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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

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

Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use

Overview: The presentation takes the participant through the steps needed to ensure a successful health care computer system implementation. Once presented the participant will see the logic of the tools and processes and be able to apply them to their system implementation. The tools and processes presented in this material have been developed by implementing health care systems for over 40 years and seeing what has worked and WHY it has worked. These tools and processes have been equally and successfully applied to the implementation of large, complex systems and smaller, simpler systems for large, multidepartment organizations and for small health care organizations. The process focuses on establishing the project's implementation expectations, identifying meaningful metrics for success, establishing project plans, assigning individual accountabilities and responsibilities, establishing and executing project tasks, monitoring project progress and validating project success. To establish viable project expectations, the presentation addresses the need for bringing all of the stakeholders (organization owners, providers and management, operations staff, IT staff and the vendor) into establishing common and realizable expectations. These are reviewed in context of the organization's current environment and its short and long term goals and are considered as a critical part of the implementation completion process. In the case of turning around an already troubled or failed system implementation, the process emphasizes the tasks of reassessing the project stakeholder expectations - why they decided the system would help the organization and what they expected to get from the system. Next the process shows the participant how to convert these expectations to realistic and measurable project success metrics. The process focuses on learning how to separate "so what" metrics from meaningful and measurable metrics. In addition, the process provides direction regardin

Protein A colorimetric resins are the most extensively used affinity purifiers in bio-manufacturing and other industries. Protein A colorimetry is a robust, high-throughput chromatography method and is used primarily as a capture step because of its inherent precision. Approval and launch of new biosimilars is expected to propel growth of the protein A resin market. For instance, in December 2020, Sandoz Canada Inc., a generics and biosimilars manufacturer and a division of the Switzerland-based multinational Novartis AG, received Health Canada authorization for Hyrimoz (adalimumab injection, reference biologic drug: Humira) on November 4, 2020 for marketing in Canada. Hyrimoz, the new biosimilar, has been approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis. Moreover, high prevalence of chronic diseases is also expected to aid in growth of the protein A resin market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/emergence-of-covid-19-to-offer_23.html

Healthcare document automation involves the rescue and provides you the platform needed to get patients' records with ease and speed. the very fact that medical records may are available different formats, therefore the software you depend upon should have the power to capture, convert, then migrate the knowledge to the system where the knowledge are going to be used for generating different documents needed.

InstaPay Healthcare Services is a reliable provider of medical billing and coding services that can help healthcare providers focus on patient care while leaving billing and coding to the experts.

InstaPay Healthcare Services is a leading medical billing and coding service provider in New York. We specialize in charge capturing, claim submission, and denial management services. Our team of experienced healthcare providers ensures timely and accurate account receivable management.

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje