Clinical Services

Transforming a new drug or medical device technology into a treatment opportunity is a complex, expensive, and time-sensitive process. We can help you navigate the clinical development process through all clinical phases. 

Service Offerings

Our team has extensive clinical development experience, and we offer a full range of services across all phases of drug and medical device development. From regulatory affairs to clinical trials and market access for commercialization, we have the expertise and experience to help you succeed.

Documentation Management

Our clinical service offerings include:

  • Early phase benchmarking and characterization
    • Identify suitable endpoints and study designs
  • Study planning and early concept development and design
    • Scientific assumptions, preclinical data, risk mapping and market opportunity
  • Clinical study competitive landscape
  • Feasibility assessment and return on investment of clinical trial concepts
  • Clinical operations and management
    • Study start-up acceleration
    • Enhancing physician participation
    • Accelerating patient recruitment
  • Physician and patient feasibility assessments
  • Bridging study characterization to support reference and historical data
  • Patient mapping
  • Patient advocacy planning
  • Scientific and medical advisory boards
  • Risk assessment and mitigation
  • REMS program planning and consultation

CSSi LifeSciences has partnered with leading clinical research organizations (CROs) to support clinical studies worldwide, regardless of clinical phase. Our strategic partners are able to provide an integrated solution that is tailored to meet our client needs. Meet our clinical CRO partners who have the proven ability to execute your study.

  • Tigermed USA
  • CMIC Group
  • Validcare
  • Meditip
  • New Day Diagnostics

Contact us today to learn more about how our clinical services can support the development of your product.

View All Services

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

Strategy and Planning

Each milestone of development has a timeline and cost used to map your business plan and to attract investment. Learn More

Documentation Management

Study Documents

We have the experience and expertise to design and develop the clinical studies in accordance with the latest GCP and ICH guidelines. 

Patient Recruitment

Clinical Site Selection

We have a network of clinical sites that can align with your study objectives to accelerate study start-up.

Clinical Site Selection

Study Management

Our CRO partners ​have decades of experience in managing and monitoring ​clinical studies. 

Advisory Board

Advisory Board

Finding KOLs ​is challenging​​​ for small companies. Leverage our network to connect you with the ​relevant​​​​ ​experts to best guide your technological and business development.

From Discovery to Commercialization…

What innovative thinkers do in detail.