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The authors propose a blockchain platform for managing clinical trial data to enhance data validity, integrity, trust and transparency in the pharmaceutical research process. The authors also provide an extensive review of how blockchain technology supports the business processes of clinical trials.

A systematic literature review was conducted to identify the existing applications of blockchain in pharmaceutical process management. A conceptual design for a blockchain infrastructure to address clinical trial challenges is developed by outlining the entire clinical trial value chain and identifying the coordination and communication among its stakeholders. A stakeholder analysis is conducted to ensure that the clinical trial processes satisfy the requirements and preferences of each stakeholder.

The proposed blockchain platform offers a promising solution for enhancing integrity, trust and transparency in the clinical trial process. Additionally, blockchain can help streamline communication and collaboration between stakeholders by enabling multiple parties to access and share data in real time, lowering the possibility of delays or errors in data analysis and reporting.

The proposed blockchain platform can benefit patients by empowering them to have better-controlled access to their data and by allowing researchers to maintain adherence to reporting requirements. Additionally, the platform can benefit granting agencies, researchers and decision-makers by ensuring the integrity of clinical trial data and streamlining communication and collaboration between stakeholders.

This study builds on existing blockchain applications in pharmaceutical process management by developing a blockchain framework that can address clinical trial concerns from an integrated perspective.

The purpose of this paper is to report on the decision process that the authors follow in applying mixed methods research to evaluate the benefits and costs of conducting sponsored clinical trials in a publicly funded New Zealand hospital.

A simultaneous parallel mixed method design was adopted. This design builds on a health outcomes study that involves a retrospective cohort study of changes in participants' health status and mortality rates. Although a team of medical researchers conducted that study (i.e. the current authors were not involved), it is one of the three strands of the current research as it forms the platform for the other two strands, namely the multiple stakeholder perception strand and the economic outcomes strand. In the multiple stakeholder perceptions strand, qualitative methods were used to explore the benefits and costs perceived by stakeholders. In the economic outcomes strand, quantitative methods were used to estimate the benefits and costs of clinical trials.

The economic outcomes strand and the multiple stakeholder perceptions strand are complementary. Each strand delivers dimensions to the analysis that are not apparent from the other.

The value of the paper lies in improved understanding of the process of mixed method research through communicating choices and decisions made in response to the challenges faced.

The purpose of this paper is to provide an overview of knowledge capture in the biopharmaceutical industry, focusing primarily on the transition from paper‐based to electronic data capture (EDC) systems.

The paper draws on biopharmaceutical industry literature and data from example clinical studies to describe the issues involved in transitioning to EDC in the clinical trials environment.

While electronic data capture systems provide greater efficiencies along the clinical trial supply chain, the industry is still far from achieving wide scale utilization of such technologies. The barriers to successful implementation are multifaceted, involving not only the information technology itself, but also user acceptance issues, lack of interoperability standards, and regulatory compliance. Major shifts in organizational culture and a unified effort within the industry will be necessary in order to derive full benefits from electronic capture systems in the future.

This study was limited in that case data from only one company was used to supplement the literature review. Further research is warranted to better understand the factors that facilitate adoption of electronic knowledge capture systems in the biopharmaceutical industry.

While the need for knowledge management in the healthcare industry is indisputable, there has been remarkably slow progress in this area, and a dearth of research exploring implementation issues. The value of this type of inquiry is profound as it will help us better understand the issues in implementation and adoption, and ultimately to deliver more effective and safe drugs to the public in a more efficient manner.

If the use of information technology (IT) supporting clinical trial projects offers opportunities to optimize the underlying information management process, the intricacy of the identification and evaluation of relevant IT options is generally seen as a complex task in healthcare. Hence, the purpose of this paper is to examine the problem of ex ante information system evaluation, and assess the impact of IT on the information management process underlying clinical trials.

Combining Unified Modeling Language (UML) and system dynamics modeling, a simulation model for evaluating IT was developed. This modeling effort relies on a case study conducted in a clinical research organization, which, at that time, faced an IT investment dilemma.

Some illustrative results of sensitivity analyzes conducted on error rates in clinical data transmission are presented. These simulation results allow for quantifying the impact of different IT options on human resources' efforts, time delays and costs of clinical trials projects. Notably, the results show that although the technology has no real influence on the duration of a clinical trial project, it impacts the number of projects that can be carried out simultaneously.

The research provides insights into the development of an innovative approach appropriate to the evaluation of IT supporting clinical trials, through the use of a mixed‐method based on qualitative and quantitative modeling. The results illustrate two critical issues addressed in the IS literature: the necessity to extend IT evaluation beyond the quantitative‐qualitative dichotomy; and the role of evaluation in organizational learning, and in learning about business dimensions.

This systematic review aimed to identify and categorize applications using Fast Healthcare Interoperability Resources (FHIR) to support activities outside of direct healthcare provision.

A systematic electronic search was performed, and 53 studies were included after the selection process.

The results show that FHIR is being used to support (1) clinical research (i.e. clinical research based on interventional trials, data interoperability to support clinical research and advanced communication services to support clinical research), (2) public health and (3) medical education. Despite the FHIR potential to support activities outside of direct healthcare provision, some barriers were identified, namely difficulties translating the proposed applications to clinical environments or FHIR technical issues that require further developments.

This study provided a broad review of how FHIR is being applied in clinical activities outside of direct clinical care and identified three major domains, that is, clinical research, public health and medical education, being the first and most representative in terms of number of publications.

After a successful transition from a projects-based IT business services company to a platform-driven analytics company, Saama's core leadership team gathered in 2017 to brainstorm the next phase of its growth. The year before, the team had decided to narrow its target market to the life sciences vertical. Saama now had to decide how to execute on this focused strategy by choosing a growth pathway within the life sciences vertical. Saama's leadership team was considering three alternatives: acquiring new customer accounts, developing existing customer accounts, or developing new products by harnessing artificial intelligence (AI) and blockchain technologies. The team had to evaluate these growth pathways in terms of both short- and long-term revenue potential, as well as their potential for sustaining Saama's competitive advantage.

The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic development.

Exploratory review of clinical trial processes of three industrialized nations with similar democratic processes – Japan, the UK and the USA – in order to determine the efficacy of international clinical trials.

Outstanding best practices in national vaccine clinical trials can guide the international economic development, manufacturing and distribution policy strategies necessary to form the basis of a cross‐cultural global delivery system.

This study's contribution to academic literature is threefold: first, it reviews established fundamental clinical trial processes for Japan, the UK and the USA; second, it distinguishes similarities and differences to determine best practices; and third, it suggests changes in regulatory vaccine clinical trials towards achieving global health objectives.

The healthcare sector in India is witnessing phenomenal growth, such that by the year 2022, it will be a market worth trillions of INR. Increase in income levels, awareness regarding personal health, the occurrence of lifestyle diseases, better insurance policies, low-cost healthcare services, and the emergence of newer technologies like telemedicine are driving this sector to new heights. Abundant quantities of healthcare data are being accumulated each day, which is difficult to analyze using traditional statistical and analytical tools, calling for the application of Big Data Analytics in the healthcare sector. Through provision of evidence-based decision-making and actions across healthcare networks, Big Data Analytics equips the sector with the ability to analyze a wide variety of data. Big Data Analytics includes both predictive and descriptive analytics. At present, about half of the healthcare organizations have adopted an analytical approach to decision-making, while a quarter of these firms are experienced in its application. This implies the lack of understanding prevalent in healthcare sector toward the value and the managerial, economic, and strategic impact of Big Data Analytics. In this context, this chapter on “Predictive Analytics in Healthcare” discusses sources, areas of application, possible future areas, advantages and limitations of the application of predictive Big Data Analytics in healthcare.

This paper proposes an “innovative” approach to the evaluation of information systems projects to support pharmaceutical clinical trials. The IS evaluation process for these projects closely follows that described in the Management of Innovation literature using methods which are highly iterative and are an integral component of the project. The development of organization‐technology fit is core and evaluation for this purpose can be thought of as a coupling mechanism between use and design and as a tool for continuous learning and improvement. This integrative, iterative approach is applied to a project undertaken at Glaxo Wellcome Research and Development.

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed in relation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.