Professional Education and Research Institute

What Professional Education and Research Institute does

Professional Education and Research Institute (PERI) is a privately held, boutique Contract Research Organization (CRO) founded in 2005 and headquartered in Blue Ash, Ohio. The company manages Phase I through Phase IV clinical trials for biologics, drugs, and medical devices, with a deep specialization in lower extremity and wound care indications—particularly diabetic foot ulcers, venous leg disease, peripheral neuropathy, peripheral vascular disease, and gene therapy—and has expanded into diabetes, plastic surgery, CNS, metabolic, endocrine, and rare disease trials. PERI's sponsor base spans pharmaceutical, biotechnology, and medical device companies as well as academic institutions across North America, Europe, Asia, and Australia.

PERI's service portfolio covers the full trial lifecycle: clinical trial management built on a customizable CTMS integrated with EDC and IWRS, clinical monitoring, CDISC-compliant data management with in-house EDC build capabilities, medical writing, regulatory and IRB submissions, scientific and strategic development, trial rescue, and endpoint/safety board services. The company operates through a network of premier US-based clinical research sites with established patient recruitment capabilities, and differentiates through a publication track record of more than 50 lower extremity articles in top peer-reviewed medical journals, including award-winning research presented at SAWC conferences.

Commercially, PERI generates revenue through professional services contracts with enterprise sponsors on a quote-based, customized basis; pricing is not publicly disclosed. The company is founder-led by Dr. Charles M. Zelen with an operating leadership team that includes COO Susan Romberg (formerly SVP at Premier Research) and Director of Business Development Nicole Fernandez. There is no disclosed external institutional or venture capital ownership, and the firm is positioned as a high-touch, niche specialist rather than a scaled, technology-led CRO.

Name

Professional Education and Research Institute

Legal name

Professional Education and Research Institute, LLC

Website

https://periedu.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

PERI is a privately held, boutique CRO founded in 2005 that manages Phase I–IV clinical trials in biologics, drugs, and devices, with deep specialization in lower extremity and wound care indications for global pharma, biotech, and medical device sponsors.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industry

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

Keywords

• Clinical trial management
• Contract research organization
• Clinical monitoring services
• Medical writing services
• Data management

Headquarters

HQ city

Ohio

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, Others

Revenue model

1. Contract Research Organization Services: PERI provides Phase I through Phase IV clinical trial management services for biologics, drugs, and devices. Revenue is generated through professional services contracts with pharmaceutical, biotechnology, medical device companies, and academic institutions. Services include clinical trial management, clinical monitoring, medical writing, data management, regulatory support, site selection, and trial rescue.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

PERI is a boutique Contract Research Organization (CRO) that manages Phase I through Phase IV clinical trials for biologics, drugs, and devices on behalf of pharmaceutical, biotechnology, medical device, and academic sponsors worldwide. The company delivers an integrated suite of services — clinical trial management, clinical monitoring, medical writing, data management, regulatory/IRB submissions, scientific and strategic development, trial rescue, and safety/endpoint validation — with recognized indication specialization in lower extremity and wound care, particularly diabetic foot ulcers.

Product overview

PERI is a boutique Contract Research Organization (CRO) founded in 2005 that offers an integrated suite of clinical trial services spanning Phase I through Phase IV for biologics, drugs, and devices. The company's core portfolio includes Clinical Trial Management (with integrated CTMS and EDC), Clinical Monitoring, Medical Writing, Data Management (with in-house EDC build capabilities), Regulatory/IRB Submissions, Scientific & Strategic Development, Trial Rescue, and Safety/Endpoint Validation services. PERI operates a network of premier clinical research sites across the United States. The company specializes in lower extremity conditions (diabetic foot ulcers, venous leg disease, peripheral neuropathy, peripheral vascular disease, gene therapy) and has expanded to other indications including diabetes, plastic surgery, CNS, metabolic, endocrine, and rare disease. The services work together as an integrated offering with PERI managing the complete trial lifecycle from startup through close-out.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trial Management Effective clinical trial management including customizable Clinical Trial Management System (CTMS) integrated with EDC for study tracking, document workflow, and quality management across Phase I through Phase IV trials for pharmaceutical, biotechnology, medical device, and academic sponsors.
• Clinical Monitoring Clinical Research Associate (CRA) monitoring services with nationally located staff averaging three protocols per CRA, balancing central data review, remote, on-site, and targeted monitoring for efficient data monitoring across trial sites.
• Medical Writing Develops manuscripts, white papers, posters, and publications for marketing products to surgeons and payors, including protocol writing and Clinical Study Report (CSR) preparation.
• Data Management Clinical data management with in-house EDC build capabilities, CDISC-compliant CRF design (paper and electronic), database design and validation, medical coding, and integration with external data sources and third-party vendors.
• Regulatory / Start Up & IRB Submissions Supports study start-up through regulatory submissions, IRB management, and established relationships with prominent IRBs for efficient submission handling.
• Scientific & Strategic Development Provides protocol development, manuscript support, clinical study report coordination, key opinion leader meeting coordination, publications, posters, abstracts, and symposiums.
• Trial Rescue Mitigation services for trial issues using evaluation tools to review study operations, identify key issues, and provide strategic feedback to stabilize and turn around clinical trials.
• Additional Offerings Includes Safety Boards (contract committee members, charter development, safety meetings) and Endpoint Validation services (validation committee members, charter development, training), plus partnerships with vendors for digital imaging, pharmacovigilance, and labs.
• Site Network Services Established relationships with premier clinical research sites throughout the United States for quick trial start-ups, streamlined feasibility, site selection, and training with superior patient recruitment capabilities.

Quantifiable outcome

• 72% of Micro Water Jet treated DFUs healed vs 40% with standard sharp debridement
• +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

Feature4 records

Partnerships

Four partnerships are on record, tiered core and flagship.

• Lakewood-Amedex BiotherapeuticscoreStrategic or Co-development Partner · 12 May 2026PERI entered into an agreement with Lakewood-Amedex Biotherapeutics to serve as the CRO for its Phase 2 clinical program of Nu-3, a Bisphosphocin product for treating infected diabetic foot ulcers. The Phase 2 program includes a Phase 2a study comparing 2%, 5%, and 10% gel concentrations and a Phase 2b study evaluating different dosing regimens against placebo.
• MedaxisflagshipStrategic or Co-development Partner · 1 May 2023Award-winning research collaboration with Medaxis on micro water jet technology device for diabetic foot treatment. The multicenter randomized controlled trial showed 72% healing rate versus 40% with standard debridement. Research won 2nd place at SAWC 2023 highest-scoring abstract.
• Compedica Limited (United Kingdom)coreStrategic or Co-development Partner · 26 September 2022PERI worked with Compedica on the OptiPulse active therapy system clinical trial published in the International Wound Journal. The single-arm prospective feasibility study evaluated the device for diabetic foot ulcers with 80% healing rate within 12 weeks.
• Bioventus (formerly Misonix Inc.)coreStrategic or Co-development Partner · 6 July 2022PERI collaborated with Misonix Inc. (now Bioventus) on the TheraSkin trial published in the International Wound Journal. This Level 1 clinical evidence trial showed 76% DFU healing with TheraSkin plus standard of care versus 36% with standard of care alone.

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Premier Research: Mid-size specialty CRO with a medical device and biotech focus, where PERI's COO Susan Romberg was previously SVP of Clinical Data Sciences. Overlapping footprint in device and small-biotech trials makes it the most operationally comparable peer.
• Medpace: Cincinnati, Ohio-based full-service mid-sized CRO focused on small and mid-sized biopharma. Same regional labor pool, overlapping therapeutic area experience (including endocrinology/diabetes-adjacent), and competing for similar specialty sponsor mandates.
• Worldwide Clinical Trials: Private, mid-sized scientific-focused CRO emphasizing complex therapeutic areas and personalized sponsor service — closely analogous boutique/specialty positioning to PERI but with broader indication coverage.
• Clinipace Worldwide: Mid-sized, therapeutically-focused CRO with oncology, rare disease and specialty pharma focus. Comparable in scale and orientation toward smaller, indication-focused sponsors.
• Cato SMS: Boutique CRO offering full-service clinical and biometrics capabilities with a strong oncology and rare-disease tilt. Similar boutique 'high-touch' value proposition to PERI, often considered by mid-sized sponsors evaluating between boutique and big CROs.

Broad incumbents

• IQVIA: World's largest CRO and clinical research services provider, offering full-service Phase I-IV capabilities including in wound care and device studies. Competes for the same sponsor budget but at global scale well beyond PERI's reach.
• Parexel International: Large global CRO with deep biopharma and device trial expertise, often selected by mid-sized sponsors weighing PERI for boutique engagements. Represents the larger alternative that sponsors may escalate to as programs scale.
• ICON plc: Top-tier global CRO offering Phase I-IV clinical and laboratory services across all major therapeutic areas. Direct incumbent competing for Phase 2/3 wound-care and rare-disease sponsors PERI also targets.
• Syneos Health: Large clinical and commercial solutions CRO with biopharma focus, now private following an Elliott Management take-private. Competes for mid-sized sponsor trials in the same Phase 2/3 sweet spot as PERI.

Emerging players

• WCCT Global (a subsidiary of GlobalCare): Mid-sized clinical trial site network and CRO with early-phase and specialty indication experience. Comparable operational profile with internalized investigator sites and a focus on hard-to-recruit indications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 Professional Education and Research Institute