What Highline Sciences does

Highline Sciences (legal entity Highline Consulting LLC) is a specialized, oncology-focused contract research organization and consultancy founded in 2014 and headquartered in San Francisco. The firm provides full-service and functional clinical trial support to small and mid-market biotechnology companies, spanning Phase I through Phase III studies, with particular depth in orphan designation, first-in-human, biomarker/companion diagnostic, dose escalation/expansion, and modern adaptive trial designs (basket, umbrella). Service modules cover project management, feasibility and site identification, study startup, clinical monitoring and site management, regulatory affairs, data management, biostatistics, medical affairs, safety and pharmacovigilance, medical writing, quality assurance, investigator payments, clinical development consulting, and staff augmentation. Revenue is generated through professional-services arrangements — bespoke, partnership-oriented engagements priced per project rather than on standardized SaaS terms — with no publicly disclosed pricing.

The operational technology stack is built on third-party best-in-class platforms rather than proprietary software: Veeva Vault CTMS/eTMF for study management, Oracle Argus Safety for adverse event management (configured in-house for sponsor-specific deployments), and Medidata RAVE and Medrio as preferred EDC systems. Distribution is direct B2B field sales to biotech sponsors, with services delivered globally despite a single San Francisco headquarters. The company was acquired by Tempus and has been rebranded as Tempus Compass, integrating oncology CRO delivery into Tempus's broader portfolio of sequencing, data collaborations, and AI-enabled clinical trial solutions.

Name

Highline Sciences

Legal name

Highline Consulting LLC

Website

https://highlinesciences.com

Company type

Private

Founded year

2014

Operating status

Acquired

Headcount range

11–50 employees

Short description

Highline Sciences is an oncology-focused contract research organization serving small to mid-market biotech companies with full-service and functional clinical trial support from Phase I through Phase III. The firm was acquired by Tempus and rebranded as Tempus Compass.

Ownership category

akta.pro rank

Product category

Clinical Research Organization (CRO) Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Site Start-Up & Activation (Regulatory/Ethics/Contracts) (HLAGACAC), Life Sciences & Biotech (R&D/Clinical) Staffing (BPACADAL), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

Keywords

• Oncology clinical trials
• Contract research organization
• Clinical trial management
• Drug development consulting
• Biotech clinical services

Headquarters

HQ city

San Francisco

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. Full-Service Clinical Trial Support: Comprehensive CRO services including project management, clinical monitoring, data management, biostatistics, regulatory affairs, and medical writing for Phase I-III oncology trials
2. Functional Service Support: Individual resource augmentation and specialized services such as site management, feasibility, study startup, investigator payments, and quality assurance
3. Clinical Development Consulting: Consulting services for early-stage companies preparing for clinical development and established companies needing program support
4. Staff Augmentation: Providing qualified clinical staff at all levels to augment client workforces, including evaluation of existing staff and identification of specialists

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Highline Sciences is a specialized, full-service Contract Research Organization (CRO) and consultancy that provides oncology-focused clinical trial support for small to mid-market biotech companies. Services span Phase I through Phase III trials and include project management, clinical monitoring, data management, biostatistics, regulatory affairs, safety/pharmacovigilance, medical writing, and quality assurance, delivered as full-service, functional, or staff augmentation engagements.

Product overview

Highline Sciences is a specialized, full-service CRO and consultancy founded from within an oncology biotech. It offers a comprehensive suite of clinical trial services structured as integrated modules including project management, feasibility and site identification, study startup, clinical monitoring and site management, regulatory services, data management, biostatistics, medical affairs, safety and pharmacovigilance, medical writing, and quality assurance. The company also provides staff augmentation, clinical development consulting, and specialized oncology trial design services (Phases I-III, orphan designation, first-in-human, modern basket/umbrella designs, biomarker and companion diagnostics, dose escalation). Services are delivered using operational technology platforms including Veeva Vault CTMS/eTMF, Oracle Argus Safety, and EDC systems (Medidata RAVE, Medrio). Highline Sciences was acquired by Tempus and has been rebranded as Tempus Compass, integrating into Tempus's broader data and AI-powered healthcare solutions.

Differentiator

Problem solved

Functional benefit

Brands

• Tempus Compass: The rebranded clinical trial solutions division of Highline Sciences under Tempus, offering clinical trial services to biopharma companies.

Products and services

• Clinical Trial Services Full-service and functional clinical trial support for small to mid-market biotech companies, spanning Phase I through Phase III, with deep expertise in oncology. Delivered as a coordinated engagement with A-team support globally.
• Clinical Development Consulting Consulting services for early-stage biotech companies preparing for clinical development and for established companies needing extra program support, including trial planning, forecasting, and execution.
• Staff Augmentation Workforce augmentation service that evaluates existing client staff, identifies required additional skills, and supplies qualified clinical professionals and industry specialists at all levels to complement sponsor workforces.

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature3 records

Partnerships

Four partnerships are on record, tiered core and flagship.

• VeevacoreTechnology or IntegrationHighline Sciences utilizes Veeva Vault CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) systems for integrated study management. The integration enables streamlined processes from site activation through close-out within a single system, increasing visibility, quality, and efficiency throughout the study lifecycle.
• OraclecoreTechnology or IntegrationHighline Sciences uses Oracle Argus Safety, the industry-leading adverse event management system. The Argus Safety database can be configured for single or multiple studies and compounds within a sponsor-specific Argus Enterprise, with all configuration completed in-house for flexibility and responsiveness.
• MedidatacoreTechnology or IntegrationMedidata RAVE is a preferred EDC system due to its flexibility in design and ease of use for site staff. Data is readily visible and available for reporting, improving ability to analyze and make key decisions throughout clinical trials.
• TempusflagshipStrategic or Co-development PartnerHighline Sciences has been acquired by Tempus and operates under the Tempus Compass brand. Tempus brings the power of data and AI to healthcare and offers multiple solutions for biopharma ranging from sequencing and data collaborations to clinical trial solutions. This acquisition integrates Highline's CRO services with Tempus's broader data and AI capabilities.

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Tempus AI: Parent company of Highline Sciences (now Tempus Compass). Tempus is a data and AI healthcare company that acquired Highline to offer clinical trial solutions alongside its sequencing and data collaboration services. Relevant as the integrated platform that Highline now operates within.
• IQVIA: Global tier-1 CRO offering full-service clinical trial support across all therapeutic areas including oncology. Competitor to Highline for mid-market and large biopharma oncology trials, with broader scale, site networks, and technology platform.
• ICON plc: Global CRO providing full-service and functional clinical trial services across therapeutic areas including oncology. Competes with Highline/Tempus Compass for biotech-sponsored oncology trials, particularly at the larger end of the market.
• Parexel International: Large global CRO offering comprehensive oncology clinical development services. A direct competitor in the mid-market oncology CRO space where Highline/Tempus Compass operates, with stronger late-phase capabilities.
• Fortrea (formerly LabCorp Drug Development): Global full-service CRO spun out from LabCorp, offering clinical development services across therapeutic areas including oncology. Competes broadly with Highline for oncology trial work at scale.
• Syneos Health (now part of Elliott/Private): Global CRO with full-service and functional service offerings across therapeutic areas including oncology. Competes with Highline/Tempus Compass for mid-market and enterprise biotech sponsors.

Direct peers

• Medpace Holdings: Mid-sized full-service CRO with particular strength in oncology, cardiovascular, and metabolic therapeutic areas. Medpace serves small and mid-market biotech sponsors with a full-service model, directly competing with Highline/Tempus Compass in oncology Phase I-III trials.
• Worldwide Clinical Trials: Mid-sized CRO with strong oncology and early-phase specialization serving small and mid-market biopharma. Comparable to Highline in its boutique positioning and therapeutic-area focus, making it a direct peer for oncology biotech clients.
• Novella Clinical (IQVIA Oncology): Oncology-focused CRO unit within IQVIA historically serving small/mid-market oncology biotechs. Direct historical competitor to Highline Sciences in specialized oncology trial services for emerging biotech sponsors.

Emerging players

• Precision Medicine Group: Specialized clinical development services provider with oncology focus and complementary biomarker/precision medicine capabilities. Overlaps with Highline's oncology specialty positioning and biomarker-driven trial design expertise.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/highlinescience
• LinkedInlinkedin.com/company/highlinesciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Highline Sciences