ProtoMed
ProtoMed Therapeutics is a privately held New York-based clinical research organization that provides biostatistics, clinical data management, clinical programming, clinical trials, pharmacovigilance, medical writing, and medical device regulatory services to pharmaceutical, biotechnology, and medical device manufacturers.
- Company typePrivate
- Founded1998
- HeadquartersNew York, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What ProtoMed does
ProtoMed Therapeutics, Inc. is a privately held clinical research organization headquartered at 82 Nassau Street, New York, NY, operating under dual entity names (ProtoMed Therapeutics, Inc. and ProtoMed BioSciences, Inc.) with a founding history extending to 1998. The company delivers a comprehensive, horizontal suite of clinical research services to pharmaceutical companies, biotechnology companies, and medical device manufacturers. Its core offerings span biostatistics, clinical data management, clinical programming, clinical trials (Phase I-IV), clinical pharmacology, pharmacovigilance and drug safety, medical writing, clinical study reports, manuscript preparation, and medical device regulatory services including FDA 510(k) submissions, CE marking, and international registration in the Americas, Asia, Europe, and the Middle East.
The technology stack rests on a CDISC-compliant foundation with expertise in SDTM, CDASH, and ADaM formats, supported by a proprietary library of more than 60 validated SAS macros that accelerate statistical analysis. The company runs pharmacovigilance operations using industry-standard platforms (ARISg, ARGUS, Oracle AERS) and employs signal detection methodologies including MGPS, EBGM, PRR, ROR, and IC for drug safety surveillance. The firm's clinical pharmacology capability is anchored by state-of-the-art Clinical Pharmacology Centers supporting in-house Phase I studies with volunteer accommodation and constant medical supervision. Regulatory documentation capabilities extend to eCTD-format electronic submissions for INDs, NDAs, and international dossiers.
The business model is fee-for-service professional services sold through direct B2B engagement with enterprise clients. Pricing is project-based and quote-driven, customized to scope and complexity, and typically structured under multi-year contracts. The company markets primarily through its corporate website showcasing depth of service offerings and regulatory compliance expertise, with SEO supporting organic discovery by life sciences professionals. Headcount is in the 101-250 range, anchored by a team of 15+ biostatisticians with specialized degrees and SAS Institute training, supported by a broader multidisciplinary team. The public-facing homepage positions the company as a "next-generation biotechnology company" engineering therapeutics; this positioning contrasts with the operational reality of CRO-style service delivery and represents an unresolved strategic positioning tension within the company.
ProtoMed firmographics
Firmographics- Name
- ProtoMed
- Legal name
- ProtoMed Therapeutics, Inc.
- Website
- https://protomed.org
- Company type
- Private
- Founded year
- 1998
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- ProtoMed Therapeutics is a privately held New York-based clinical research organization that provides biostatistics, clinical data management, clinical programming, clinical trials, pharmacovigilance, medical writing, and medical device regulatory services to pharmaceutical, biotechnology, and medical device manufacturers.
- Ownership category
- akta.pro rank
ProtoMed industry classification
Industry- Product category
- Clinical Research Services (Contract Research Organization)
- NAICS
- Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)
- akta.pro secondary industries
- Nonclinical Study Management & Regulatory Writing (IND-enabling) (HLAGAFAN), Preclinical Development (Pharmacology, PK/PD, ADME, Toxicology) (HLAIALAC)
Keywords
Where ProtoMed is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
ProtoMed business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Clinical Research Services: Fee-for-service professional services model providing clinical trial development, statistical analysis, data management, and regulatory documentation to pharmaceutical and biotech companies. Revenue generated through project-based engagements spanning early discovery through pivotal trials.
- Pharmacovigilance Services: Ongoing drug safety surveillance services including aggregate reporting, signal detection, and comprehensive risk management plans throughout product lifecycle.
- Medical Writing Services: Regulatory and clinical documentation services including clinical study reports, protocols, investigator brochures, NDAs, and manuscripts for peer-reviewed journals.
- Medical Device Regulatory Services: Comprehensive regulatory support for medical device registration including FDA submissions, CE marking, and international registration across Americas, Asia, Europe, and Middle East.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Project-based professional services pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
ProtoMed product offering
Product offeringCore offering
ProtoMed provides full-service clinical research and regulatory support to pharmaceutical, biotechnology, and medical device sponsors. Its offerings span biostatistics, clinical data management, clinical programming, clinical trial execution, clinical pharmacology, pharmacovigilance and drug safety, medical writing (including clinical study reports and manuscripts), and medical device regulatory registration.
Product overview
ProtoMed is a next-generation biotechnology company offering a comprehensive suite of clinical research and medical writing services. The company provides an integrated platform of service offerings including Biostatistics Services, Clinical Data Management, Clinical Programming, Clinical Trials Services, Clinical Pharmacology, Pharmacovigilance & Drug Safety, Medical Writing, Clinical Study Reports, Manuscripts & Publications, and Medical Device Regulatory Services. These services are designed to support pharmaceutical and biotech companies throughout the drug development lifecycle from early discovery through pivotal trials, with expertise spanning Phase I through Phase IV clinical studies.
Differentiator
Problem solved
Functional benefit
Quantifiable outcome
- Library of over 60 validated SAS macros speeds up statistical analysis time and reduces costs
Companies that use ProtoMed
Customer profileSegments3 records
Ideal customer profiles2 records
ProtoMed technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
ProtoMed partnerships and signals
Strategic signalScale indicators1 record
Recent moves5 records
Expansion highlights4 records
ProtoMed competitors and assessment
Company assessmentDirect peers
- Syneos Health: Clinical and commercial services organization providing Phase I–IV clinical development, biostatistics, and pharmacovigilance — a same-shape competitor to ProtoMed.
- Parexel International: Full-service CRO with biostatistics, clinical pharmacology, regulatory submission, and medical writing offerings that compete head-to-head with ProtoMed for sponsor RFPs.
- Medpace: Mid-sized full-service CRO running Phase I–III trials with deep biostatistics, medical writing, and regulatory capabilities — the closest operating analog to ProtoMed for sponsor procurement comparisons.
- ICON plc: Global CRO offering biostatistics, clinical research, pharmacovigilance, and medical device services across all phases — directly comparable across nearly every ProtoMed service line.
- Worldwide Clinical Trials: Mid-sized global CRO with strong early-phase and medical writing capabilities, frequently competing with ProtoMed on complex Phase I/II studies.
Broad incumbents
- IQVIA: Largest global CRO and life sciences services firm; competes broadly across biostatistics, clinical operations, pharmacovigilance, and regulatory submissions.
- Charles River Laboratories: Preclinical and clinical services provider with strong early-phase and biostatistics capabilities; competes with ProtoMed's clinical pharmacology and Phase I offerings.
- Labcorp Drug Development (Fortrea): Major incumbent CRO (now Fortrea) offering end-to-end Phase I–IV services and central laboratory testing; overlaps with ProtoMed across nearly all service lines.
Emerging players
- TFS HealthScience: Specialty CRO offering clinical, biostatistics, and medical writing services across multiple therapeutic areas — a close peer in size and service scope.
- Rho: Specialized CRO focused on biostatistics, data management, and regulatory services for small/mid sponsors — comparable in scale and service mix to ProtoMed.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
ProtoMed financial estimates
Financial estimateRevenue estimate
Valuation estimate
ProtoMed leadership team
Management profileNumber of profiles
ProtoMed funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ProtoMed 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 ProtoMed
What does ProtoMed do?
ProtoMed provides full-service clinical research and regulatory support to pharmaceutical, biotechnology, and medical device sponsors. Its offerings span biostatistics, clinical data management, clinical programming, clinical trial execution, clinical pharmacology, pharmacovigilance and drug safety, medical writing (including clinical study reports and manuscripts), and medical device regulatory registration.
Is ProtoMed a public or private company?
ProtoMed is a private company. It is classified as unknown and is currently operating.
When was ProtoMed founded?
ProtoMed was founded in 1998. It employs 101 to 250 people.
Where is ProtoMed based?
ProtoMed is headquartered in New York, United States, in the North America region.
How does ProtoMed make money?
Four revenue lines are on record. Clinical Research Services are the primary driver. The others are pharmacovigilance Services, medical Writing Services and medical Device Regulatory Services.
Who are ProtoMed's main competitors?
Direct peers on record are Syneos Health, Parexel International, Medpace, ICON plc and Worldwide Clinical Trials. Broad incumbents are IQVIA, Charles River Laboratories and Labcorp Drug Development (Fortrea). Emerging players are TFS HealthScience and Rho.
Does ProtoMed have an API?
No public API is recorded for ProtoMed.
What industry is ProtoMed in?
ProtoMed's product category is Clinical Research Services (Contract Research Organization). Its primary akta.pro industry code is HLAIALAE, Clinical Development (Phase I–III Trial Design & Execution), with a secondary code of HLAGAFAN, Nonclinical Study Management & Regulatory Writing (IND-enabling). Its NAICS code is 5417 and its SIC code is 8731.