.
- ClinicalTrials.gov Submit Trial registration, results posting in FDAAA/NIH compliance, data formatting and QC checks, ongoing submission tracking, and liaison support for ClinicalTrials.gov communications.
- Medical Writing Manuscript writing and editing, abstract and poster development, journal selection and submission support, compliance with ICMJE and GPP guidelines, and coordination with authors and publication teams.
- Functional Service Provider (FSP) Dedicated or shared resources in biostatistics, programming, and data management with scalable team deployment, on-site/remote/hybrid staffing options, metrics tracking, and long-term functional partnerships.
- BIMO Services Audit readiness assessments, data traceability and documentation support, FDA BIMO compliance, validation of statistical outputs and programming, and regulatory inspection support.
- PK/PD Analysis Non-compartmental and compartmental PK analysis, PK/PD modeling and simulation, dose-response and exposure-response analysis, population PK/PD studies, and data interpretation for regulatory submissions.
- Project Management Expert project management driving quality, efficiency, and risk control across every phase; risk-driven project leadership; end-to-end study oversight; strategic project and risk management; and efficient timeline and resource allocation.
Companies that use Pharmapace
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles2 records
Pharmapace technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Pharmapace partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- WuXi AppTecmajorPharmapace was acquired by WuXi AppTec in 2019. Dr. Larry Shen served as President and CEO following the acquisition. Pharmapace has since been re-acquired through a management buy-out by Dr. Shen and his executive team.
Scale indicators7 records
Recent moves7 records
Expansion highlights5 records
Pharmapace competitors and assessment
Company assessmentEmerging players
- Celerion: Specialty early-phase clinical and bioanalytical CRO. Partially comparable to Pharmapace through PK/PD analysis and bioanalytical/biostatistics work, but anchored in Phase I rather than later-phase biometrics.
Broad incumbents
- Medpace: Mid-to-large full-service CRO with strong in-house biostatistics, data management, and regulatory capabilities. Comparable to Pharmapace in biometrics service line but competes as a broader, full-service Phase I–IV vendor.
- Parexel: Global full-service CRO with deep biostatistics, data management, and regulatory submission expertise. Comparable to Pharmapace in its biometrics and regulatory capabilities, but operating at a much larger enterprise scale.
- Worldwide Clinical Trials: Mid-size full-service CRO with deep biostatistics and data management practices focused on complex therapeutic areas. Overlaps with Pharmapace's biometrics and regulatory offering while also providing full-service clinical operations.
- IQVIA: Largest global CRO with end-to-end biometrics, data management, statistical programming, and regulatory submission services. Represents the dominant incumbent in the enterprise biometrics outsourcing market Pharmapace serves.
- Fortrea (formerly LabDrug Development): Large full-service CRO with extensive biostatistics, data management, and regulatory submission capabilities spun out from Labcorp. Represents the incumbent competitor Pharmapace faces in enterprise biometrics outsourcing.
Direct peers
- Cytel: Specialist biostatistics and statistical programming CRO serving biopharma sponsors. Directly comparable to Pharmapace as a biometrics-focused mid-size CRO with overlapping SDTM/ADaM, FSP, and regulatory submission offerings.
- Ergomed (now PrimeVigilance / Ergomed CRO): Mid-tier clinical and biometrics CRO with strong biostatistics, pharmacovigilance, and regulatory services. Comparable to Pharmapace in biometrics depth and focus on small/mid-cap biopharma sponsors.
- Tigermed (Hangzhou Tigermed): Asia-headquartered full-service CRO with significant biostatistics and data management practices serving global biopharma. Comparable to Pharmapace in biometrics and regulatory submission capabilities, with broader clinical reach.
- Clindatrix (Clinipace Worldwide): Mid-sized biometrics and clinical CRO serving small and mid-cap biopharma. Comparable to Pharmapace in size, sponsor base, and biometrics/regulatory submission services, including data management and biostatistics outsourcing.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Pharmapace social profiles
Digital presencePharmapace compliance and trust
Trust signalCompliance1 record
Pharmapace financial estimates
Financial estimateRevenue estimate
Valuation estimate
Pharmapace leadership team
Management profileNumber of profiles
Profiles7 records
Pharmapace funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Pharmapace M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Pharmapace
What does Pharmapace do?
Pharmapace is a biometrics Clinical Research Organization (CRO) providing outsourced biostatistics, statistical programming, data management, CDISC (SDTM/ADaM) compliance, and regulatory submission services for biopharmaceutical companies. It supports FDA NDA and EMA MAA filings through submission-ready datasets, statistical analysis reports, integrated summaries, and clinical data integration via its Global Integrated Database (GIDB). Services are delivered by sponsor-side experienced statisticians and programmers as project-based consulting or Functional Service Provider (FSP) engagements.
Is Pharmapace a public or private company?
Pharmapace is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Pharmapace founded?
Pharmapace was founded in 2013. It employs 11 to 50 people.
Where is Pharmapace based?
Pharmapace is headquartered in San Diego, United States, in the North America region.
How does Pharmapace make money?
Six revenue lines are on record. Clinical Trial Biometrics Outsourcing is the primary driver. The others are regulatory Submission, statistical Consulting, global Integrated Database (GIDB), data & Analysis Rescue and functional Service Provider (FSP).
Who are Pharmapace's main competitors?
Celerion is listed as an emerging player. Broad incumbents are Medpace, Parexel, Worldwide Clinical Trials, IQVIA and Fortrea (formerly LabDrug Development). Direct peers are Cytel, Ergomed (now PrimeVigilance / Ergomed CRO), Tigermed (Hangzhou Tigermed) and Clindatrix (Clinipace Worldwide).
Does Pharmapace have an API?
No public API is recorded for Pharmapace.
What industry is Pharmapace in?
Pharmapace's product category is Clinical Research Organization (CRO) Services. Its primary akta.pro industry code is HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs, with a secondary code of HLAGAAAG, Medical Writing & Regulatory Submission Support CROs. Its NAICS code is 5417 and its SIC code is 8731.