Contract Research Organization for Medical Devices & Services
Contract Research Organization for Medical Devices & Services
We are the Contract Research Organization for Medical Devices & Services, a global consultancy that creates evidence to support Start-ups, SMEs and Fortune 500 Companies in the implementation of Medical Devices, In Vitro Diagnostics, and Digital Health Solutions into healthcare systems around the globe.
Systematic Reviews (SRs) are a type of literature review that uses systematic methods to collect secondary data, critically appraise research studies, and synthesize findings qualitatively or quantitatively.
Early Health Technology Assessment (HTA) is often a pre-clinical, pre-market access assessment of the cost and benefit of new medical intervention. It can be used to assist go/no-go decision in product development, pricing strategies through headroom analyses or to help design the best upcoming clinical trial.
Human Factors (HF) research is the application of psychological and physiological principles to the engineering and design of products, processes, and systems. The goal of human factors is to reduce human error, increase productivity, and enhance safety and comfort with a specific focus on the interaction between the human and the medical device.
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new devices and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy.
A Pragmatic Clinical Trial (PCT) is a clinical trial that focuses on correlation between treatments and outcomes in real-world health system practice rather than focusing on proving causative explanations for outcomes, which requires extensive deconfounding with inclusion and exclusion criteria so strict that they risk rendering the trial results irrelevant to much of real-world practice
Real World Evidence (RWE) in medicine means evidence obtained from real world data, which are observational data obtained outside the context of randomized controlled trials and generated during routine clinical practice. In order to assess patient outcomes and to ensure that patients get treatment that is right for them, real world data needs to be utilized.
Data analysis is a process of inspecting, cleansing, transforming, and modeling data with the goal of discovering useful information, informing conclusions, and supporting decision-making.
Biostatistics are the development and application of statistical methods to a wide range of topics in medicine. It encompasses the design of experiments; the collection, summarization, and analysis of data from those experiments; and the interpretation of, and inference from, the results.
Machine learning is the scientific study of algorithms and statistical models that computer systems use to effectively perform a specific task without using explicit instructions, relying on patterns and inference instead. It is seen as a subset of Artificial Intelligence (AI).
Cost-effectiveness Analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of different courses of action. Cost-effectiveness analysis is distinct from cost–benefit analysis, which assigns a monetary value to the measure of effect. The most commonly used outcome measure is quality-adjusted life years (QALY).
Budget Impact Analysis (BIA) is used to estimate the likely change in expenditure to a specific budget holder resulting from a decision to reimburse a new healthcare intervention (or some other change in policy) at an aggregate population level. The budget (or financial) impact is usually calculated using a budget impact model, over a period of 3 to 5 years, at a national level or for more local healthcare payers and providers.
Value of Information (VOI) analysis is a means of valuing the expected gain from reducing decision uncertainty through some form of data collection exercise (e.g., a trial or epidemiological study). As such, it is a tool which can be used to assess the cost effectiveness of alternative research projects.
Regulatory Affairs (RA) have responsibility for ensuring that your project complies with all of the regulations and laws pertaining to medical devices & services in a chosen jurisdiction. Quality Affairs (QA) include, but are not limited to, audits of your Quality Management System (QMS), review of corrective actions, complaint handling, internal auditor training, etc.
Pricing and reimbursement broadly refers to establishing a price and obtaining a positive reimbursement decision, or listing status, for your medical device or service.
A regulatory submission for a medical device includes any documentation or information submitted to a regulatory agency for review, for notification, or in response to a request for additional information. A Value Dossier presents a summary of the clinical, economic, and humanistic value and supporting evidence (studies) for a new medical device in a disease area as well as background information on that disease (i.e., burden of illness, epidemiology, etc.)
Postmarketing Surveillance (PMS) is the practice of monitoring the safety of a medical device or service after it has been released on the market. Postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
Post-Market Clinical Follow-up (PMCF) is active collection of data on clinical experience with a medical device after market release. These activities can range from analysis of data from existing device registrations to performing a new clinical investigation.
Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles.
A medical device can be an instrument, apparatus, appliance, software, implant, reagent, material or other articles. From syringes and wheelchairs to cardiac pacemakers and medical imaging technologies (such as MRI, CT and X-ray machines), medical devices can play a range of roles in maintaining and restoring health.
In vitro diagnostics (IVDs) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.
Digital health and care refers to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle. Digital health has the potential to innovate and improve access to care, quality of care, and to increase the overall efficiency of the health sector.
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Contract Research Organization for Medical Devices & Services (CROMDS) is a global MedTech CRO that creates evidence for the implementation of medical devices, in vitro diagnostics, and digital health solutions into global healthcare systems.
We have regional offices in five cities: London, Boston, Amsterdam, Geneva, and Hong Kong. Contact our local office here.
167 Great Portland Street, Westminster, London, W1W 5PF, United Kingdom
Companies House Number: 11857634
Monday - Friday: 9:00am - 6:00pm
Saturday - Sunday: Closed
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