 | This article possibly contains original research .(January 2013) |
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.
eClinical is a term used within the biopharmaceutical industry to refer to trial automation technology. Originally, "eClinical" was used to refer to any involved technology. Without a more specific definition, the industry used "eClinical" to name technologies such as electronic data capture, clinical trial management systems or Randomization and Trial Supply Management systems, commonly using Interactive voice response systems, electronic patient diaries and other applications.
More recently, the term evolved to encompass the entire "business process" instead of individual technologies. [1] An example of an "eClinical solution" is the combination of EDC and IVR systems where common data are shared in a way that eliminates the need for users to enter the same data or perform the same action in both applications. The shift in the definition of "eClinical" has been a natural part of the industry’s evolution to seek better ways to utilize multiple technologies together within a clinical trial.
While individual solutions have helped to automate or streamline particular application areas, maintaining multiple systems containing overlapping data and functionality brought significant inefficiencies. The industry found that eliminating data discrepancies between systems has reduced data reconciliation activities and helped ensure that those responsible for a clinical trial always has accurate and up-to-date information. [2] [3] [4] As the number of relevant applications increases with greater adoption of EDC and other technologies, the problems of duplication of data and redundancy in process have increased. As a consequence, the pursuit of an integrated technology suite to streamline workflows and improve usability has become a key characteristic of the industry’s latest "eClinical" approach. Furthermore, It improves productivity by reducing the need for internal staff to input data.
Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers. [5] [6] [7] CTMSs allow experts easily to access centralized data and thus reducing the number of delayed trials. Sponsors can work with a database of previously researched contacts and names of volunteers who are suitable for participating in a given trial. Clinical trial management systems are cost- and time-effective, as they also can be used for gathering and organizing information that can be shared to different care providers and distributed across different systems. These systems can facilitate site identification and recruitment and they can provide control and tracking over subject enrolment and subjects’ database. [8]
In the early phases of clinical trials, when the number of patients and tests are small, in-house or home-grown programs are typically used to handle their data. In later phases, data volumes and complexity grow, motivating many organizations to adopt more comprehensive software. Available software includes budgeting, patient management, compliance with government regulations, project management, financials, patient management and recruitment, investigator management, regulatory compliance and compatibility with other systems such as electronic data capture and adverse event reporting systems.
In addition to pharmaceutical and biotechnology industries, CTMSs are widely used at sites where clinical research is conducted such as research hospitals, physician practices, academic medical centers and cancer centers.
While pharmaceutical companies that sponsor clinical trials may provide a CTMS to the sites that participate in their trials, sites may operate a CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators, providing a centralized place to house all trial-related information, and improve clinical data management by equipping staff, including biostatisticians and database administrators.
Some CTMS are cloud based and are delivered in a software as a service (SaaS) modality, while others require dedicated servers.
Several Open Source options are available:
Several commercial vendors are available.
A picture archiving and communication system (PACS) is a medical imaging technology which provides economical storage and convenient access to images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets, the folders used to store and protect X-ray film. The universal format for PACS image storage and transfer is DICOM. Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF, once encapsulated in DICOM. A PACS consists of four major components: The imaging modalities such as X-ray plain film (PF), computed tomography (CT) and magnetic resonance imaging (MRI), a secured network for the transmission of patient information, workstations for interpreting and reviewing images, and archives for the storage and retrieval of images and reports. Combined with available and emerging web technology, PACS has the ability to deliver timely and efficient access to images, interpretations, and related data. PACS reduces the physical and time barriers associated with traditional film-based image retrieval, distribution, and display.
Digital Imaging and Communications in Medicine (DICOM) is a technical standard for the digital storage and transmission of medical images and related information. It includes a file format definition, which specifies the structure of a DICOM file, as well as a network communication protocol that uses TCP/IP to communicate between systems. The primary purpose of the standard is to facilitate communication between the software and hardware entities involved in medical imaging, especially those that are created by different manufacturers. Entities that utilize DICOM files include components of picture archiving and communication systems (PACS), such as imaging machines (modalities), radiological information systems (RIS), scanners, printers, computing servers, and networking hardware.
A workflow is a generic term for orchestrated and repeatable patterns of activity, enabled by the systematic organization of resources into processes that transform materials, provide services, or process information. It can be depicted as a sequence of operations, the work of a person or group, the work of an organization of staff, or one or more simple or complex mechanisms.
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.
A Laboratory management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations. Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully "support its use in regulated environments". The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics.
Enterprise content management (ECM) extends the concept of content management by adding a timeline for each content item and, possibly, enforcing processes for its creation, approval, and distribution. Systems using ECM generally provide a secure repository for managed items, analog or digital. They also include one methods for importing content to bring manage new items, and several presentation methods to make items available for use. Although ECM content may be protected by digital rights management (DRM), it is not required. ECM is distinguished from general content management by its cognizance of the processes and procedures of the enterprise for which it is created.
The cancer Biomedical Informatics Grid (caBIG) was a US government program to develop an open-source, open access information network called caGrid for secure data exchange on cancer research. The initiative was developed by the National Cancer Institute and was maintained by the Center for Biomedical Informatics and Information Technology (CBIIT) and program managed by Booz Allen Hamilton. In 2011 a report on caBIG raised significant questions about effectiveness and oversight, and its budget and scope were significantly trimmed. In May 2012, the National Cancer Informatics Program (NCIP) was created as caBIG's successor program.
The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related areas of healthcare". The standards support medical research from protocol through analysis and reporting of results and have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process.
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).
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.
Drug discovery and development requires the integration of multiple scientific and technological disciplines. These include chemistry, biology, pharmacology, pharmaceutical technology and extensive use of information technology. The latter is increasingly recognised as Pharmacoinformatics. Pharmacoinformatics relates to the broader field of bioinformatics.
Business process management (BPM) is the discipline in which people use various methods to discover, model, analyze, measure, improve, optimize, and automate business processes. Any combination of methods used to manage a company's business processes is BPM. Processes can be structured and repeatable or unstructured and variable. Though not required, enabling technologies are often used with BPM.
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.
GIMIAS is a workflow-oriented environment focused on biomedical image computing and simulation. The open-source framework is extensible through plug-ins and is focused on building research and clinical software prototypes. Gimias has been used to develop clinical prototypes in the fields of cardiac imaging and simulation, angiography imaging and simulation, and neurology
ePharmaSolutions (ePS), as a contract research organization, is an American clinical research provider. The solutions include proprietary software applications and global clinical services that focus on the major areas of clinical study delays.
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.
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.
Medical device connectivity is the establishment and maintenance of a connection through which data is transferred between a medical device, such as a patient monitor, and an information system. The term is used interchangeably with biomedical device connectivity or biomedical device integration. By eliminating the need for manual data entry, potential benefits include faster and more frequent data updates, diminished human error, and improved workflow efficiency.
Linguamatics, headquartered in Cambridge, England, with offices in the United States and UK, is a provider of text mining systems through software licensing and services, primarily for pharmaceutical and healthcare applications. Founded in 2001, the company was purchased by IQVIA in January 2019.