Data Management and Statistics Clinical data management is the process of collection, cleaning, integration and management of subject data in compliance with regulatory standards. It is a critical phase in #clinicalresearch, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials, this has been facilitated by the use of software applications that maintain an audit trail..
Clinical Trials Supply Management The conduct of clinical trials is one of the most expensive aspects of the development of new #medicinalproducts. It is important, therefore, that the studies should produce high-quality data in the shortest possible time. More companies are trying to use single, larger, complicated trials in an attempt to gain the greatest amount of information about a product and thus reduce the lead time to market. A key element in ensuring this goal is the close…
Pharmacovigilance and Drug Safety The pharmacovigilance is related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products, and it is needed in different stages of product life cycle, and the #safetysurveillance and risk management.
Post-marketing Surveillance Post-marketing surveillance is the practice of monitoring the safety of a #pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of #pharmacovigilance. Post-marketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health…
Preclinical Research Preclinical research also named and nonclinical studies is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and data is collected.
Conducts of Clinical Trials Clinical trials also known as clinical research studies that follow a pre-defined plan or protocol. Researchers #designclinicaltrials (Clinical study designs) to answer specific research questions related to a medical product.
Future of Clinical Trials The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data.
Clinical Research on AIDS / Cancer / Diabetes HIV clinical trials are research studies done to look at new ways to prevent, detect, or treat HIV. Clinical trials are the safest and fastest way to determine if new medical approaches to HIV prevention or treatment are safe and effective in people.
Globalization of Clinical Trials The globalization of clinical research is a relatively recent phenomenon, in which many of these studies are taking place on a global scale, with a significant increase of clinical trials in developing countries.
CRO/ Sponsorship Clinical Trials CRO (Contract Research Organization) is an organization that provides support to the pharmaceutical, biotechnology, and #medicaldeviceindustries in the form of research services outsourced on a contract basis. Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.
Outsourcing in Clinical Trials Outsourcing of #clinicaltrials presents the US Food and Drug Administration (FDA) and companies with new issues around quality and responsibilities. By properly transferring responsibilities to contract research organizations (CRO) sponsors can eliminate some potential problems. As sponsor has to indicate what specific responsibilities they are transferring to the #CRO in writing.
Business Development in Clinical Trials When a clinical trial team registers their clinical trial on CT.gov, they will upload specific data about their operations to the site. Teams often share contact information, how many subjects they plan on recruiting, where the sites they'll use for recruiting are, and any sponsors involved with the trials.
Bioethics, Quality Regulation Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in medicine. It is also moral discernment as it relates to medical policy, practice, and research. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, #clinicalresearch, and philosophy etc.
Regulatory Considerations in Clinical #Clinicaltrials in humans are research studies designed to evaluate two or more treatments in human participants. Major concerns in any clinical trial are the protection of study participants’ safety and rights and ensuring the accuracy and validity of the data being collected. To ensure that these concerns are adequately addressed in a study, the funding institutions, the institutions where the research actually takes place, and federal and state…