Medelis

What Medelis does

Medelis is a specialty oncology contract research organization (CRO) providing full-service drug development support from preclinical through Phase III, with additional therapeutic area exposure in dental, nephrology, medical device/diagnostics, and neurology/CNS. Founded in 2003 and operating from the Phoenix/Scottsdale area with a wholly-owned European subsidiary (Medelis Europe, London), the company has completed 150+ oncology projects across 20+ indications spanning the US, Europe, and Asia. Its core technical differentiators are two proprietary methodologies developed with its Medical Advisory Board: the "Complete Phase Ib" multi-arm parallel trial design (intended to accelerate accrual versus traditional sequential Phase Ib approaches) and the "Context of Vulnerability" drug development paradigm that links genetic tumor profiles to targeted therapy rationale. Supporting capabilities include immunotherapy expertise dating to 2008 (CAR T, checkpoint inhibitors, bispecific antibodies), rescue study interventions, US market access consulting for non-US sponsors, and EDC-driven biometrics via partner Veristat.

The business model is professional-services CRO revenue earned through per-study contracts with biotech and pharmaceutical sponsors. Pricing is structured around unit-based costing with monthly billing and a no-change-orders policy providing cost certainty to clients. Go-to-market is direct enterprise field sales, heavily leveraged through Medical Advisory Board relationships, conference presence (ASCO, BIO Europe), and thought-leadership content (Peer Perspectives in Oncology abstracts, blog). Customer segments are primarily biotech and pharma sponsors developing oncology drugs — including venture-funded startups, established companies entering oncology, and European/Asian sponsors entering the US market. The company has demonstrated repeat engagement with named enterprise accounts including a Top 5 pharmaceutical company and US biotech sponsors whose programs received FDA breakthrough therapy designation.

Medelis is privately held with no parent company, no disclosed outside private equity or venture capital ownership, and founder/management ownership under Chairman and CEO Bob Bosserman, CEO Dan Weng, and founder/Medical Advisory Board Chairman Dr. Daniel Von Hoff. Operational leadership includes VP of Clinical Operations Brad Phillips, VP of Preclinical Studies Mike McGarry, and Managing Director of Medelis Europe Dr. Deirdre Tessman. The company has not raised external funding rounds and revenue is not publicly disclosed. Headcount of 51–100 employees places it in the small-to-mid CRO tier, with strategic positioning as a specialty alternative to large full-service incumbents for sponsors prioritizing oncology depth, senior operational talent, and partnership-style engagement over scale.

Name

Medelis

Legal name

Medelis

Website

https://medelis.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Ownership category

akta.pro rank

Product category

Oncology Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

akta.pro secondary industries

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

Keywords

• Oncology clinical research
• Contract research organization
• Drug development services
• Immuno-oncology trials
• Clinical trial management

Headquarters

HQ city

Nashville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Oncology CRO Services: Full-service contract research organization providing oncology clinical trial services from phase I through phase III. Revenue generated through professional services contracts including study design, study launch, study management, medical writing, biostatistics/data management, study rescue, drug development consulting, and regulatory access services.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Medelis is a specialty oncology Contract Research Organization (CRO) providing full-service drug development support from preclinical through phase III clinical trials. The company delivers clinical study design, site selection and study launch, study management and monitoring, medical writing, biometrics and data management, study rescue services, drug development consulting, and U.S. market access consulting for biotech and pharmaceutical sponsors developing oncology and immuno-oncology drugs.

Product overview

Medelis is a specialty oncology CRO providing full-service drug development from preclinical through phase III. The company's core offering is its Oncology CRO Services platform, which integrates multiple service modules including Study Design, Study Launch, Study Management, Medical Writing, Biometrics/Data Management (B/DM), Study Rescue, Drug Development Consulting, Access to the U.S. Market, and Bioequivalence Design. Supporting capabilities include dedicated Immunotherapy Expertise (with CAR T-cell, checkpoint inhibitor, and bispecific antibody experience since 2008), Operational Expertise, Investigator Relationships, Site Training, and Preclinical Services. The company also provides knowledge resources through its Peer Perspectives in Oncology abstract series. Services span oncology, dental, nephrology, medical device/diagnostics, and neurology/CNS therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Oncology CRO Services Full-service contract research organization providing comprehensive oncology drug development services from preclinical through phase III, including clinical strategy, protocol design, regulatory support, and study execution for immunotherapy and other oncology treatments. Targeted at biotech and pharmaceutical companies developing oncology drugs.
• Study Design Clinical study design services including protocol development, endpoint selection, and regulatory strategy for oncology trials. Offered to biotech and pharma sponsors developing oncology drugs.
• Study Launch Site selection, investigator relationships management, and study initiation services to get oncology studies up and running quickly. Targets biotech and pharma sponsors needing rapid study startup.
• Study Management Ongoing trial management including monitoring, data collection, and project coordination with flexible resourcing and unit-based costing. Used by biotech and pharma sponsors managing oncology trials.
• Medical Writing Clinical and regulatory medical writing services for study documentation, reports, and submissions. Serves oncology drug development sponsors.
• Biometrics/Data Management (B/DM) Comprehensive biometrics services including data management, statistical analysis, and clinical data handling with Electronic Data Capture (EDC) capabilities delivered in partnership with Veristat. For oncology trial sponsors.
• Study Rescue Intervention services to salvage struggling oncology trials that are behind schedule, over budget, or facing quality or data issues. Used by sponsors with troubled oncology trials requiring expert rescue.
• Drug Development Consulting Strategic consulting services to supplement sponsor teams with oncology expertise and regulatory knowledge. Serves biotech and pharma sponsors developing oncology drugs.
• Access to the U.S. Market Consulting and regulatory pathway services to help non-U.S.-based companies enter the U.S. drug development and clinical trial market. Targets European and Asian biotech/pharma sponsors.
• Bioequivalence Design Study design services for bioequivalence assessments in support of generic drug development. Used by sponsors requiring bioequivalence study design support.
• Preclinical Services Preclinical study design, management, and execution including feasibility studies, proof of principle experiments, model development, and efficacy assessments using specialized oncology research models. For biotech and pharma clients developing oncology drugs.

Quantifiable outcome

• Completed 150+ oncology projects
• +3 more outcomes

Named customers4 records

Segments2 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature2 records

Partnerships

Four partnerships are on record, tiered core and minor.

• TGen (Translational Genomics Research Institute)coreStrategic or Co-development PartnerDr. Daniel Von Hoff serves as Senior Investigator and Head of Translational Research at TGen's Translational Drug Development Division and Head of Pancreatic Cancer Research Program. Deep collaborative relationship in oncology research and drug development.
• U.S. OncologycoreStrategic or Co-development PartnerDr. Von Hoff serves as Chief Scientific Officer for U.S. Oncology. Strategic partnership for oncology clinical research and drug development, including the complete phase Ib trial approach conducted through U.S. Oncology Research.
• Premiere OncologyminorStrategic or Co-development PartnerPrivate oncology site in California and Arizona led by Dr. Lee Rosen and Dr. Michael Gordon. Dr. Gordon is one of the medical founders of Medelis, and Medelis often recommends Premiere Oncology to sponsors.
• Scottsdale HealthCare's Virginia G Piper Cancer Center / TGen Clinical Research CentersminorStrategic or Co-development PartnerCollaborative research relationship with experienced staff from TGen Clinical Research Centers and Scottsdale Clinical Research Institute working together on oncology studies.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Medpace: Mid-to-large full-service CRO with a strong oncology franchise, deep therapeutic expertise, and a sponsor-focused operating model closely analogous to Medelis — both compete for biotech and pharma oncology programs with medically-led teams rather than generic staffing.
• Worldwide Clinical Trials: Mid-sized specialty CRO with significant oncology and rare disease focus, often positioned as an agile alternative to large CROs — directly comparable to Medelis on size, therapeutic focus, and customer segment (mid-cap biotech and pharma).
• Translational Drug Development (TD2): Oncology-focused CRO based at TGen (Translational Genomics Research Institute) with deep ties to Dr. Daniel Von Hoff; offers preclinical-to-Phase II oncology drug development services and competes head-to-head with Medelis for immuno-oncology sponsors.
• Pharm-Olam: Specialty mid-sized CRO with strong oncology and infectious disease focus, targeting biotech and mid-pharma sponsors with full-service Phase I-IV capabilities — comparable in size, therapeutic emphasis, and customer profile to Medelis.
• Ergomed: Specialty CRO with notable oncology and rare disease exposure, providing full-service clinical research plus pharmacovigilance — comparable to Medelis as a focused, sponsor-friendly alternative to mega-CROs in oncology drug development.
• Premier Research: Specialty CRO with deep oncology, rare disease, and pediatric focus serving small-to-mid biotech — directly comparable in therapeutic specialization, sponsor profile, and competitive positioning to Medelis.

Broad incumbents

• IQVIA: Largest global CRO with extensive oncology capabilities and proprietary technology platforms (e.g., EDC, real-world data); competes with Medelis for biotech oncology programs that require global scale and integrated data, though lacks Medelis' specialty boutique positioning.
• ICON plc: Major global CRO (post-PRA Health Sciences merger) with significant oncology therapeutic expertise and broad service portfolio — competes with Medelis on larger oncology programs while Medelis targets the nimble specialty niche.
• Labcorp Drug Development (formerly Covance): Large CRO with integrated central laboratory and clinical development services including oncology; competes with Medelis in larger oncology trials and offers the lab/biomarker infrastructure Medelis accesses via Veristat partnerships.
• Charles River Laboratories: Preclinical and clinical CRO with oncology discovery and early development services — overlaps with Medelis' preclinical offering (Mike McGarry's VP of Preclinical Studies work) and competes for early-stage oncology biotech sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/oncologycro
• LinkedInlinkedin.com/company/medelis-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 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 Medelis