In collaboration with its strategic partners, ICCI designs, manages and provides services to conduct clinical trials on cannabis, for both public and private initiatives. With its expertise founded on over 200 completed clinical studies, and over 200 additional on-going studies, ICCI is proficient at incorporating innovative research techniques to meet the unique design, management and data analysis needs of cannabis-related clinical trials.
ICCI’s Contract Research Organization (CRO) Services provide guidance in the following areas:
ICCI will help you design a customized clinical trial protocol including the background, objectives, design, methodology, and logistics for the study.
ICCI and its strategic partners will help you develop cannabis-based pharmaceuticals using cutting-edge biotechnology. Providing guidance and collaboration throughout the entire process, ICCI can take you from discovery through to patent application and receipt, and authorization to manufacture the final product.
Biological Assay Development
Your final product needs to be analyzed to determine its composition and the exact concentrations of its constituents. Moreover, it requires testing using appropriate bioactivity models, to provide accurate dose-response data. ICCI scientists will assist with the development of all required assays.
Clinical Regulatory Affairs
The ICCI team’s extensive knowledge of clinical regulatory affairs is very useful for navigating through national regulatory requirements and will help ensure a straightforward product submission process.
Clinical Trial Design
ICCI experts can guide you on creating a well designed clinical trial to ensure that specific outcomes of interest are achieved.
A final product requires preclinical research before being tested in humans. Preclinical research includes both in vitro and in vivo testing to assess the safety and toxicity profiles, as well as the pharmacokinetic and pharmacodynamic properties of the product. ICCI scientists will perform this research using established ICCI Patient Focused Certification Program: Good Laboratory Practices Standards methods, which are designed to provide results with exceptional accuracy.
ICCI will help you find participants for your clinical trial.
Once the preclinical research is complete, research in humans, or clinical research, can begin. Clinical research on a product is conducted in four phases, with Phase I and Phase II trials focused on product safety and Phase III and Phase IV trials focused on efficacy. ICCI has extensive experience and know-how in conducting clinical research, and our expertise will help you avoid some of the difficulties that can often arise in this process.
Clinical Trials Management
The ICCI CRO team will manage the clinical trial process from start to finish on your behalf.
ICCI’s Patient Focused Certification (PFC) program provides accredited analytical and bioanalytical product testing so you can rest assured that your products are safe and consistent.
The ICCI CRO team will manage the pharmacovigilance requirements for your product by monitoring, assessing, and documenting reported short and long-term adverse effects, in order to help prevent their occurrence.
Data Capture & Management
ICCI’s Big Data Management team ensures the availability of high-quality data, which is delivered through validation and verification procedures.
After the completion of your research study, the ICCI team will perform all applicable statistical data analysis for your study.
Any apparatus used for research, diagnostic or therapeutic purposes has to be properly registered as an up-to-date medical device. ICCI will provide the oversight needed to ensure compliance of your medical devices.
ICCI’s team of medical writers will efficiently author and publish the outcomes of your clinical trial. The content can be tailored to meet your requirements and specifications.
Once your product is finalized, ICCI will create an effective product launch strategy that will expedite the availability of your product in both domestic and international markets.