Prometrika

What Prometrika does

Prometrika, LLC is a privately held, founder-owned full-service Clinical Research Organization (CRO) headquartered in Cambridge, Massachusetts, founded in 2003 by Dr. Miganush Stepanians. The firm provides integrated clinical development services to biotech, pharmaceutical, and medical device sponsors across the full drug development lifecycle, from pre-IND planning through Phase 4 and NDA/BLA/MAA regulatory submissions with the FDA and EMA. Its service modules include Strategic Consulting, Clinical Operations, Data Management, Biostatistics & Programming (with CDISC SDTM and ADaM expertise), Medical Writing, Pharmacovigilance, and Full-Service Clinical Trial Management, supported by adaptive design, decentralized clinical trial (DCT), and Independent Data Monitoring Committee capabilities.

The technology stack is built on industry-standard third-party platforms rather than proprietary infrastructure: Prometrika is a Certified Medidata Services Provider with expertise in Medidata Rave EDC (used since 2013) and was the first CRO accredited in the Medidata Patient Cloud platform, supplemented by CTMS, eTMF, eCOA, and IWRS/RTSM systems. The firm operates as a B2B professional services company selling customized, project-based engagements through a direct sales model anchored by a Director of Client Relations; pricing is not publicly disclosed. Customer segments span biopharma (primary), rare disease companies, oncology sponsors, and medical device manufacturers, with the firm's rare disease track record (85+ studies) and oncology experience serving as primary differentiators.

Prometrika is differentiated by a regulatory submission track record of more than 20 NDA/BLA/MAA dossiers, 40+ years of senior regulatory affairs experience, global delivery capability through strategic partnerships with local CROs in 80+ countries across 5 continents, AICROS consortium membership (joined 2018), CDISC Platinum status with an Advisory Council seat, WBENC women's business enterprise certification, and senior leadership drawn from IQVIA, PAREXEL, Quintiles, Wyeth, and Bayer. The firm has 101-250 employees, no disclosed external institutional investors, and pursues geographic and product-line expansion (notably DCT) through organic reinvestment rather than M&A or external funding.

Name

Prometrika

Legal name

PROMETRIKA, LLC

Website

https://prometrika.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

101–250 employees

Short description

Prometrika is a Cambridge, MA-based full-service CRO offering clinical operations, biostatistics, data management, medical writing, pharmacovigilance, and regulatory affairs to biotech, pharmaceutical, and medical device sponsors, with rare disease and oncology as primary therapeutic strengths and global delivery via 80+ country CRO partnerships.

Ownership category

akta.pro rank

Product category

Clinical Research Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

Keywords

• Clinical research organization
• Clinical trial management
• Biostatistics programming services
• Regulatory affairs consulting
• Pharmacovigilance services

Headquarters

HQ city

Cambridge

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, Infrastructure

Revenue model

1. Clinical Research Services: Full-service CRO providing comprehensive clinical research services to biopharmaceutical and medical device companies across all phases of drug development from pre-IND through Phase 4 and regulatory submissions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Core offering

PROMETRIKA is a full-service Clinical Research Organization (CRO) that designs, manages, and executes clinical trials for biotech, pharmaceutical, and medical device companies across all phases of drug development (pre-IND through Phase 4 and NDA/MAA regulatory submissions). The company delivers integrated functional services including strategic consulting, clinical operations, data management, biostatistics and CDISC SDTM/ADaM programming, medical writing, pharmacovigilance, and regulatory affairs, acting as a single outsourced partner from pre-clinical planning through commercialization support.

Product overview

PROMETRIKA is a full-service Clinical Research Organization (CRO) founded in 2003, offering integrated service modules across the drug development lifecycle. The company provides a unified platform of functional services including Strategic Consulting, Clinical Operations, Data Management, Biostatistics & Programming, Medical Writing, Pharmacovigilance, and Full-Service Clinical Trial Management. These services are designed to work collaboratively, with PROMETRIKA acting as a single partner from pre-clinical planning through regulatory submission, supporting drugs, biologics, and devices. The company also offers specialized capabilities in rare diseases and oncology, with global reach across 80+ countries through strategic partnerships.

Differentiator

Problem solved

Functional benefit

Products and services

• Strategic Consulting Advisory services encompassing clinical program planning, statistical consulting, regulatory affairs and operations, technology solutions, and infrastructure support to guide product development strategy for biotech and pharma sponsors.
• Full-Service Clinical Trial Management Comprehensive end-to-end management of clinical trials across all phases (pre-IND, IND, Phase 1-3, NDA, Phase 4), including protocol development, adaptive trial design, decentralized clinical trials, Independent Data Monitoring Committee (IDMC) services, and global trial execution for sponsors.
• Clinical Operations Site monitoring, patient recruitment, site management and engagement, and oversight of clinical vendor relationships to ensure trial execution meets quality and regulatory standards.
• Data Management Electronic data capture (EDC) system design, build, and management including database programming, data validation, and reconciliation with external sources such as laboratories and randomization tools, with Medidata Rave EDC expertise.
• Biostatistics and Programming Statistical design of clinical trials, analysis of Phase 1-4 studies, CDISC SDTM and ADaM programming, tables listings and figures (TLFs) generation, and statistical support for regulatory submissions.
• Medical Writing Clinical study reports, regulatory submission documents, protocol development, and integrated summaries of efficacy and safety for NDA/BLA/MAA dossiers.
• Pharmacovigilance Drug safety monitoring, adverse event reporting, risk management, individual case safety report (ICSR) processing, and safety database management throughout the product lifecycle.
• Regulatory Affairs Regulatory strategy development, IND/NDA/BLA/MAA preparation, health authority interactions, and submission support for FDA and EMA approvals.

Quantifiable outcome

• Successfully developed more than 20 NDA/BLA/MAA dossiers for FDA and EMA regulatory submissions
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered strategic, core and minor.

• AICROS (Association of International Clinical Research Organizations)strategicStrategic or Co-development Partner · 1 January 2018AICROS is a consortium of small to mid-size CROs that collaborate to provide clinical research services to the biotechnology, pharmaceutical and device industries worldwide. PROMETRIKA joined AICROS in 2018.
• MedidatacoreTechnology or IntegrationMedidata Services Provider with certified expertise in Medidata Rave EDC platform and Medidata Patient Cloud platform. PROMETRIKA was the first Medidata CRO partner accredited in the Medidata Patient Cloud platform and has managed studies using Medidata Rave since 2013.
• CDISCcoreTechnology or IntegrationPlatinum Member of CDISC (Clinical Data Interchange Standards Consortium). PROMETRIKA has the opportunity to sit on the CDISC Advisory Council (CAC), which plays an important role in shaping CDISC's development and direction. Representatives contribute industry expertise and share real-world implementation experiences.
• Local CROs in 80+ CountriescoreChannel Partner/ Reseller/ DistributorPROMETRIKA has formed strategic partnerships with like-minded and similarly sized local CROs in over 80 countries on 5 continents. These relationships optimize the management of key logistic concerns such as time zone differences, supply chain consistency, language barriers, and ethical and cultural considerations for international clinical trials.
• MassBiominorGTM or Marketing PartnerPROMETRIKA proudly sponsors MassBio's Rare Disease Day Forum and other MassBio events, demonstrating commitment to the Massachusetts biotech community and rare disease research.
• Beacon AcademyminorOthersPROMETRIKA participates as a corporate Sponsor in Beacon Academy's Spring Celebration fundraising event. The company also donated interview attire and winter jackets to Beacon students through the 'Swap It' volunteer event. Part of PROMETRIKA with a Purpose Initiative supporting educational equity.
• Community ServingsminorOthersPROMETRIKA employees volunteer at Community Servings in Jamaica Plain, a nonprofit that provides medically-tailored meals to people in Massachusetts and Rhode Island experiencing critical and chronic illnesses.
• Tutoring Plus of CambridgeminorOthersPROMETRIKA partnered with Tutoring Plus of Cambridge, a local nonprofit providing after-school tutoring and mentoring programs for Cambridge youths since 1964, serving about 175 students.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medpace: Mid-size, full-service clinical CRO focused on biotech and small-to-mid pharma sponsors, particularly in oncology, rare disease, and metabolic indications. Directly comparable to PROMETRIKA in target customer profile, full-service model, and therapeutic-area focus.
• Worldwide Clinical Trials: Mid-size global CRO offering full-service clinical development, data management, biostatistics, and regulatory services with therapeutic expertise in CNS, oncology, and rare diseases. Closely comparable in scale, service breadth, and biotech-centric positioning.
• Premier Research: Mid-size CRO specializing in rare disease, oncology, and pediatric trials for biotech and medical device sponsors. Similar therapeutic-area depth and full-service offering make it one of the closest head-to-head comparables.
• Celerion: Clinical research services provider focused on early-phase clinical pharmacology, biometrics, and bioanalytical work. Comparable in offering data management, biostatistics, and Phase 1 expertise to PROMETRIKA's functional services.

Broad incumbents

• IQVIA: Largest global CRO/clinical services platform with end-to-end clinical development, real-world evidence, and technology offerings. Competes with PROMETRIKA for biotech and pharma trials but at significantly greater scale and broader service breadth.
• ICON plc: Global CRO with full-service clinical development, labs, and data services after acquiring PRA Health Sciences. Overlaps with PROMETRIKA across biostatistics, data management, and trial operations but serves a broader customer mix.
• Labcorp Drug Development (Fortrea): Large clinical development and central laboratory services provider (now Fortrea) offering full-service CRO capabilities to pharma and biotech. Directly comparable in CRO service breadth but at substantially greater scale.
• Charles River Laboratories: Major preclinical and clinical CRO with a Discovery & Safety Assessment plus Research Models & Services portfolio. Adjacent competitor on the clinical side, particularly for biotech sponsors needing integrated early- to mid-stage development.
• Parexel International: Large global CRO (currently private following EQT/GS take-private) offering full-service clinical development, regulatory, and biostatistics services to pharma and biotech. Overlaps with PROMETRIKA's therapeutic breadth and FDA/EMA submission expertise.

Emerging players

• Tigermed (Hangzhou Tigermed): Chinese-headquartered full-service CRO expanding aggressively into U.S. and European biotech markets with clinical operations, biostatistics, and regulatory services. Competes with PROMETRIKA for global biotech trials at competitive price points.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/PrometrikaCRO
• Facebookfacebook.com/prometrikallc
• LinkedInlinkedin.com/company/prometrika-llc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 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 Prometrika