Clinical Operations-Design to Execution

BayBiotech.NET A quality management system (QMS) is a collective term for a management framework comprising of policies, plans, practices, and the supporting infrastructure by which an organization aims to reduce, eliminate and maintain non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. Quality management systems are relevant especially for healthcare/ Biotech/Pharmaceutical industry that are regulated by FDA. All organizations whether large or small, public or private, manufacturing or service oriented are benefited by implementing a quality management system. Although a small company may have an in-house developed QMS system to manage the compliance and meet the production specifications for internal as well as external regulatory requirements, eventually it becomes difficult to manage the same in larger companies or multinationals. As it is obvious that for best results QMS must be implemented globally in an or...

BayBiotech.NET A 510k is a premarket submission made to FDA to demonstrate that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. A Traditional 510(k) submission must include the required elements as per 21 CFR 807.87 (Information required in a premarket notification submission):  the name of device, (the trade or proprietary name), if any, and the common or usual name or classification name of the device.  description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable.  comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operatio...

BayBiotech.NET As per definition of National Technology Initiative, nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers. Encompassing nanoscale science, engineering, and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. According to NTIG at this scale unusual physical, chemical, and biological properties can emerge in materials and the properties may differ in important ways from the properties of bulk materials and single atoms or molecules. Recognizing a great potential for this technology for drug delivery/ device in medicine, in July 2007 FDA issued a press release outlining the regulatory challenges that the implementation of the technology will have for the agency and geared up towards developing guidance as well as regulations to address the benefits and risks of drugs and devices using nanotechnology. As it is obvious, development and Implementation of...

BayBiotech.NET Office for Human Research Protections (U.S. Department of Health and Human Services) has compiled a list of 1,100 laws, regulations, and guidelines governing human subject’s research in 92 countries, as well as standards from a number of international and regional organizations. This 85 pages list has been developed for IRBs/Ethics Committees, researchers, sponsors, and others who are involved in international research with a purpose to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure those standards are followed appropriately. The 2009 Edition is the latest updated version that includes numerous additions and updates to the 2008 Edition, and further includes the laws, regulations, and/or guidelines for 7 new countries: Burma (also known as Myanmar), Egypt, the Gambia, San Marino, South Korea, the Sudan, and Vietnam. If you are clinical research personnel and would like to get the l...

BayBiotech.NET Recent FDA Amendments Act of 2007 has emphasized needs of active adverse event surveillance methods linking multiple sources of clinical data for analysis and further mandates creation of effective tools for post market risk identification, assessment and management of adverse events. Legislation recognizes the limitations of traditional mainstream drug safety practices in the pharmaceutical industry that depends on the collection and analysis of safety data from clinical trials and therefore emphasizes the need of data mining from multiple sources. In past few years, emerging need of data mining has generated lot of interest among various competitors to develop tools within the limits of privacy and confidentiality limits to meet the drug safety needs. FDA is in the process of currently exploring, testing, and developing new methods of signal detection, data mining, and analysis of patient-level electronic healthcare data hoping that these new developed methods will...

BayBiotech.NET Following is a summary of the key points on the laws, regulations and Good Clinical Practices of the Member States as per European Union’s Directive for conduct of Clinical Trials on human subjects: 1. Directive requires that applications for authorization to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. A dossier must be prepared in compliance with uniform rules laid down by the Member States. 2. A detailed risk assessment and management strategy must be in place based on the toxicological data derived at Pre-clinical research stage. 3. Persons who are incapable of giving legal consent such as dementia, psychiatric patients etc. to clinical trials should be given special protection. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. These...

BayBiotech.NET Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) required the Department of Health and Human Services (HHS) to establish national standards for the security of electronic health care information. Department of Health and Human Services prepared certain guidelines that specify a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality of electronic protected health information (EPHI). This is particularly relevant for organizations that allow remote access to EPHI through portable devices or on external systems or hardware not owned or managed by the covered entity. Guidelines address mainly the privacy of health information issues that may arise by using laptops; home-based personal computers; PDAs and Smart Phones; hotel, library or other public workstations and Wireless Access Points (WAPs); USB Flash Drives and Memory Cards; floppy disks; CDs; DVDs; backup media; E...