TradeCraft Clinical Research

What TradeCraft Clinical Research does

TradeCraft Clinical Research is a privately held, U.S.-based contract research organization (CRO) founded in 2014 in Wayne, Pennsylvania, that specializes in statistical programming and biostatistics for life sciences sponsors. The firm positions itself as an extension of the sponsor's team rather than a replacement, addressing a pain point it identifies around sponsors losing control of clinical trial data with large, offshore-heavy CROs. Its service portfolio covers SAS-based tables, figures, and listings (TLFs), SDTM and ADaM dataset implementation, statistical analysis plan authoring, clinical study reports, integrated summaries of safety/efficacy, and Functional Service Provider (FSP) staffing engagements. TradeCraft differentiates through a regulatory submission acceptance guarantee, supported by a claimed 100% FDA submission accuracy rate versus an industry average below 85% and a 0% rework rate versus the 15% industry average in additional fees for rework.

The firm's core technology is a clinical data management and analysis stack built on SAS, Python, R, and R Shiny, anchored by DataVIEWS, a proprietary five-module visualization platform purpose-built on R Shiny and CDISC standards. DataVIEWS provides near-real-time dashboards, enrollment and safety monitoring, site performance tracking, submission-ready TLF exports, patient profiles, and end-to-end traceability, running on validated cloud infrastructure meeting 21 CFR Part 11 and ICH E6(R2) requirements. TradeCraft maintains CDISC Gold Member status and employs a fully on-shore U.S. team with SAS programming staff averaging over 15 years of regulatory experience, exceeding the industry norm of 7-8 years.

TradeCraft makes money primarily through professional services (project-based programming and biostatistics engagements), managed services via the FSP model, and increasingly through licensing of its DataVIEWS platform. Pricing is quote-based with multi-year contracts; no public pricing tiers are disclosed. Distribution is direct enterprise sales augmented by LinkedIn (10,671+ followers), website content marketing, industry recognition (PharmaVOICE 100 for CEO Mike Willis), and referrals. In May 2026, TradeCraft entered a partnership with DeepkinetiX to deliver an integrated System of Record for PK Execution targeting Phase I sponsors, marking its most significant ecosystem expansion to date. Named customers include Advaxis (long-term multi-program relationship) and a small late-stage biotech of approximately 90 employees running a Phase III MAA submission.

Name

TradeCraft Clinical Research

Legal name

TradeCraft Clinical Research

Website

https://tradecraftclinical.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

TradeCraft Clinical Research is a U.S.-based sponsor-specialization CRO providing CDISC-compliant statistical programming, biostatistics, and its proprietary DataVIEWS visualization platform to biotech and pharmaceutical sponsors.

Ownership category

akta.pro rank

Product category

Clinical Research Services (CRO)

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

akta.pro secondary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Statistical programming services
• Biostatistics consulting
• Clinical data management
• CDISC-compliant submissions
• Clinical research services

Headquarters

HQ city

Wayne

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Statistical Programming Services: Full-service statistical programming including creating tables, figures, and listings (TLFs), SAS programming, SDTM/ADaM dataset implementation, macro development, and regulatory submission support for clinical trial data.
2. Biostatistics Services: Biostatistical consulting spanning study design, protocol development, statistical analysis plans, CDISC-compliant analysis datasets, data monitoring reports, clinical study reports, ISS/ISE planning, and regulatory submission support.
3. DataVIEWS Platform Subscription: Proprietary clinical data visualization platform offering near-real-time dashboards, enrollment tracking, safety monitoring, and submission-ready exports. Offered as a licensed/subscription offering to sponsors for trial oversight.
4. Functional Service Provider (FSP): Dedicated biostatistics and programming staffing model where TradeCraft provides expert resources integrated into the sponsor's team for ongoing trial support.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

TradeCraft Clinical Research is a sponsor-specialization contract research organization (CRO) that provides statistical programming, biostatistics consulting, and proactive project management to life sciences sponsors. The firm augments sponsor teams rather than replacing them, delivering CDISC-compliant SDTM/ADaM datasets, TLFs, SAS programming, statistical analysis plans, and regulatory submission support, with a regulatory submission acceptance guarantee backed by 100% FDA submission accuracy.

Product overview

TradeCraft Clinical Research offers a unified portfolio of sponsor-specialization CRO services centered on its proprietary DataVIEWS platform, complemented by Statistical Programming Services and Biostatistics Services. DataVIEWS is a five-module R Shiny-based visualization platform providing real-time data visibility, submission-ready TLF exports, and patient profiles. The core services encompass SDTM/ADaM implementation, SAS programming, statistical analysis plan development, and regulatory submission support, with additional offerings including gap analysis, CRO management, and functional service provider arrangements.

Differentiator

Problem solved

Functional benefit

Brands

• DataVIEWS: TradeCraft's proprietary data visualization platform built on R Shiny for clinical trial data analysis. The five-module system is fully customizable and designed for CDISC standards (SDTM and ADaM), producing outputs that support regulatory submissions. Features include near-real-time dashboards, submission-ready exports, site-level visibility, end-to-end traceability, and patient profiles.

Products and services

• DataVIEWS Proprietary five-module R Shiny-based clinical trial data visualization platform providing sponsors with near-real-time dashboards, enrollment tracking, safety signal monitoring, submission-ready TLF exports, site performance visibility, patient profiles, and end-to-end traceability from raw EDC data to CSR tables. Built on validated cloud infrastructure meeting 21 CFR Part 11 and ICH E6(R2) requirements.
• Statistical Programming Services Expert statistical programming consulting including SAS-based table, figure, and listing (TFL) creation, SDTM/ADaM dataset implementation, code validation, macro development, and regulatory submission support for clinical trial data, targeted at biotech and pharmaceutical sponsors.
• Biostatistics Services Comprehensive biostatistical consulting including study design, protocol development, statistical analysis plan authoring, CDISC-compliant analysis datasets, data monitoring committee reports, clinical study reports, ISS/ISE planning, and FDA/regulatory submission support for life sciences organizations.
• Functional Service Provider (FSP) Dedicated biostatistics and programming staffing model providing expert resources integrated into a sponsor's team for ongoing trial support, offering flexible resource allocation during peak trial phases or capacity constraints.

Quantifiable outcome

• 100% FDA submission accuracy vs. industry average below 85%
• +3 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• DeepkinetiXcoreTechnology or Integration · 15 May 2026TradeCraft and DeepkinetiX partnered to deliver the industry's first System of Record for PK Execution. The joint offering pairs DeepkinetiX's KinetixFlow™ deterministic pharmacokinetic execution platform with TradeCraft's regulatory agency data compliance guarantee and biometrics expertise. The partnership enables Phase I sponsors to run PK trials with audit-ready rigor from raw data to regulatory artifact, combining deterministic PK/NCA benchmarking with CDISC-compliant SDTM/ADaM datasets and TLFs, and full end-to-end traceability. TradeCraft's 100% submission acceptance rate combined with DeepkinetiX's PK execution infrastructure eliminates fragmented data handoffs that represent regulatory risk in complex molecule and oncology programs.

Scale indicators7 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• Medpace: Medpace is a mid-to-large full-service CRO with strong in-house biostatistics and programming capabilities serving biotech and pharma sponsors; it competes with TradeCraft for biometrics-led sponsor mandates while operating a much broader CRO service portfolio.
• Premier Research: Premier Research is a clinical development CRO serving biotech and specialty pharma with biostatistics, programming, and regulatory services; it competes with TradeCraft for sponsor biometrics and submission-support work within a broader service offering.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a global mid-size CRO offering full-service clinical development including biostatistics and programming; it overlaps with TradeCraft's biometrics service lines as part of a broader Phase I-IV CRO portfolio.
• Parexel International: Parexel is a large global full-service CRO with biostatistics and regulatory submission capabilities at enterprise scale; while its biometrics practice competes with TradeCraft, Parexel's broader portfolio spans Phase I-IV clinical operations, real-world evidence, and consulting.

Direct peers

• Veristat: Veristat is a mid-sized sponsor-specialization biometrics CRO providing biostatistics, statistical programming, data management, and regulatory submission support, with a comparable focus on helping sponsors avoid regulatory rejection.
• Statistics & Data Corporation (SDC): SDC is a biometrics-focused CRO offering biostatistics, SAS programming, CDISC-compliant data management, and FSP staffing to pharma and biotech sponsors, directly competing with TradeCraft in the same statistical programming niche.
• Cytel: Cytel is a sponsor-specialization biostatistics and statistical programming CRO offering CDISC-compliant SDTM/ADaM, TLF production, and biostatistics consulting to life sciences sponsors. It is the closest direct competitor to TradeCraft's biometrics/biostatistics niche.
• Berry Consultants: Berry Consultants is a specialized statistical consulting firm focused on biostatistics for clinical trials, including adaptive design and Bayesian methods, serving a similar biotech and pharma sponsor base as TradeCraft.

Emerging players

• Clinipace Worldwide: Clinipace is a mid-sized CRO focused on small-to-mid biotech sponsors, offering biometrics, programming, and full-service clinical development that overlaps with TradeCraft's specialty sponsor-support positioning.
• CROS NT: CROS NT is an emerging CRO focused on clinical data management, biostatistics, and statistical programming for European and global sponsors, with overlapping CDISC-compliant biometric services comparable to TradeCraft.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/tradecraft-clinical-research
• Xx.com/tradecraftcr
• Facebookfacebook.com/tradecraftclinical

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TradeCraft Clinical Research