© 2017  Clin-Assist, LLC

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Early Development:  Clin-Assist specializes in early development, providing a broad range of support services including First-in-human clinical trials and early phase studies, as well as non-clinical (aka pre-clinical) consulting services.  

Clinical Operations:  Clin-Assist provides a unique approach to clinical trial management and support.  We provide full service typical of a CRO, but as part of the client’s expanded team, stepping in as a fully functional Clinical Affairs department. Our goal is to customize to the needs of the project, the client, and the technology.

Regulatory Support:  Clin-Assist has extensive experience partnering with clients in support of regulatory applications, submissions, study reporting, and development, and coordination of clinical and regulatory strategy(ies).

Clinical Quality:  Development of clinical quality systems.  Clin-Assist has an established and proven quality system that can be leveraged by clients.  Clin-Assist also provides auditing services, clinical study clean-up, and other Quality Assurance services.  As with our Clinical and Regulatory services, Clin-Assist is able to customize services to meet the project specific needs.

Committee and Core Lab Management:  Overall set-up and management of study committees [Clinical Events Committee, Data and Safety Monitoring Board, independent physician reviewer(s), core labs and other research organizations]. 

 

CRO Management: Clin-Assist acts as a fully-operational Clinical Affairs department and is often hired as a management resource to oversee global CRO or other CRO operations.

Data Management:  Clin-Assist has extensive Data Management experience.  We provide a broad range of services from initial establishment of a new Data Management system to providing full-service Data Management from database development through final database lock. Our Data Management approach is flexible and is based upon project needs.  For example, for a small study, MSExcel may be sufficient.  

Training:  Clin-Assist provides training for all skill levels.  From those looking to start a career in research to company executives interested in understanding top-line resources and requirements for execution of a clinical trial.  Training may be customized to your team and skill level or exiting training may be leveraged. 

Study Remedy and Recovery:  Clin-Assist has extensive experience in the assessment, identification of findings, recommendations for resolution, and addressing of non-compliance issues, in an effort to ensure study data are usable for regulatory submissions or other purposes.  Clin-Assist has effectively salvaged multiple clinical trials resulting in a positive outcome for clients.  

Study Recruitment: Clin-Assist provides recruitment materials, a recruitment program and/or active recruitment services.  From advertising to on-line screening to active screening and confirmation of eligibility.  As with other services, Clin-Assist i modifies each recruitment effort to meet study needs.  

Study Coordination - For clinical sites or investigators that are new to research, Clin-Assist is well-versed in providing support from training and "hand holding" to acting as a fully operational central coordination center.  For non-invasive procedures, Clin-Assist can also act as the enrollment facility for subject enrollment and follow up.  

Don't see what you're looking for? Contact our clinical research management team to learn more about our team and how we might be able to help you achieve your product development goals!  

 

Primary Areas of Service
Services Overview
  • Early Development 

  • Clinical Operations 

  • Regulatory Support 

  • Audit/Audit Readiness

  • Clinical Quality 

  • Committee and Core Lab Management

  • CRO Management

  • Quality Management System (QMS)

  • Data Management 

  • Training 

  • Study Remedy and Recovery 

  • Clinical Strategy Development

  • Central Study Coordination Center

  • General Clinical Research Consulting

  • New to Research Training for Executives