At Clin-Assist, LLC we believe every company, product, and team is unique and requires a tailored approach to their clinical efforts. A breakdown of our full-range, integrated, and personalized methods to clinical research operations is as follows:
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 nonclinical consulting.
Clinical Operations: Clin-Assist provides a unique approach to clinical trial management and support. We can act as a full-service CRO or operate 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]. Because Clin-Assist aims to establish a partnership on all projects, acting as the management resource for other CROs is often a service provided.
Data Management: Clin-Assist has many years of Data Management experience. We provide a broad range of services from initial establishment of a new Data Management system on behalf of a Sponsor, to providing full service Data Management from Case Report Form (CRF) and database development through final database lock.
Training: Clin-Assist provides training for all levels of clinical research personnel. From those looking to start a career in clinical trials to company executives looking to further understand the requirements and activities necessary to conduct a compliant clinical study. Customized training programs may be developed specific to your team and skill level, or existing training programs are available.
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.
Study Recruitment: Clin-Assist provides facilitation of recruitment for study participants including identifying potential patients, acting as patient point of contact, and screening for eligibility to participate.
Don’t see what you’re looking for? Contact our clinical research management team to learn more about what we offer and how we can help you achieve the solution you need to evaluate your technology in a clinical or nonclinical setting. We are a small team that aims to partner with our clients to provide a customized approach that will best meet your study needs.