What We Do

Clin-Assist, LLC partners with our clients to provide the customized support necessary to quickly and effectively execute clinical or pre-clinical research studies. Our accomplished team offers a personalized experience to meet client-specific needs. 

GENERAL SERVICES
Full service clinical trial management including, but not limited to:

• General study oversight
• Study execution from site identification and qualification through study closeout and the final report
• Monitoring services
• Complete management of independent committees (e.g., Data Safety and Monitoring, Clinical Events)
• Adverse Event management
• Data handing
• Development of clinical study infrastructure (e.g., SOPs, monitoring plan, study guide)

QUALITY ASSURANCE SERVICES
Clin-Assist, LLC is experienced in managing clinical and pre-clinical research activities according to applicable regulations and ethical standards.  Clin-Assist, LLC has an existing and proven infrastructure that our clients are able to leverage.  The existing processes and procedure were developed to ensure compliance with governing regulations and ethical standards such as:   

• Code of Federal Regulations 21 Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies
• Code of Federal Regulations 21 Part 812, Investigational Device Exemption 
• Code of Federal Regulations 21 Part 50, Protection of Human Rights
• International Organization of Standards 14155,  Clinical Investigations of Medical Devices for Human Subjects Part 1: General Requirements
• International Organization of Standards 14155,  Clinical Investigations of Medical Devices for Human Subjects Part 2: Clinical Investigation Plans
• Declaration of Helsinki
• Belmont Report
• E6 Consolidated Good Clinical Practices
• Medical Device Directive - 94/42/EEC 
• 21 CFR 812.2(b). Abbreviated Requirements (NSR studies)