Stark Associates

What Stark Associates does

Stark Associates LLC is a Piscataway, New Jersey-headquartered private company founded in 2016 that operates as a full-service Contract Research Organization (CRO) alongside an IT services and proprietary software business, serving pharmaceutical, biotechnology, medical device, consumer healthcare, and cosmetics clients across the full product development lifecycle. The company's service portfolio spans clinical research (trial management, monitoring, audit, biostatistics, clinical data management, project management), regulatory affairs (eCTD submissions, EU MDR/IVDR compliance, UDI, multi-jurisdictional submissions), pharmacovigilance, validation, and API/RLD sourcing, with additional IT services and strategic resourcing for IT and clinical professionals.

The core proprietary technology is Stark Comply, a cloud-based Quality Management & Compliance (QMS) platform designed for medical device manufacturers. It is 21 CFR Part 11 compliant and offers CAPA and NCR automation, complaints management, automated workflows, approvals, notifications, and centralized document control, replacing paper-based quality systems. The broader technology stack includes expertise in EDC systems such as Medidata RAVE and Oracle, SAS-based biostatistics, and CDISC SDTM/CDASH data conversion. The company claims multi-jurisdictional regulatory compliance coverage spanning USFDA, EUGMP, UK MHRA, PMDA, Korea FDA, Health Canada, COFEPRIS, and ANVISA.

The business model combines professional services (CRO and IT) sold via direct enterprise sales and conference-driven lead generation (DCAT, INTERPHEX, CPhI, DIA) with subscription/recurring revenue from Stark Comply licensing to medical device manufacturers. Delivery follows an onshore/offshore model with US headquarters in Piscataway, NJ and operational hubs in Visakhapatnam and Hyderabad, India. The company is privately held, bootstrapped, and founder-owned with no disclosed external investment, and serves 51-100 employees.

Name

Stark Associates

Legal name

Stark Associates LLC

Website

https://starkassociatesllc.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

51–100 employees

Short description

Stark Associates is a Piscataway, NJ-based full-service CRO and IT services firm founded in 2016, serving pharmaceutical, biotech, medical device, consumer healthcare, and cosmetics clients with clinical research, regulatory affairs, pharmacovigilance, biostatistics, and its proprietary Stark Comply QMS software, delivered via US and India operations.

Ownership category

akta.pro rank

Product category

Contract Research Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169), Computer Systems Design and Related Services (54151)

SIC

Services-Health Services (8000), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

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

Keywords

• Contract research services
• Regulatory affairs consulting
• Pharmacovigilance services
• Clinical data management
• Quality management software

Headquarters

HQ city

Piscataway

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CRO Services: Full-length Contract Research Organization services including clinical research, regulatory affairs, pharmacovigilance, biostatistics, validation, trial management, trial monitoring, clinical project management, audit, and API/RLD sourcing. Services support all phases of product development for pharmaceutical, biotech, medical device, consumer healthcare and cosmetics clients.
2. IT Services: Custom application development, software tools for life sciences industry, testing, maintenance and support services, cloud solutions, automation, and enterprise applications for life science organizations.
3. Strategic Resourcing / Staffing: Contract and full-time placement of IT and Healthcare/Clinical professionals to meet client business needs. Includes clinical staffing and IT staffing services.
4. Software Licensing (Stark Comply): Cloud-based QMS software platform (Stark Comply) provided to medical device manufacturers for compliance and quality management.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

Stark Associates is a full-service Contract Research Organization (CRO) providing clinical research, regulatory affairs, pharmacovigilance, biostatistics, validation, clinical data management, audit, trial monitoring and management, API/RLD sourcing, and EU MDR compliance services to pharmaceutical, biotech, medical device, consumer healthcare and cosmetics companies. The company complements its CRO services with IT services (custom application development, software testing, maintenance and support) and strategic resourcing (clinical and IT staffing), and sells Stark Comply, a cloud-based 21 CFR Part 11 compliant QMS platform for medical device manufacturers.

Product overview

Stark Associates is a full-service global Pharma & IT Services Company offering a portfolio of clinical research and technology solutions. The company provides two primary product lines: (1) Stark Comply, a cloud-based Quality Management & Compliance platform (QMS) designed for medical device manufacturers with 21 CFR Part 11 compliance; and (2) comprehensive Clinical Research Services covering trial management, regulatory affairs, pharmacovigilance, biostatistics, validation, and API/RLD sourcing. Additionally, IT Services include custom application development, software testing, and strategic resourcing for IT and healthcare professionals. The Stark Comply platform serves as the core software product, while clinical and IT services are delivered through skilled professional teams.

Differentiator

Problem solved

Functional benefit

Brands

• Stark Comply: Cloud-based Quality Management & Compliance platform for medical device manufacturers, 21 CFR Part 11 compliant system for regulatory compliance.

Products and services

• Stark Comply
• Clinical Research Services
• Regulatory Affairs Services
• Pharmacovigilance Services
• Biostatistics Services
• Validation Services
• API & RLD Sourcing
• IT Services
• Strategic Resourcing
• EU MDR Compliance Services
• Audit Services
• Trial Monitoring
• Trial Management
• Clinical Project Management
• Clinical Data Management
• Quality Services

Quantifiable outcome

• Studies have shown that 'Project Management' has contributed to almost 20% increase in achieving clinical project goals
• +1 more outcomes

Named customers4 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core.

• New Jersey Software Company (Government & Military Solution Provider)coreStrategic or Co-development Partner · 1 June 2018Stark entered into a Master Service Agreement (MSA) with a New Jersey based software company specializing in government and military solutions. Stark is providing full-length pharmaceutical SME (Subject Matter Expert) and partial development services for the development of pharmaceutical compliance and auditing modules in their proprietary product.
• Pharmaceutical Giant (Multinational)coreStrategic or Co-development Partner · 1 March 2018As part of strategic expansion, Stark teamed with a multinational pharmaceutical giant to provide consulting services for eCTD submissions and Regulatory writing. This partnership enables Stark to offer regulatory submission services leveraging the client's global presence.
• Pharma Giant (Milwaukee, WI)coreStrategic or Co-development Partner · 1 September 2016Stark Associates partnered with a pharmaceutical giant headquartered in Milwaukee, WI to fill their contract staffing needs. This partnership demonstrates Stark's capability to provide qualified clinical and IT professionals to major pharmaceutical companies on a contract basis.

Scale indicators3 records

Recent moves8 records

Expansion highlights6 records

Others

• Veeva Systems: Leading life sciences cloud platform vendor including Vault Quality, Vault CTMS, and Vault eTMF. Directly comparable as a competitor to Stark's proprietary Stark Comply QMS platform in the medical device compliance software category.

Direct peers

• Medpace Holdings: Mid-tier, full-service clinical CRO offering Phase I–IV trial management, regulatory affairs, biometrics, and pharmacovigilance with a mixed onshore/offshore delivery model. Highly comparable to Stark in service breadth and target customer (mid-to-large pharma/biotech), though materially larger in scale and publicly listed.
• Veristat: Clinical CRO offering biostatistics, clinical operations, regulatory, and medical writing services, with strong emphasis on regulatory submission support (eCTD). Closely comparable to Stark's regulatory affairs and medical writing service lines.
• Worldwide Clinical Trials: Mid-sized global CRO focused on clinical operations, biostatistics, pharmacovigilance, and regulatory consulting across multiple therapeutic areas. Comparable to Stark in service mix and therapeutic breadth, with a similar emphasis on mid-tier pharma sponsors.
• CTI Clinical Trial and Consulting Services: Specialty and full-service CRO providing clinical trial management, regulatory, and pharmacovigilance services across a range of therapeutic areas, including rare disease and oncology. Comparable to Stark's mid-tier, multi-TA full-service CRO positioning.

Broad incumbents

• IQVIA: Largest global CRO and life sciences services provider with end-to-end clinical, regulatory, technology, and data offerings. Overlaps with Stark across nearly every service line but at vastly greater scale, technology integration, and data asset depth.
• Labcorp Drug Development (Fortrea): Large-scale clinical CRO and central lab services provider spun out from Labcorp. Competes with Stark in clinical trial management, central lab, and biostatistics services for pharma sponsors.
• Parexel International: Large global CRO with deep regulatory affairs, clinical, biostatistics, and pharmacovigilance capabilities. Overlaps heavily with Stark's service portfolio, particularly in eCTD submissions and global regulatory consulting.
• ICON plc: Major global CRO offering clinical research, laboratory, regulatory, and consulting services across all phases of drug and device development. Competes with Stark for enterprise pharma CRO work, particularly in clinical operations and biometrics.

Emerging players

• Novum Pharmaceutical Research Services: Smaller specialty CRO with bioequivalence, clinical, and analytical services. Comparable in size and offshore-friendly delivery to Stark, though more narrowly focused on BA/BE and early-phase studies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/StarkAssociates

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

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 Stark Associates