Clinical Research Services
NiaMedic is a healthcare and research company.
NiaMedic’s team consists of highly experienced research and clinical professionals with more than a decade of 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 strains.
NiaMedic’s professionals have a very unique and in-depth understanding of the challenges of clinical trials and studies. 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.
We are a data driven company, generating high quality data – data and research is the core of every part of our operation. NiaMedic’s goal is to consistently improve and innovate its data, data collection, and analysis processes and support the research effort of our clients.
What Services Do We Offer?
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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
Types of Clinical Research
A clinical study involves research using human participants that is intended to add to medical knowledge. There are two main types of clinical studies - clinical trials (also called interventional studies) and observational studies.
Clinical trial – randomized controlled trial (RCT) - A study in which people are allocated at random to receive one of several clinical interventions. RCTs can demonstrate the superiority of a new treatment over an existing standard treatment or a placebo. In clinical research RCTs are used to answer patient-related questions, and in the development of new drugs they form the basis for regulatory authorities’ decisions on approval. RCTs are common to prove that a new therapy is better than all the previous ones. These studies can be done for a few dozen patients and for hundreds or even thousand of patients in multi-national trials. RCT is the gold standard in medical research for ascertaining the efficacy and safety of a treatment. Its results are valued the most by scientific journals and physicians. These studies are the hardest to conduct and require the highest amount of funds and approvals. All participants must sign informed consent and an institutional review board. (IRB) approval must be obtained prior to the trial initiation.
Clinical trial – single arm trials - Single-arm or non-randomized trials, in which everyone enrolled in a trial receives the experimental therapy, are common in the first phases of evaluation of a new drug. In these cases, researchers must use end points, like response rate, that can demonstrate clinical impact in the absence of direct comparison data. These studies are usually used for the initial evaluation of a clinical intervention and usually for a relatively small number of participants. All participants must sign an informed consent and an institutional review board (IRB) approval must be obtained prior to the trial initiation.
Clinical Study (retrospective) - A retrospective study looks backwards and examines exposure to suspected risk or protection factors in relation to an outcome that is established at the start of the study. Most sources of error due to confounding and bias are more common in retrospective studies than in prospective studies. For this reason, retrospective investigations are often criticized. These studies are purely observational and include evaluation of medical records for a desired outcome or risk factor. These studies usually do not require the approval of participants as the data is being pulled anonymously from the existing medical records. They do require an approval of an IRB before the exploration of the medical records. This type of study enables inclusion of a very high number of participants, even hundreds of thousands, but is usually more prone to different types of biases.
Clinical Study (prospective) - A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor(s). The study usually involves taking a group of subjects and watching them over a long period. All efforts should be made to avoid sources of bias such as the loss of individuals to follow up during the study. Prospective studies usually have fewer potential sources of bias and confounding factors than retrospective studies. These studies require an IRB approval and the informed consent of every participant. These studies differ from clinical trials because they do not include a new interventional therapy. They may include additional blood tests, urine tests, questionnaires, etc. that are not part of the common practice, but they will not include a new drug or a new indication for an existing drug.