What Trialwise does

Trialwise, Inc. is a privately held, woman-owned boutique Contract Research Organization incorporated in California and headquartered in Foster City, CA, founded by Beth Brinsdon in 1999 and rebranded under its current name in 2015. The company specializes exclusively in Phase I and II clinical studies, operating with 11-50 employees and a deliberately limited client roster to deliver personalized, high-touch service. Its service portfolio comprises six interconnected modules: Clinical Operations (study management, site/investigator identification, IRB submissions, IP management, TMF), Data Management (CRF/database design, edit checks, data cleaning, coding), Biostatistics (CDISC-compliant programming, SAP design, TLFs, efficacy endpoint analysis with therapeutic expertise in Alzheimer's, Cushing's, Parkinson's, ALS, and clinical pharmacology), Medical Writing (IND support, IBs, protocols, CSRs, safety narratives, trial registration), Staffing Support (temporary and long-term placement across functional areas), and Augmented Services (niche consulting, safety management, QA, medical monitoring, pharmacovigilance).

The company's underlying technology stack centers on clinical trial data management and operations tooling, including eTMF (electronic Trial Master File) and eSource implementations, executed as a cross-functional team without internal silos. A proprietary Risk Adaptive Monitoring Framework, adapted from TransCelerate Biopharma's Risk Based Monitoring initiative and developed since May 2022, was deployed in June 2024 in a multicenter Phase 1 HIV trial. Trialwise operates a referral-driven, sales-led go-to-market, primarily targeting startup and small-to-midsize biotech companies with secondary exposure to Fortune 500 pharmaceutical programs and government/nonprofit research institutions (e.g., SRI International under NIH/NIAID funding). Revenue is generated through professional services contract research agreements; no public pricing exists. Customer acquisition is largely referral-based and relationship-driven rather than marketing-led, with industry-conference presence and earned media (e.g., National Geographic, BBC, NPR coverage of the HOPO 14-1 program) supplementing brand visibility.

Name

Trialwise

Legal name

Trialwise, Inc.

Website

https://trialwise.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

Trialwise is a privately held, woman-owned boutique CRO specializing exclusively in Phase I and II clinical studies for startup and small-to-midsize biotech companies, with additional government and Fortune 500 work. It delivers integrated clinical operations, data management, biostatistics, and medical writing services.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

Keywords

• Clinical trial services
• Contract research organization
• Phase I clinical studies
• Biostatistics services
• Medical writing services

Headquarters

HQ city

Houston

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Trialwise generates revenue by providing comprehensive clinical trial services including clinical operations, data management, biostatistics, medical writing, and staffing support for Phase I and II clinical studies. Services are provided to sponsors including biotech companies, pharmaceutical companies, and government/research institutions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Trialwise is a boutique Contract Research Organization (CRO) that delivers integrated Phase I and II clinical study services, including clinical operations, data management, biostatistics, and medical writing, supplemented by staffing support and augmented services such as safety management, quality assurance, medical monitoring, and pharmacovigilance. The firm operates as a cross-functional team embedded within sponsor organizations, serving startup and small-to-midsize biotech companies as well as government and nonprofit research institutions.

Product overview

Trialwise is a boutique Contract Research Organization (CRO) offering an integrated portfolio of six interconnected service modules for Phase I and II clinical studies. The core service suite comprises Clinical Operations (study management, site management, monitoring), Data Management (database design, data cleaning, coding), Biostatistics (statistical analysis, CDISC-compliant programming), and Medical Writing (protocols, CSRs, regulatory documents). Two additional modules—Staffing Support (temporary and long-term placement) and Augmented Services (consulting, safety management, QA, pharmacovigilance)—provide flexibility to scale and customize engagement based on client needs. The company positions itself as a high-touch, collaborative partner for startup and mid-size biotech companies, functioning as an integrated extension of sponsor organizations.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Operations Comprehensive Phase I/II study management encompassing site/investigator identification and qualification, central IRB submissions including risk-based approaches, investigational product management, Trial Master File management, study-specific plan development, ICF development, source document development, vendor management, and study quality risk identification and management. Provided to biotech and pharmaceutical sponsors for early-phase clinical trials.
• Data Management
• Biostatistics
• Medical Writing
• Staffing Support
• Augmented Services

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Three partnerships are on record, tiered core and minor.

• Skye BiosciencecoreStrategic or Co-development Partner · 6 November 2023Trialwise served as biometrics partner for Phase 1 study of Skye Bioscience's SBI-100 Ophthalmic Emulsion, a first-in-class CB1 receptor agonist for glaucoma treatment. Trialwise created the statistical analysis plan and provided data management, biostatistics, and medical writing services since November 2021. The study demonstrated positive tolerability results in healthy volunteers.
• SRI InternationalcoreStrategic or Co-development Partner · 16 August 2023Trialwise serves as CRO partner for SRI International's Phase 1 first-in-human clinical trial of HOPO 14-1, an oral treatment for internal radioactive contamination. Trialwise provides clinical operations, data management, biostatistics, and medical writing services. The study is funded by NIH/NIAID (Contract No. 75N93020D00011) and has received media coverage including National Geographic, BBC, and NPR.
• TransCelerate BiopharmaminorOthersTrialwise's proprietary Risk Adaptive Monitoring Framework is adapted from TransCelerate Biopharma's Risk Based Monitoring initiative established in 2012. Trialwise adapted this approach for Phase 1 trials with smaller data sets, which proved challenging for traditional RBM implementation.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Celerion: Celerion is a contract research organization focused on early-phase clinical pharmacology (Phase 1 SAD/MAD, bioequivalence, DDI) and clinical bioanalytical services. Like Trialwise, it specializes in Phase 1 trials serving biotech and pharma sponsors with biometrics and operations under one roof, making it the closest direct comparison.
• Altasciences: Altasciences is a mid-size CRO offering early-phase clinical development including first-in-human and biopharmaceutics studies. Its early-phase focus, integrated clinical/biopharma/biometrics offering, and mid-tier positioning make it a directly comparable peer for Trialwise's boutique Phase I/II niche.
• Bioanalytical Systems Inc (BASi): BASi is a CRO providing early-stage drug development, bioanalytical services, and nonclinical/clinical research. It is comparable to Trialwise as a smaller specialized CRO with discovery through Phase I capabilities and a focus on biotech customers.
• Clinipace Worldwide (now Medios Technologies / dMed): Clinipace is a mid-size CRO focused on small-to-mid biotech and specialty pharma trials, with therapeutic-area expertise in oncology, rare disease, and CNS. Its mid-tier boutique character is comparable to Trialwise's positioning serving similar sponsor segments.

Broad incumbents

• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-size global CRO with Phase I clinical pharmacology and biometrics capabilities. It sits between boutique CROs like Trialwise and tier-1 incumbents, and competes for the same early-phase biotech business.
• Medpace: Medpace is a full-service mid-size CRO with strong early-phase capabilities and an integrated biometrics/medical writing value proposition. While significantly larger and broader than Trialwise, it competes for the same biotech-sponsored Phase I/II work with a similar cross-functional model.
• PAREXEL International: PAREXEL is a large global full-service CRO with early-phase, biometrics, and medical writing services. Its Phase I unit competes with Trialwise for biotech and government Phase I/II work, despite PAREXEL's much broader portfolio.
• ICON plc: ICON is a global full-service CRO offering early-phase through post-approval clinical services. Trialwise competes for Phase I/II biometrics and operations engagements against ICON's early development unit, and ICON's 2021 PRA acquisition materially expanded its Phase 1 footprint.
• Charles River Laboratories: Charles River provides a comprehensive CRO/CDMO offering including early-phase clinical services (via its Clinical & Discovery Services). Although larger and broader, it overlaps with Trialwise in early-phase clinical operations and biometrics for biotech sponsors.

Emerging players

• Emmes (now part of Optum): Emmes is a mid-size CRO with strong government and NIH-funded trial experience (similar to Trialwise's SRI/NIAID work). Its biotech and government research focus and biometrics capabilities make it a relevant comparable peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Trialwise