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Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp

Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme

The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

Two most common anesthesia techniques used in the United States are intravenous and inhalation. Intravenous anesthetics or commonly known as IVAs are delivered to the lungs by means of the infusion pump, whereas inhalation anesthesia or commonly called inhalation anesthetics are inhaled directly into the nose. The inhalation method is less popular than the intravenous method mainly because of the difficulty in determining the exact drug concentration needed for effective anesthesia. Several studies and clinical trials have focused on determining the efficacy of both types of anesthesia techniques. For instance, in November 2020, a new clinical trial, The Volatile vs Total intravenous Anesthesia for major non-cardiac surgery (VITAL) trial was launched to compare two types of anesthetic to determine how soon after surgery they allow patients to return home. The trail will compare two methods of delivering anesthesia to a patient: inhalation and intravenous. The main functions of inhalation anesthesia are to relieve chest pain, provide relief to the airways in asthma and reduce the amount of sepsis (severe respiratory distress) in critically ill patients. The mechanism of action is quite similar to that of different drugs in the field of medication wherein it effects the different tissues in the body to produce a desired effect. It affects the muscles, ligaments and tissues in the airways by blocking the airway. Inhalation anesthetics are also referred to as antidepressants because it affects the brain chemical systems such as those responsible for depression and anxiety. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/clinical-trial-focuses-on-determining.html

Deep brain stimulation is a non-invasive neurosurgical treatment involving the placement of an electronic device called a simulator that emits electronic pulses, into the brain. These pulses are delivered to the area where there is the greatest need for stimulation, in the area known as the cerebral cortex. The purpose of this treatment is to increase brain function and improve brain function. This treatment is often used in conjunction with other procedures and is also very successful when it is used alone. Increasing prevalence of Parkinson's disease is expected to propel growth of the global deep brain stimulation devices market. For instance, according to the study, 'Prevalence of Parkinson's disease (PD) across North America", published in July 2018 in the journal Nature, the number of people suffering from PD is expected to reach 930,000 in 2020 and 1,238,000 in 2030. Increasing number of clinical trials for deep brain stimulation devices is expected to offer lucrative growth opportunities for players in the global deep brain stimulation devices market. For instance, in January 2021, Medtronic plc announced the first enrollment in ADAPT-PD, a trial evaluating the safety and efficacy of adaptive deep brain stimulation in patients with Parkinson's disease. Similarly, in October 2020, Keck Medicine of USC announced to enroll individuals in an international phase 3 clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer's. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/increasing-prevalence-of-parkinsons.html

MedRhythms, a US-based digital therapeutics company, has launched its five-site randomised controlled trial (RCT) at rehabilitation hospitals and research centres to examine a post-stroke walking rehabilitation device.

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity.

The global veterinary CRO market was valued at $577.20 million in 2020 and is projected to reach $1,175.72 million by 2030 registering a CAGR of 7.7% from 2021 to 2030. Contract research organizations (CROs) are companies that help assist in research & development and/or other services related to newer products for sponsor companies.

In order to become a safe and effective medicine, a compound has to travel through a lengthy process of rigorous testing. Over the last few decades, the amount of time required to develop and test a novel drug has increased drastically. However, the introduction of social media and digital technology into drug development have the ability to significantly expedite this process. This webinar will explore the policies and principles of using social media through the evolution of developing a pharmaceutical drug from its initial stages to its introduction into the market. This includes analyzing the methods in which pharmaceutical companies utilize social media during the planning process, identifying the best candidate for the lead compound in a drug, conducting animal and human testing, recruiting candidates for clinical trials.

Overview: Participants will understand the importance of responding to the OCR pre-audit requests and how to respond. Our discussion will cover how to prepare for an anticipated OCR HIPAA privacy audit, by discussing how to conduct an internal self-assessment of your privacy program. We will discuss how to conduct the self-assessment, whether it be the need for policies, procedures or obtaining all of your business associates information. Why should you Attend: If you have received a request from the OCR to provide the name of your entities privacy official and additional criteria, you are already aware that you are on the OCR's radar and may be the focus of an audit. If you haven't received a request yet, anticipate receiving one soon. In addition to ensuring that your HIPAA program is audit ready, you also need to ensure that you know all of your business associates and have their information readily available to provide to the OCR. Your entity needs to be ready now, as the OCR will either conduct focused desk audits, on-site audits or both in effort to review documentation of evidence of your compliance with the HIPAA regulation. Areas Covered in the Session: Office of Civil Rights "OCR" requests for privacy official and additional information and timeline for response Internal assessment criteria of privacy program in anticipation of an OCR audit Conducting the assessment using the template based upon HIPAA regulations Discuss methods to address any found deficiencies Workforce training Who Will Benefit: Healthcare providers Compliance and Internal Audit professionals or office staff responsible for ensuring patient privacy Healthcare Administrators Business Associates and all HIPAA Covered Entities Speaker Profile Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges

Overview: Participants will learn how to conduct an investigation of allegations of patient privacy violations using a privacy "risk analysis" tool and steps that should be taken when a breach has been determined. Why should you Attend: You must conduct a prompt and thorough investigation of all allegations of privacy violations. A violation of a patient's privacy may result in monetary penalties, harm to your reputation and especially harm to a patient. You need to make certain your organization has the expertise to conduct a thorough privacy investigation, analyze the results and take all necessary action to mitigate and report violations when required. Areas Covered in the Session: Best practices for conducting a privacy investigation Use of the risk analysis tool Interpretation of your results Reporting requirements if necessary Recommendations of continued privacy monitoring Workforce training Who Will Benefit: Healthcare providers Compliance and Internal Audit professionals or office staff responsible for ensuring patient privacy Healthcare Administrators Business Associates and all HIPAA Covered Entities Speaker Profile : Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges from starting new compliance programs and making improvements to existing programs for physician practices to large health care organizations. Gail also has provided numerous lectures to healthcare providers, executives and professional colleagues. Gail Madison Brown will develop, implement, and oversee processes, systems, educational programs, and other activities necessary to support and grow clinical trials activities at the UT Health Science Center. The Chief Clinical Trails Officer (CCTO) provides overall strategic leadership in this area including planning, goal setting, and monitoring organ

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu

Overview: Become knowledgeable and understand the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law, Excluded Individuals and additional criminal/civil laws that may worsen the punishment if these laws are violated. Understand the criteria of each law, exceptions and how to identify an issue that requires mitigation. Why should you Attend: Are you able to distinguish with certainty an agreement, contract or activity that is permissible versus one that is not under our current healthcare laws and regulations? Do you have a contract organization system where reviews are done regularly and retained centrally? Do you conduct auditing and monitoring of potential high risk compliance areas related to fraud, waste and abuse? If you are uncertain or need additional guidance on recognizing potential violations of healthcare fraud, waste and abuse regulations and how to audit and monitor for non-compliance, this training is for you. Areas Covered in the Session: Define and describe elements of the Anti-kickback Statute, False Claims Act, Exclusionary Rule, Physician Self-Referral Law and potential penalties for violations Discuss exceptions and related criteria to the Physician Self-Referral Law and the Anti-Kickback Statute Identify common potential issues that may result in violations and how to avoid or mitigate them Provide examples on how to comply with the regulations Describe areas to audit, monitor and implement policies/procedures for compliance Who Will Benefit: Health care providers Revenue cycle management employees Coders, Billers Compliance officers Contract management Compliance and Internal Audit professionals Healthcare administrators Speaker Profile Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges from starting new compliance programs and making impr

Graft-versus-host disease (GvHD) is a systemic disorder and a common complication after allogeneic hematopoietic stem cell transplant. The condition can be subclassified into acute classic GVHD, persistent, recurrent, or late-onset acute GVHD, classic chronic GVHD, and overlap syndrome. High adoption of hematopoietic stem cell transplantation and increasing prevalence of certain cancers of the blood or bone marrow, such as multiple myeloma or leukemia is expected to propel growth of the graft versus host disease (GvHD) market. For instance, according to Leukemia and Lymphoma Society, 176,200 people in the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2019. Moreover, around 30,000 patients undergo allogeneic hematopoietic stem cell transplant annually in the United States, with approximately 20% to 85% developing aGvHD that affects the skin, gut, or liver. Increasing number of clinical trials for graft versus host disease is expected to offer lucrative growth opportunities for players in the graft versus host disease (GvHD) market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/high-adoption-of-hematopoietic-stem.html

Medical transcription services are health reports that are typed out from dictated medical reports by medical professionals, such as doctors, dentists, and physicians. These reports contain vital information regarding a patient's health and are crucial to their care. This service offers data accuracy and data-driven insights for making an easy decision regarding patient treatment and care. Medical transcription services can be classified into Discharge Summary (DS), History and Physical Report (H&P), Operative Note or Report (OP), Consultation Report (CONSULTS), and Pathology Report (PATH) & Radiology Report. Continuous advancement in the medical transcription services market is expected to drive the growth. For instance, in October 2020, ETranscription, a Canadian transcription company, launched its new website and platform to expand its high-quality transcription services. The company has offered a free trial and reduced rates to help hospital streamline their workflow. Moreover, updates support a seamless online transcription process while delivering secure, accurate, and cost-effective services. This service effectively reduces clinical documentation time and enables doctors to plan the patient's treatments. Increasing adoption of technologies such as digital health, telemedicine, and EHR is further anticipated to foster the growth of the medical transcription services market in the near future. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/medical-transcription-services-has.html

Biosimilars, also known as biologic products, are currently the fastest growing category of medical products in the United States, with sales estimated at more than $40 billion dollars annually. When prescribed by doctors, these products may provide more effective treatment options for patients suffering from a chronic disease or condition. In late August, the FDA held a forum on biosimilars. The topic was "biosimilar medications - what are they, how do they work, and are they safe and effective." Representatives from the FDA, pharmaceutical companies, and biotechnology organizations attended the forum. The forum included individuals who are leading the charge to register biosimilar products for clinical trials. According to the FDA, the agency will begin accepting applications for biologic drugs in late fall of 2020. In Japan, various manufacturers are focused on developing pipelines that contain biosimilar candidates aimed at treating various therapeutic conditions for patients in Japan. For instance, in December 2020, Alvotech and Japanese pharmaceutical company Fuji Pharma agreed on an extension on their exclusive strategic partnership for the commercialization of four biosimilar medicines in Japan. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/biosimilars-and-impact-of-covid-19.html

eClinical solutions are used to improve the clinical development process through data analysis and management. It offers clinical and operational data by providing data management software and customized data management services, including clinical reporting, electronic data capture, data management and standardization, and clinical data repository platform, with total transparency. eClinical solutions allow users to standardize, integrate, manage, and analyze all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. Moreover, eClinical software help users to comply with budgeting, investigator management, patient management, government regulations, and adverse event reporting system among others. eClinical solutions integrate electronic health records, eTechnologies, electronic consent forms, clinical data management systems, and electronic data capture. Moreover, they are helping researchers in lengthy clinical research processes through proper management. eClinical solutions have gathered substantial market proposition among pharmaceutical and biopharmaceutical companies for streamlining their clinical trials and insights discovery across various phases from I to IV. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/eclinical-solutions-help-reduce-human.html

Immunoassays, or DNA assays, are a method of DNA analysis. DNA is the basis of all biological material, including the DNA of living organisms, cells, and tissues. This method can be used to analyze, identify, and profile various biological samples. The analysis of DNA has developed greatly over the years, due to the ability to conduct DNA tests on living people. The use of immunoassays for gene-based analysis has grown tremendously. Primarily, immunoassay analysis is used to evaluate gene-based treatments in oncology, cardiovascular, orthopedics, infectious diseases, and clinical diagnostics. Currently, the primary uses of immunoassays are for the evaluation of gene-based therapies in oncology and cardiovascular clinical trials. The analysis and measurement of immune parameters by immunoassay instruments are known as response curve analysis (RCA). The first analysis of RCA was done by Ward and coworkers in 1980, using monoclonal antibodies to stimulate the lymphocytes Subsequent immunoassay measurement models and systems have been developed to extend the scope of research and to make immunoassay measurement more cost-effective. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/immunoassay-instrument-is-gaining-rapid.html