Research & Consultation
General
NiaMedic’s team consists of highly experienced research and clinical professionals with more than a decade of cannabis research experience. Based in Israel, with operations in the USA and the EU, NiaMedic provides a very unique, multinational, one of a kind, research platform for product and cultivation companies seeking a clinical field to test their products and/or cultivars.
We have a very unique and in-depth understanding of the challenges of clinical trials and studies, and we are experienced in designing, managing, and executing clinical trials and studies. Our ability to provide clinical research services from A to Z, as a one stop shop layout, ensures our clients peace of mind.
Clinical Research
Niamedic provides unique and high-quality clinical research services and solutions for companies seeking a clinical field to test their products. We provide a one stop shop solution for our clients, which includes every phase of the clinical trial/study, such as:
Clinical research design
Strategic planning is required during the earliest stages of clinical research. NiaMedic’s professionals clarify the objectives and goals of each clinical study, based on the selected medical indication and product. From there, we design and build a complete strategic plan for execution for each clinical trial or study.
Medical writing
All relevant requirements, including building the research protocols and the procedure to be used in the clinical research and the CRF. The protocols shall be written at the highest standards in order to ensure the successful management of the clinical research and the quality of the results. The protocols also include the required equipment, safety matters, results measurements, and reporting standards. This includes statistical analysis and rules for pre-defining and documenting excluded data to avoid bias.
Clinical Data Management (CDM) and Clinical Programming
This is a critical phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical research. This keeps the number of errors and missing data as low as possible and gathers maximum data for analysis. Team members of CDM are actively involved in all stages of clinical trials right from inception to completion. The data should also meet the applicable regulatory requirements specified for data quality.
Project Management, Site Management, and Clinical Monitoring
Effective Project Management and Site Management are an essential aspect of clinical research execution and in ensuring clinical research success. NiaMedic’s Project Management, Site Management, and Oversight services allow us to effectively recruit, treat, and retain patients while ensuring quality of regulatory compliance, medical protocol adherence, protection of patients’ rights, safety, and overall project management. We manage the clinical research process with precision to guarantee the research stays within the timeline and budget requirements.
Patient Recruitment
the patient recruitment practice is not a single process – it includes a range of clinical research procedures. Patient recruitment is the most time-consuming aspect of the clinical research process. The leading cause of missed clinical research deadlines is patient recruitment, taking up to 30%. Patient recruitment efficiency enables pharmaceutical and medical device companies an opportunity to accelerate the pace of the clinical research – making it possible to reduce time to market.
Statistical Analyses
Double Programming - NiaMedic provides Statistical Analyses services by qualified statistical programmers, which have been involved in a variety of clinical studies of different scales. Keeping our team up-to-date on all regulatory standards is very important in order to perform sound data analyses. We support our clients in the development and validation of outputs for clinical study reports and submission ready deliverables.
Consultation/R&D
Our consultation packages provide a wide spectrum of services that will save your company time and money when you develop a new product. Product development in the cannabis space could be tricky and costly, and our job is to save you all common mistakes. Our cannabis protocols consist of data from over 12,000 patients over 9 years of cannabis treatment in both Israel and the US.
Formulation Development - Up to 15 different cannabinoids & terpenes
Bioavailability Tests - PK/PD
Product Safety & Efficacy