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The PMS process is focused on the collection and analysis of the data that comes from various sources and is carried out according to a PMS plan to be established for each MD in order to:

Health & Medicine

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PMS Process and Risk
Management Plan: what is it?

The PMS process is focused on the collection and analysis
of the data that comes from the various sources and is
carried out according to a PMS plan to be established for
each MD in order to:

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Update the benefit-risk determination and
improve the risk management;
Update the design and manufacturing
information, the instructions for use and
the labelling;
Update the clinical evaluation;
Update the summary of safety and clinical
performance;
PMS Plan For Each MD

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Identify the needs for preventive, corrective
or field safety corrective action;
Identify options to improve the usability,
performance and safety of the device;
Contribute to the post-market surveillance of
other devices;
Detection and reporting of trends.
Risk management requirements for post-
market surveillance for medical devices.

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With PMS becoming a duty for medical device
manufacturers, the effective risk management system
becomes a priority as well as one of the three basic
elements that ensure compliance and safety, alongside with
PMS and clinical evaluation

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Risk Management Plan

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According to the MDR, manufacturers are expected to provide
evidence of a risk management plan created for the whole
lifecycle of products. Such plans should be used for tracking
and reducing any potential hazards and ensuring the safety
of the devices.

ProRelix Research
is here for the
timely execution
of your projects!
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The United States has always been and remains to be the leading place for the conduct of clinical trials. According to Clinicaltrials.gov, the largest clinical trials registry, 32% of registered clinical trials were conducted in the U.S. as of May 2022 (1). Factors such as the availability of qualified healthcare professionals, high-quality infrastructure and facilities, cutting-edge research, an efficient regulatory system, and a high standard of ethics and participant protection make the U.S. the leading country for clinical trials. Clinical trials follow extensive preclinical research to test the safety and efficacy of a new drug, medical device, or biological in humans. They are usually divided into three phases: phases I, II, and III which are designed to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse events. Figure 1 shows the typical route from discovery and preclinical studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing drugs to the market and have the highest attrition rate, only 10% of drugs that enter phase I trials are granted marketing approval. Therefore, clinical trials should be conducted by experts that are well-versed with all the regulations and guidelines in a particular region to boost the chances of drug approval. The United States Food and Drug Administration (US FDA) is the regulatory body that approves and oversees the conduct of clinical trials for drugs, medical devices, and biologicals that are intended to be marketed in the U.S and is touted to have the most stringent standards for drug approval. The primary role of the FDA is to protect public health by ensuring that medicinal products and devices are safe and efficacious. Therefore, it is necessary for sponsors/investigators or contract research organizations (CRO) that are conducting clinical trials to be familiar with regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the regulations and guidelines set by the FDA. It is important to know what is needed for a successful clinical trial, from selecting an appropriate study site to obtaining informed consent from participants. Additionally, it is essential to understand the requirements for data collection and analysis, as well as how to develop an effective protocol. Clinical trial services in USA can provide guidance on all of these aspects and more, helping you ensure that your clinical trial meets all necessary standards

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The first image that comes to mind when one thinks of where safety and efficacy data for a new treatment is generated is a randomized controlled trial (RCT) at a central site. Although RCTs remain the gold standard for evidence generation of new treatments, they are limited in terms of their applicability to broader patient populations with different demographics such as age, ethnicity, and comorbidities thus limiting their generalizability. RCTs are carried out under strict conditions and dosing schedules which are often not observed in the real world and are conducted for limited time periods which are usually not sufficient to capture adverse events, especially in the case of chronic diseases. This has led to a shift in the thinking of sponsors, drug developers, payers, and regulators to consider the use of real-world data and real-world-evidence studies to inform decisions related to the product as well as to support reimbursement decisions.Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medicinal product obtained from real-world data (RWD). RWD is regarded as observational data that is collected outside of a traditional RCT (1). Although the terms RWD and RWE are used interchangeably they are two distinct concepts. Not all RWD translates into RWE. RWE is obtained by detailed analyses of data from different types of trials such as pragmatic trials, observational studies which can be prospective or retrospective, late-phase trials, or hybrid trials which are designed to collect data from patients in a real-world setting. The data that is collected can be in various forms such as electronic health records (EHRS), claims and billing data, product and disease registries, prescription data, data collected from routine hospital and physician visits, patient-reported outcomes (PROs), and mobile and wearable devices. Recently, data from biobanks and ‘-omics’ data is becoming a valuable source of RWD. RWE studies are intended to complement data generated from RCTs by providing a detailed view of the actual use of the product and effectiveness and safety data that RCTs are unable to capture.There has been a recent upward trend in the number of RWE trials conducted. In 2021, the Global Data Clinical Trials Database recorded 194 RWE trials and the Food and Drug Administration (FDA) published 90 examples of the use of RWE to support regulatory decisions (2). Since 2018, the FDA has released several pieces of guidance to support the use of RWD and RWE for regulatory decision-making for drugs and medical devices and the type of data to be submitted to support these applications. The two main drivers for recent interest and uptake of RWE studies are:

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Clinical trials in oncology are vital for the advancement of cancer treatments and care. The US is at the forefront of these clinical trials, with many different study designs being used to assess the efficacy and safety of new treatments. This article will explore the current state of oncology clinical trial services in the US, as well as discuss different types of study designs that are commonly used. It will provide insight into how these trials are conducted, what data is collected, and how this information can be used to improve patient care. The United States Food and Drug Administration (FDA) has released several guidance documents over the years through the Oncology Center of Excellence to support the development of oncologic treatments and diagnoses. Furthermore, information on the clinical trials for the treatment of different types of cancer or specific interventions can be found on the National Cancer Institute (NCI) website and Clinical Trials. Currently, ClinicalTrials.gov, a website maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH) contains listings of publicly and privately sponsored trials and includes information on 91,937 studies related to cancer indicating the high volume of research being conducted in this field.According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). Aside from the high mortality rate and morbidity associated with cancer, it also negatively impacts the quality of life and poses a significant financial burden on patients and payers making it imperative to develop effective treatments for the disease. According to Global Cancer Observatory (GLOBACAN), the United States accounted for 13.3% of all estimated new cases of cancer in 2020 (2). In 2020, the single leading type of cancer in the United States was breast cancer (11.1%) followed by lung cancer (10%), prostrate (9,2%), colorectum (6.8%), and melanoma of the skin (4.2%). Despite the significant prevalence of cancer and numerous clinical trials conducted for oncology treatments, data have shown an almost 95% attrition rate for anticancer drugs from Phase I trials until marketing authorization. Various factors such as inaccurate preclinical models, lack of suitable biomarkers in clinical trials, and a disconnect between industry, academia, and regulators are responsible for the high attrition rate (3). Therefore, it is vital to develop suitable study designs and protocols for candidate molecules such that they obtain regulatory approval and can be marketed. In addition to these challenges, the development of anti-cancer agents comes at a monumental cost of an estimated $2.8 billion. Several factors such as the choice of relevant endpoints, the choice of appropriate biomarkers that are guided by tumor biology, and careful patient selection are expected to improve the overall fate of oncologic agents in the clinical trial phase

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1. www.prorelixresearch.com PMS Process and Risk Management Plan: what is it?

2. The PMS process is focused on the collection and analysis of the data that comes from the various sources and is carried out according to a PMS plan to be established for each MD in order to: www.prorelixresearch.com

3. www.prorelixresearch.com Update the benefit-risk determination and improve the risk management; Update the design and manufacturing information, the instructions for use and the labelling; Update the clinical evaluation; Update the summary of safety and clinical performance; PMS Plan For Each MD

4. www.prorelixresearch.com Identify the needs for preventive, corrective or field safety corrective action; Identify options to improve the usability, performance and safety of the device; Contribute to the post-market surveillance of other devices; Detection and reporting of trends. Risk management requirements for post- market surveillance for medical devices.

5. www.prorelixresearch.com With PMS becoming a duty for medical device manufacturers, the effective risk management system becomes a priority as well as one of the three basic elements that ensure compliance and safety, alongside with PMS and clinical evaluation

6. www.prorelixresearch.com Risk Management Plan

7. www.prorelixresearch.com According to the MDR, manufacturers are expected to provide evidence of a risk management plan created for the whole lifecycle of products. Such plans should be used for tracking and reducing any potential hazards and ensuring the safety of the devices.

8. ProRelix Research is here for the timely execution of your projects! www.prorelixresearch.com

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