Clinical Operations-Design to Execution

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...

BayBiotech.NET The European Commission’s Directive on Data Protection w.e.f.October of 1998 prohibits the transfer of personal data to non-European Union nations that do not meet the European “adequacy” standard for privacy protection of the personal data. For purposes of the policy, "personal information" means information that:  is transferred from the European Union to the United States;  is recorded in any form;  is about, or pertains to, a specific individual or can be linked to that individual. While both the United States and the European Union share the goal of enhancing privacy protection for their citizens, the United States takes a different approach to privacy from that taken by the European Union. With a goal to bridge the different privacy approaches between the United States and European Union and provide a streamlined means for U.S. organizations to comply with the Directive, the U.S. Department of Commerce in consultation with the European Commissi...

BayBiotech.NET FDA launched its Critical Path Initiative (CPI) in March 2004, with the release of a report “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”. This report highlights the reasons for the widening gap between modern scientific discoveries with a potential to prevent and cure some of today's biggest medical challenges, and their translation into innovative medical treatments. The main reason identified was being Industry’s apprehension to adapt and train to new technologies that might delay launch of the product into the consumer market. In order to ease out the apprehension, FDA recognized the need for a collective action to modernize the scientific and technical tools and introduced CPI and calls for incorporating specific activities into the medical development path that would help modernize the critical path sciences. CPI has seen the number of its projects grow from 40 in 2006 to 95 in 2009. FDA is collaborating wi...