Creating a presentation report based on data validation,first date ideas orlando,how to make html5 presentation example - For Begninners

New medicines are constantly being developed through a series of controlled trials which assess the safety and efficacy of each new medicine by applying high scientific standards.
In Phase 1, an experimental medicine, also called an "investigational new drug," is administered for the first time to humans. In Phase 2, the focus of the trials is on the effectiveness of an experimental medicine in treating an illness or medical condition. Phase 3 trials test the results of earlier trials in larger populations and gather additional information about the effectiveness and safety of an experimental medicine.
The next step in bringing a new medicine to market is the filing of an application with the health regulatory authority of a country in order to obtain approval to market the new medicine. Defined by the FDA as a "strategy to manage a known or potential serious risk associated with a drug or biological product," a risk evaluation and mitigation strategies (REMS) may be required as part of an NDA, abbreviated new drug application (ANDA), or biologics license application (BLA) when the agency deems it necessary to take additional steps to ensure the product's benefits outweigh its risks. A description of the medicine's manufacturing process along with quality data and trial results need to be provided to the health regulatory authorities to demonstrate the safety and effectiveness of the new medicine. A major goal of biostatisticians and clinical data managers throughout the pharmaceutical industry is to implement consistent internal processes to maintain, manage, and monitor data in a manner compliant with regulatory agencies' requirements throughout the drug development lifecycle and beyond. Simultaneously, teams of medical writers and programmers must produce accurate and consistent statistical tables and listings to present this data and their findings.
With the Clinical Data Interchange Standards Consortium (CDISC) setting out additional standards-the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) -to support the derivation and calculation of the data, as well as recent emphasis on post marketing safety in the form REMS,  the situation becomes even more daunting. These trials, also called "post-marketing studies," are conducted after the regulatory approval of a medicine.
Recently, as part of the United States' regulatory approval process for new medicines, new uses for existing medicines, and the continuous monitoring of safety, companies may be required to conduct additional studies and testing to support the safety and effectiveness of their medicines. The creation of REMS as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) marked a significant moment in the regulation of drugs and biological products. Just because a drug has been on the market for a decade or two, does not exempt it from surveillance by the FDA.
FDAAA gives the FDA the discretion to require the sponsor to make any changes to the label the agency "deems appropriate to address the new safety information." Moreover, FDAAA confers authority to the FDA to level civil, monetary penalties if these post-approval studies are not conducted to the agency's satisfaction or are delayed. In essence, the process requires the FDA to use electronic medical records as the primary source of data to track all aspects of product safety (and probably efficacy as well). Fortunately, by adhering to, and properly managing, data standards, intelligently organizing and presenting clinical data and post-marketing surveillance data among workgroups, departments, and across an enterprise to the FDA, organizations can dramatically improve time- and cost-savings, increase productivity, provide earlier visibility to reliable clinical data, and most importantly avoid disastrous product recalls. For almost anyone involved in the life sciences industry over the past two decades, the widespread use of SAS® as the de facto standard for producing safety and efficacy data analyses, transforming and transporting data in clinical trials, and FDA submissions is well-recognized.
Generating tables and listings that intelligently and elegantly present these statistics and data can be a costly and extremely time-consuming undertaking, especially considering the salary of an advanced SAS® programmer. The ClinPlus Report System can also produce many more summary statistics and inferential tests than PROC Report, in presentation quality, and in a more flexible way. Datawatch Dashboards™ is a fully interactive dashboard solution that gives all levels of healthcare providers, and their end-users, a visual overview of financial, clinical and operational performance. The intuitive user interface based on Flash® technology delivers a vivid presentation of critical business data by monitoring, measuring and managing key performance indicators (KPIs). Unlike traditional BI solutions, Datawatch BI solutions are unique in that they can be implemented in days versus months, and can help to rapidly achieve a positive ROI, a lower total cost of ownership, and provide immediate, actionable insight into critical business data—without programming or any changes to existing systems. No matter the size or scope of the analytic or information delivery needs, Datawatch BI solutions can help quickly access and analyze data, smarter and more cost effectively than ever thought possible!


Drug Information: Question about drugs such as dosage, indications, contraindications, side effects, interactions and ingredients.
Environmental: Questions involving contamination of air, water or soil including disposal of chemicals, potential danger of treatments by lawn care or exterminators. Poison: Questions regarding drug and substance abuse, unconsummated food that may be spoiled or contaminated, safe food handling, mutagenicity, carcinogenicity, or toxicity of a substance. Prevention: Questions regarding product safety, poison prevention, requests for literature.
Other: Requests for lectures or media interviews, checking accuracy of the poison center telephone number or any other pertinent questions not included above. Substance Abuse: Questions about drug screens, effects of illicit drugs (no known patient) new trends, or withdrawal from illicit drugs (no known patient). Caller Referred:Category used by centers for calls immediately referred to another information resource without providing any information.
To ensure such trials are conducted ethically, extensive rules and standards govern the trial design, investigator qualifications and training, external reviews by an institutional review board (IRB) or ethics committee, ongoing monitoring of all of the trial sites, and the obtainment of informed consent after the presentation of the risks and potential benefits of participation to the potential trial participant.
Phase 1 clinical trials usually focus on safety and tolerability, rather than the effectiveness of a new medicine.
Information about the experimental medicine's safety, side effects, and potential risks is also collected.
This phase usually involves several hundred to several thousand participants from multiple sites with many physician-investigators.
The FDA can also require holders of approved applications to submit proposed REMS based on newly introduced safety information, such as previously unrecognized or unlabeled risks or new findings concerning a known serious adverse drug reaction. Because they operate in a highly demanding and ever-changing environment, they must accomplish these goals while struggling with increasingly ambiguous regulations. Through such trials, researchers collect additional information about long-term risks, benefits, and optimal use.
In the European Union (EU) companies can be required to conduct additional studies and testing to support the safety and effectiveness of their medicines or to carry out other defined activities at anytime in the lifecycle of a product. FDAAA gives the FDA broad powers to control drug marketing and labeling, to require post-approval studies, to establish active surveillance systems, and to make clinical trial operations and results more visible to the public. Before requiring a post-market study, FDA must determine that adverse event reporting and post-market risk identification systems are insufficient to evaluate whether the drug can be distributed and taken safely. A one-size-fits-all approach to study design, particularly in light of developments in personalized medicine, may leave vulnerable patient populations underrepresented and conceal opportunities to mitigate risk. Not quite as many however, are familiar with the SAS® report generator, "PROC Report," which is often mistakenly compared to the ClinPlus Report system. ClinPlus Report streamlines the entire process by enabling a broad range of users-often working in disparate locations around the world-to produce identically formatted tables and listings of the data with limited SAS® programming knowledge. Because of its ability to support the need to present validated data for risk evaluation and risk mitigations, ClinPlus Report is being used by most of the top 10 pharmaceutical organizations worldwide to support their need to gain early visibility to clinical trial data, prepare regulatory submission content, and support post-marketing epidemiologic initiatives. Utilizing clinical and financial information from existing reports, databases and other sources of data, Datawatch Dashboards allows users to visualize data in a variety of eye-catching graphical chart types.
Whether the focus is on Meaningful Use Metrics, Financial Reporting or measuring operational performance, Datawatch Dashboards is an invaluable tool that puts users on the fast track to identifying trends, revealing issues, assessing results and making timely, informed decisions to rapidly initiate appropriate actions.
Low doses of the experimental medicine are administered to a small number of participants under the close supervision of an investigator.


These trials are often randomized and "double-blinded." "Double blinded" means that during the trial, neither the investigator nor the participant know who in the trial is receiving the experimental medicine versus a placebo (sugar pill) or another medicine (a "comparator"). These studies, testing and other activities are referred to as post-marketing commitments (PMCs). In short, REMS is the process by which the FDA is going to require the establishment of effective post-marketing surveillance of all adverse events, drug-drug interactions, side-effects, and so forth-and there is no restriction on the range of products the FDA can address with this authority. When these situations apply, the FDA requires sponsors submit a timetable for conducting the study, to provide periodic reports on the status of the study, including the number of participants enrolled, and the expected completion date. Accounting for biological differences between men and women or the special needs of patients with rare disorders where treatment options are limited, is critical to research and the development of treatment options. SAS® PROC Report procedures only offer summary statistics based on Proc Means and Proc Univariate, and multi-dimensional tables based on Proc Freq. It provides true authoring flexibility for any variety of statistical-based safety and efficacy tables and listings.
Trial participants are typically healthy individuals, although for some medicines, the first trials in human participants are patients with the disease the experimental medicine intends to treat. Typically, Phase 2 clinical trials involve up to several hundred participants (although in some cases there could be fewer than 100). Phase 3 trials generally provide the primary basis for the benefit-risk assessment for the new medicine and much of the core information about the medicine being analyzed for inclusion that will be described in the labeling of the medicine.
This approach avoids increased costs and the need for additional resources to conduct populations'-relevant, post-marketing studies. The FDA will use EMRs to assess product safety post-marketing; they are also going to be using EMRs to assess outcomes-and both safety and outcomes are going to be compared with pre-approval data as well as comparing drugs against each other in ways no clinical trial ever could. This SAS®-based report authoring tool can create simple data listings as well as complex statistical summary tables. Dosage of the new medicine is gradually increased during Phase 1 clinical trials to allow investigators to measure the participant's clinical response to the medicine, whether the medicine is sufficiently absorbed, how long the medicine remains in the bloodstream after dosing, and which dosage levels are safe and well-tolerated. The participants studied in Phase 2 clinical trials are usually patients who have the medical condition that the experimental medicine is intended to treat. In Europe, a Market Authorization Application (MAA) is filed with the European Medicines Agency (EMA) for the evaluation of medicinal products. The evolution of REMS thus far raises a question of how broadly the FDA intends to require REMS and what these plans must include. There is no doubt drug safety labels will be modified as a result of these activities and the pharmaceutical industry will be required to support, and subsidize, these new activities.
They are usually identified by physicians at research centers, clinics, and hospitals around the world.
Unlike other systems that simply generate stock reports, this powerful system empowers users with complete control over the "look and feel" of their templates, tables, and listings, and produces the highest quality output available in the industry.



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