Clinical Research Strategies

What Clinical Research Strategies does

Clinical Research Strategies (CRS) is a privately held US contract research organization and executive management consultancy headquartered in Wexford, Pennsylvania (greater Pittsburgh area), founded circa 2018 (with firmographic records citing 2009). The firm delivers clinical development strategy, regulatory affairs, quality management, CRO and sponsor staffing, human factors studies, policy and innovation advisory, documentation redaction, and, as of February 2026, tech transfer advisory services. Its primary buyers are start-up and mid-size life sciences companies across biotech, medical devices, pharmaceuticals, diagnostics, combination products, and digital therapeutics, supplemented by university tech transfer offices and CROs seeking alliance partnerships.

The core offering sits under a "Life Sciences Consulting" umbrella with eight sub-service lines: Compliance, Governance & Due Diligence; Clinical & Regulatory Affairs; Risk Management & Quality Management Systems; CRO & Sponsor Staffing; Policy & Innovation; Human Factors Studies; Tech Transfer Advisory; and Documentation Redaction Services. CRS maintains two sub-brands — CRS Alliance, a vetted network of CRO and biopharma consulting partners that extends delivery capacity, and CRS Academy, which delivers training and workshops. Delivery is led by a PhD-heavy bench (~15–20 named staff including multiple Pitt-trained PhD scientists) with documented regulatory credentials across FDA 21 CFR 312/812/820, EU MDR, ICH GCP, ISO 13485/14155, MDSAP, and HIPAA/GDPR.

CRS operates a sales-led, relationship-driven GTM targeting founders, CEOs, and regulatory leaders of early- and mid-stage life sciences firms; channels include direct phone/web consultations, targeted content (website, LinkedIn, webinars, published articles in Clinical Leader and DIA journals), and accelerator/university partnerships (CMU, University of Pittsburgh, CNYBAC, M2D2 IMPACT, LifeX). Revenue is generated via professional services fees under project-specific, fit-for-purpose, or ad hoc consulting and staffing engagements at quote-based, non-public pricing. The company is founder-owned, with no disclosed institutional investors, no funding rounds, no parent company, and no public reporting; it has ranked #34 (2022–2023) and #30 (2025) on the Pittsburgh Business Times list of Life Sciences/Medical Device Firms by employee count.

Name

Clinical Research Strategies

Legal name

Clinical Research Strategies, LLC

Website

https://clinicalresearchstrategies.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Clinical Research Strategies is a US-based contract research organization and executive management consultancy providing clinical development, regulatory affairs, quality management, and CRO staffing services to start-up and mid-size life sciences companies, headquartered in Wexford, Pennsylvania.

Ownership category

akta.pro rank

Product category

Clinical Research and Regulatory Affairs Consulting

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA), Clinical Site Start-Up & Activation (Regulatory/Ethics/Contracts) (HLAGACAC), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

Keywords

• Clinical research consulting
• Regulatory affairs services
• Quality management systems
• Medical device compliance
• Clinical trial staffing

Headquarters

HQ city

Wexford

HQ country

United States

HQ region

North America

Offices12 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Consulting Services: CRS generates revenue through consulting fees for clinical development strategy, regulatory affairs, quality management, compliance, and governance services. Services are delivered project-specific, fit-for-purpose, or as ad hoc consulting engagements. The firm also provides staffing services placing experts on clients' teams.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

Clinical Research Strategies is a US-based contract research organization and executive management consultancy that delivers project-specific, fit-for-purpose, and ad hoc clinical research, regulatory affairs, quality management, compliance, and clinical trial staffing services to start-up and mid-size life sciences companies. Offerings span eight service modules including clinical and regulatory affairs, quality and risk management, human factors studies, tech transfer advisory, policy and innovation, documentation redaction, and CRO/sponsor staffing, supported by the CRS Alliance expert network and CRS Academy training program.

Product overview

Clinical Research Strategies is a US-based contract research organization and executive management consultancy offering a unified platform of clinical development and regulatory strategy services for start-up and mid-size life sciences companies. The core offering, Life Sciences Consulting, encompasses multiple integrated service modules including Compliance & Governance, Clinical & Regulatory Affairs, Risk Management & Quality Management Systems, CRO & Sponsor Staffing, Policy & Innovation, Human Factors Studies, Tech Transfer Advisory, and Documentation Redaction Services. CRS Academy provides supplementary training. These services work together to help clients navigate complicated trial operations and regulatory pathways from development through approval.

Differentiator

Problem solved

Functional benefit

Brands

• CRS Alliance: A network of vetted contract research organizations (CROs) and experts meeting strict quality, ethics, and experience criteria.
• CRS Academy

Products and services

• Life Sciences Consulting Core consulting service providing clinical development strategy, regulatory affairs support, and executive management advisory for start-up and mid-size life sciences companies, delivered as project-specific, fit-for-purpose, ad hoc, or staffing engagements across the full clinical development program.
• Compliance, Governance & Due Diligence Service helping organizations balance integrity and reputation with business performance, including EU MDR compliance, SOP development, governance review, Trial Master File management, and acquisition due diligence assessments, supporting ICH GCP, ISO 14155, 21 CFR 312, and 21 CFR 812 compliance.
• Clinical & Regulatory Affairs Clinical development planning and regulatory strategy services including protocol writing, investigator brochures, literature reviews, FDA pre-IND/Q-sub meetings, and regulatory agent representation for drugs, biologics, and medical devices.
• Risk Management & Quality Management Systems Quality system implementation and improvement services covering FDA 21 CFR 820, ISO 13485, MDR, MDSAP, internal audits, supplier management, remediation, post-market surveillance, and data privacy compliance.
• CRO & Sponsor Staffing Clinical trial team staffing and CRO partnership services including project management, clinical monitoring, quality assurance, scientific writing, medical monitoring, and trial rescue services for drugs, biologics, devices, and diagnostics.
• Policy & Innovation Regulatory science advisory addressing clinical trial reform, EHR-to-EDC interoperability, real-world evidence, blockchain/AI in life sciences, emergency use authorizations, and NIH RADx participation.
• Human Factors Studies Usability studies program ensuring medical devices are safe and effective for use, evaluating critical tasks, product labels, and instructions for use by healthcare practitioners, caregivers, and patients.
• Tech Transfer Advisory University technology commercialization advisory service led by Julie Cramer, PhD, providing regulatory pathway assessments, FDA early interactions, clinical strategy, investor relations, and gap analysis for university-based technologies.
• Documentation Redaction Services Clinical documentation redaction service helping pharmaceutical companies protect proprietary information while complying with international public disclosure regulations requiring trial documentation publication.
• CRS Academy Training and workshop program offering customized presentations on clinical research topics including quality by design, inspection-readiness, risk-based monitoring, regulatory frameworks, and privacy laws.

Quantifiable outcome

• Saved clients over $350,000 through CRO contract negotiation and charge identification
• +2 more outcomes

Named customers9 records

Segments6 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

17 partnerships are on record, tiered core and minor.

• Ginkgo BioworkscoreStrategic or Co-development Partner · 22 December 2025CRS is a corporate partner in the Ginkgo Bioworks-Carnegie Mellon University ARPA-H POSEIDON program to develop a novel cancer screening approach combining synthetic biology with detection technology. The project involves an oral pill with engineered tumor-targeting sensors and a companion at-home urine testing device for early cancer detection.
• Carnegie Mellon University (CMU)coreStrategic or Co-development Partner · 20 October 2025CRS supports two ARPA-H programs with CMU, providing Quality, Regulatory, and Clinical services as part of the ARPA-H Customer Experience Hub Spoke. CMU leads research in synthetic biology and detection technology for healthcare applications.
• ARPA-H Customer Experience HubcoreStrategic or Co-development PartnerCRS is a Spoke member of the ARPA-H Customer Experience Hub, part of a nationwide health innovation network targeting prevention, treatment, and diagnosis needs. CRS contributes Quality, Regulatory, and Clinical services to drive better health outcomes.
• Bestudy GroupminorChannel Partner/ Reseller/ DistributorShanghai-based CRO providing clinical research services for drugs, medical devices, and biological products. CRS alliance partner meeting strict criteria for quality, ethics, and experience in key indications.
• MediLifeminorChannel Partner/ Reseller/ DistributorMedTech and Life-Sciences specialist providing end-to-end support from clinical trial management through commercialization. CRS alliance partner with experience in radiology, cardiology, vaccines, haemophilia, and rare diseases.
• Medical Technology Enterprise Consortium (MTEC)minorStrategic or Co-development Partner501(c)(3) biomedical technology consortium collaborating with government agencies under Other Transaction Agreement. Focuses on medical solutions for military and civilian health. CRS alliance partner.
• PharmaximinorChannel Partner/ Reseller/ DistributorClinical research services provider for biotech, pharmaceutical, and medical device companies across all Phases (I-IV), services and locations (North America, Central Europe and CIS countries). CRS alliance partner.
• Central New York Biotech Accelerator (CNYBAC)minorStrategic or Co-development PartnerCRS is a Service Provider Network member offering Regulatory/Compliance, Risk Management/Quality Systems, Startup Company Support, and University Support services to biotech-related startup companies.
• M2D2 IMPACT AcceleratorminorStrategic or Co-development Partner12-week accelerator program using 1:1 approach connecting startups with resources needed for commercialization. CRS provides educational workshops and expert mentorship as corporate sponsor.
• LifeX - Accelerating Life SciencesminorStrategic or Co-development PartnerCapital growth company de-risking time, resources, and investment for life sciences companies. Focuses on commercialization, capital, infrastructure, and resources. CRS supports Pittsburgh and national ecosystem.
• University of PittsburghminorStrategic or Co-development PartnerCRS participates in Pitt's Community of Innovators initiative, presenting educational sessions and mentorship to support researchers and staff in translational research. Team members include Pitt alumni.
• Advarra ConsultingminorImplementation/ SI/ Consulting PartnerStrategic collaboration with Advarra for regulatory consulting services. Alethea Wieland serves as partner to Advarra Consulting.
• Ayd BioPharma Consulting GroupminorChannel Partner/ Reseller/ DistributorDrug development consulting partner within CRS Alliance network.
• Star Biopharma ConsultingminorChannel Partner/ Reseller/ DistributorBiopharma consulting partner within CRS Alliance network.
• MedSurgPIminorStrategic or Co-development PartnerPhysician experts partner within CRS Alliance network.
• DTS Language ServicesminorChannel Partner/ Reseller/ DistributorTranslations partner within CRS Alliance network.
• Simpson | McCradyminorChannel Partner/ Reseller/ DistributorLife sciences and clinical trial insurance partner within CRS Alliance network.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Atlantic Research Group: Atlantic Research Group is a niche CRO providing clinical operations, regulatory affairs, and biometrics services primarily to emerging biotech and rare disease sponsors. It is comparable to CRS in size, target market, and service mix.
• ProPharma Group: ProPharma Group is a life sciences regulatory and clinical consulting firm providing regulatory affairs, pharmacovigilance, compliance, and clinical research services to pharma, biotech, and medical device companies. It directly competes with CRS in regulatory affairs consulting and CRO services for small/mid-size life sciences clients.
• Veristat: Veristat is a CRO specializing in clinical trial design, biostatistics, regulatory affairs, and medical writing for emerging biotechs and small/mid-size pharma. It targets the same start-up/mid-size sponsor segment as CRS and competes for clinical strategy and regulatory pathway engagements.
• Advarra Consulting: Advarra provides IRB, biosafety, and clinical research consulting services, including regulatory consulting to sponsors and CROs. CRS's President Alethea Wieland also serves as an Advarra partner, indicating overlapping service lines and customer base in regulatory affairs for emerging biotech.
• Premier Research: Premier Research is a mid-size CRO providing clinical development, regulatory, and consulting services focused on small/mid-size biotech and medical device companies. It competes with CRS for the same emerging-sponsor segment across regulatory affairs, trial design, and quality management.
• NAMSA: NAMSA is a medical device-focused CRO offering regulatory, clinical, and quality consulting services for device manufacturers globally. It directly competes with CRS on medical device regulatory strategy, FDA pathways, quality systems, and human factors studies.

Broad incumbents

• Medpace Holdings: Medpace is a publicly traded mid-size CRO purpose-built for small/mid-size biotech and medical device sponsors, providing full-service clinical trial execution with embedded regulatory support. It is a much larger, broader incumbent competing for the same emerging-sponsor client base as CRS.

Emerging players

• ComplianceQuest: ComplianceQuest provides quality management system software and consulting for life sciences companies, including FDA 21 CFR 820 and ISO 13485 compliance. It overlaps with CRS's quality systems and QMS implementation services for life sciences manufacturers.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/clinical-research-strategies

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 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 Clinical Research Strategies