ClinTrialSolutions, LLC
↗Roswell, Georgia, USA
ClinTrialSolutions is a boutique Contract Research Organization (CRO) and consulting firm specializing in clinical, regulatory, and quality system services for the medical device and pharmaceutical industries. The company focuses on accelerating market access for small to mid-sized firms by providing strategic clinical trial management and regulatory pathway assessments.
The firm offers a comprehensive suite of services including clinical strategy development, gap analysis of pre-clinical data, medical writing (CER, PMCF, PSUR), and quality management system implementation (ISO 13485 and ISO 14155). They are particularly noted for their expertise in ophthalmology and 'fractional' Chief Medical Officer services for startups.
CLASSIFICATION
Company Type:CRO
Therapeutic Areas:
Industry:Medical Devices
Sub-Industry:Clinical Research Organization (CRO)
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$5M
Founded:2019
Ownership:private
Status:operating
FUNDING
Stage:Bootstrapped/Self-funded
PIPELINE
Stage:Commercial
Lead Drug Stage:N/A (Service Provider)
Modalities:Medical Devices, Diagnostics, Digital Health
Active Trials:5
Trial Phases:Phase 1: 1 | Phase 2: 2 | Phase 3: 2
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Key Partnerships:Greenlight Guru (Quality Management Software partnership), Visioneering Technologies, Inc. (Clinical Research Partner)
COMPETITION
Position:Niche Player
Competitors:MCRA (Musculoskeletal Clinical Regulatory Advisers), NAMSA, RQM+, Emergo by UL
LEADERSHIP
Key Executives:
Sally M. Dillehay - CEO & President
Scientific Founders:Sally M. Dillehay
LINKS
Website:clintrialsolutions.org
LinkedIn:LinkedIn Profile
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