Clinical Services
Transforming a new drug or medical device into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate the clinical development process through all clinical phases.
CSSi LifeSciences expertly provides clinical services for both drug and medical device technologies. Our team has extensive experience in managing clinical research studies, and we understand the unique challenges and requirements of both drug and medical device development. We offer a range of clinical services, including study design and planning, study management, feasibility and competitive assessments, site selection, and investigator training, to support companies in the design and planning of their studies.
We also offer a full range of services across all phases of drug and medical device development. From regulatory affairs to clinical trials and commercialization, we have the expertise and experience to help you succeed.
Our clinical service offerings include:
- Study design and development
- Clinical operations and management
- Site selection and recruitment
- Patient feasibility assessments
- Human factors study design
- Bridging studies to support reference and historical data
- Patient mapping
- Clinical monitoring
- Pharmacovigilance
- Patient recruitment and engagement
- Patient advocacy
- Scientific and medical advisory boards
- Data management and audit
- Biostatistical planning and analysis
- Advisory Boards
- Study drug and supply logistics
- Data Safety Monitoring Committee
- Regulatory affairs and submissions
- REMS program
CSSi LifeSciences provides expert, fully integrated end-to-end clinical operations from study design to closeout.
Contact us today to learn more about how our clinical services can support the development of your product.
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Accelerate timelines and reduce risks.
By bringing the relevant expertise to clinical trial design, planning, and execution, we remove barriers to patient participation, accelerate timelines, and reduce risk.
Strategy and Planning
Each milestone of development has a timeline and cost used to map your business plan and to attract investment. Learn More
Study Documents
We have the experience and expertise to design and develop clinical studies and all required study documents in accordance with the latest GCP and ICH guidelines.
Clinical Site Selection
We have a network of clinical sites that can align with your study objectives to accelerate study start-up.
Study Management
Our clinical operations team has decades of experience in managing and monitoring clinical studies.
Advisory Board
Finding KOLs is challenging for small companies. Leverage our network to connect with the relevant experts to best guide your technological and business development.
From Discovery to Commercialization…