Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
Health informatics is the study and implementation of computer structures and algorithms to improve communication, understanding, and management of medical information. It can be viewed as branch of engineering and applied science.
Proof of concept, also known as proof of principle, is a realization of a certain idea, method or principle in order to demonstrate its feasibility, or viability, or a demonstration in principle with the aim of verifying that some concept or theory has practical potential. A proof of concept is usually small and may or may not be complete.
eHealth describes healthcare services which are supported by digital processes, communication or technology such as electronic prescribing, Telehealth, or Electronic Health Records (EHRs). The use of electronic processes in healthcare dated back to at least the 1990s. Usage of the term varies as it covers not just "Internet medicine" as it was conceived during that time, but also "virtually everything related to computers and medicine". A study in 2005 found 51 unique definitions. Some argue that it is interchangeable with health informatics with a broad definition covering electronic/digital processes in health while others use it in the narrower sense of healthcare practice using the Internet. It can also include health applications and links on mobile phones, referred to as mHealth or m-Health. Key components of eHealth include electronic health records (EHRs), telemedicine, health information exchange, mobile health applications, wearable devices, and online health information. These technologies enable healthcare providers, patients, and other stakeholders to access, manage, and exchange health information more effectively, leading to improved communication, decision-making, and overall healthcare outcomes.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).
IQVIA, formerly Quintiles and IMS Health, Inc., is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research. IQVIA is a provider of biopharmaceutical development, professional consulting and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including investment strategy and management consulting services. It has a network of more than 88,000 employees in more than 100 countries and a market capitalization of US$49 billion as of August 2021. As of 2023, IQVIA was reported to be one of the world's largest contract research organizations (CRO).
A mobile signature is a digital signature generated either on a mobile phone or on a SIM card on a mobile phone.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS. A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in patient recruitment efforts.
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
Biscom, Inc. is a privately held enterprise software company with headquarters in Westford, MA. Biscom's primary focus is to provide secure document delivery solutions to regulated industries. The company develops and markets fax server solutions that facilitate inbound and outbound electronic fax communications, as well as managed file transfer, enterprise file synchronization and sharing, and document conversion solutions. Biscom is known for its ability to scale to deliver millions of documents per day and for a history of reliability that is required for mission critical processes.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
A glossary of terms used in clinical research.
The following outline is provided as an overview of and topical guide to clinical research:
Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results. Patient recruitment can also be challenging, time-consuming, and costly, involving various ethical, regulatory, and logistical issues.
A clinical trial portal is a web portal or enterprise portal that primarily serves sponsors and investigators in a clinical trial. Clinical portals can be developed for a particular study, however study-specific portals may be part of larger, clinical sponsor or Contract Research Organization (CRO) portals that cover multiple trials. A clinical portal is typically developed by a sponsor or CRO to facilitate centralized access to relevant information, documentation and online applications by investigational sites participating in a trial, as well as for the monitors, study managers, data managers, medical, safety and regulatory staff that help plan, conduct, manage and review the trial.
An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process. When the data is captured for a clinical trial, the data is considered a form of Electronic Source Data.
Medidata Solutions is an American technology company that develops and markets software as a service (SaaS) for clinical trials. These include protocol development, clinical site collaboration and management; randomization and trial supply management; capturing patient data through web forms, mobile health (mHealth) devices, laboratory reports, and imaging systems; quality monitor management; safety event capture; and monitoring and business analytics. Headquartered in New York City, Medidata has locations in China, Japan, Singapore, South Korea, the United Kingdom, and the United States.
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
Teprotumumab, sold under the brand name Tepezza, is a medication used to treat adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards.
An electronic trial master file (eTMF) is a trial master file in electronic format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.
