Case
Huckman, R., Cotteleer, M. (2006). Proctor and Gamble: Electronic Data Capture and
Clinical Trial Management. Harvard Business School 9-606-033. Boston, MA: Harvard University Press.
Overview
This case considers the organizational question of whether Proctor & Gamble Pharmaceuticals should adopt web-based electronic data capture (EDC) as the default standard for the management of clinical drug trials. The study provides a broad overview of the existing process and asks how information management can improve processes within the organization. An interesting sub-plot is the psychological barriers to adapting new technology, and the consideration on how a firm should structure internal and external relationships with providers of new technology (Huckman and Cotteleer, 2006)..
Web-Based Electronic Data Capture
An electronic data capture system is a computerized system specifically designed to collect and analyze clinical data in specific electronic format. It is mainly used in human clinical trials and provides a graphical user interface, a validation component, and a reporting tool that aids in the analysis of the data. It is a specific tool that can increase data accuracy and decrease time to collect data for studies on drugs and medical devices that make it an ideal tool for the pharmaceutical industry. The technology has been around since the 1970s but did not become practical until the 1990s. The costs to set up are relatively high, but the cost benefit
The managers at the pharmacy department, as team members were involved in the study. Although the study was anonymous, it is presumed that their input and expectations towards the e-Rx could have been different from the non-management staff. What they consider priority may not be the same for the staff members. Their preferences in workflow and employee training provided valuable input in the study.
Two organizations migrating to a common health information system would need a system that meets current regulatory requirements, meets the needs of the combined organization and their practice environment. The implementation of a common health information system would require an interdisciplinary group of forward thinking innovators, and an interoperable electronic medical record system that includes standard nursing terminology.
A computerized clinical database consists of clinical data for storing, retrieving, analyzing, and reporting of information (McCartney, 2012).
An information technology strategic plan developed by Langley Mason Health (LMH) aimed to empower health care consumers and healthcare workers to change data into information to expand services of the clinics as well as electronic medical records. However, there are insufficient funds for equipment, technology and routine maintenance for its facilities (Wager, Lee, & Glaser, 2009). The hospital planned to construct several satellite locations and there are limited funds left yearly to spend on technology implementation and to purchase equipment. The LMH system had a delay in fully going live with computerized prescribers order entry (CPOE) because of many foreseen complications during the development (Wager, Lee & Glaser, 2009). While the issue of CPOE implementation is being resolved, pharmacy and nursing department is looking at the purchase of smart IV pump that will spend roughly half of the budget for the fiscal year. This paper discusses the case study about LMH, different views how LMH should proceed and how to mediate the two different views.
This case analysis of Stanford’s Hospital and Clinics (SHC) electronic medical record (EMR) system implementation will focus on how the healthcare organization focused on resolving a problem to meet regulatory pressures and responded to an opportunity to create operational efficiency, by capitalizing on the use of information technology to help reduce costs. We will discuss the organization’s IT problems, opportunities, and the alternatives available to address each. We will summarize an analysis of potential alternatives including the organization’s EMR system of choice and conclude with a recommendation to the Board on how to rollout the new system.
The SCHC addressed meaningful use by recording patient demographics, maintaining an active medication lists and incorporating clinical lab test results into the HER, as apart of their meaningful use objectives. For recording patient demographics, they maintained data for accurate billing and ensured that the practice workflow was adjusted to capture all of the necessary patient data. They addressed active medication lists by following the requirements for e-prescribing. Patients were able to review their active medication list during their visit. Changes to the medication list were reviewed with the nurse and adjusted within the EHR system by the doctor. They communicated information for the care coordination process by making test results efficient and safe to access. Physicians were able to make real time decisions when they receive the test results from LabCorp, Quest, and other health
We all know that it can be very hard and difficult to get use to change, mostly when a single person has become accustomed to doing the medical records the old fashion regular way. Nonetheless, there has been new technology keep arriving and it’s making the medical record so much easier with the innovations of today world. So the management must make changes to compose and motivate their employees so that they can be gladly fine of the new technology (Robbins, 2011). Healthcare are starting to use electronic medical records for different services across the health care world, although the change is not
Data that is captured in a clinical trial should represent all of the Investigator’s observations that have occurred with any given subject over the course of the study. Data entry in a study is usually single or double captured. When data is double captured, it increases accuracy due to two different entries but two operators. Data entry screens are an effective way of capturing double data. Once data is
The data collected through computers during single research are used to synthesize evidence to guide the best care. After the synthesis of evidence, the evidence has to be translated into practice. The incorporation of EBP into the information system in healthcare has been possible to aid the clinician with their decision making.
At a clinical trial setting data entry is one of the most fundamental tasks performed by a study coordinator. This is the focal reason why drugs are tested in order to provide the raw data required for the overall analysis in determining if they met the study endpoints. Furthermore to build a profile of the drug in regard to its safety and efficacy. Therefore, it is important to collect reliable data obtained from the patient entering the data via the electronic case report form (eCRF). It should be noted that some study sites still use the paper form of the CRF where the majority of the sites are now leaning more to the electronic versions. Data entering is a very time-consuming task which can be influenced by how the sponsor has decided to design the CRF, which can vary from being quite straightforward to be very convoluted. Therefore, training is required in learning how to navigate the sponsors’ data system followed by having your name entered onto the delegation log which is signed by the principal investigator, in order to be permitted to enter any sort of data. This is a rough idea of what I have been doing these couple of weeks, so I can aid in relieving some of the burdens for my
Before an investigational study on a new drug may take place, research subjects must submit informed consent and informed of all possible risks and benefits of the therapy. There are four types of phases associated with investigational studies that may occur. Beginning with the first phase, a Phase I study consist of few healthy participants who do not have the disease that the certain drug is said to treat. The purpose of this phase is to determine the optimal dosage range and the pharmacokinetics of the drug and if further testing of the drug is necessary. Vital signs, blood tests, urinary analysis, and other specific monitoring exams are performed. The next phase, Phase II, also involves a relatively small number of participants who this time have the disease that the drug is designed to treat. Participants are closely monitored to determine the effects and adverse
The success of the HMIS is critical for the future of Electronic Health Records (EHR). There are many critical factors that affect the success of HMIS implementation in healthcare. The management is encouraged to assess these factors before any initial implementation of the program. The adoption of the HMIS relies in the capabilities of the management to overpass the barriers and limitations during the process of implementation. For the most part there are three major contributors to the limitations in the adoption of HMIS. The three major limitations include: organizational characteristics, user characteristics, and system design characteristics (Tan & Payton, 2010). Organizational characteristics influence the implementation of HMIS, in which
Electronic case report form (eCRF) is a platform in which electronically maintained information about an individual’s lifetime health status and health care records can be stored and serve as a case report form of patients in clinical trials (1). eCRF helps individuals access, manage, and share their health information with others who are authorized, in a private, secure, and confidential environment (2). eCRF integrates many different aspects of clinical trials such as data mining, data cleaning, and data capture into one system and contributes greatly in clinical trial management.
It is generally accepted that information is a vital commodity for the successful operation of today’s organizations. Nowadays modern business organizations are using computerized information systems in order to obtain such information. However as the technology advances rapidly the main issue is how can an organization should effectively use such an information system - which its management sometimes can be unpredictable - in order to effectively help the whole organization structure to improve and take the most out of it.
Companies are adopting more to ICT, Information Communication Technology. ICT is not just doing the same old stuff the same old way. It’s taken the same old stuff and making it more efficient by making it different through process innovation or doing new things through product innovation. ICT adoption brings on innovation and change. What inspires organizations to adopt these changes? Changes are adopted on the basis that some organizational expected innovations that would make their organization more advances in order to meet the changes in technology. The successful implementation of technology brings about organizational and behavioral changes. An organizational change views ICT implementation as a process involving technical change