The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before. Virtual clinical trials are not just a temporary solution to the challenges posed by global events like the COVID-19 pandemic. They represent a long-term evolution in clinical research, driven by the need for more flexible and inclusive trials with the increase in rare diseases, geographic barriers and understa ..read more

Clinical trial professionals are well aware of the unique challenges presented by oncology, a therapeutic area dedicated to the prevention, diagnosis, and treatment of cancers. When it comes to designing Case Report Forms (CRFs) for oncology studies, considerations become more intricate due to the nature of the therapeutic area, the complexity of tests and examinations, as well as the specific data required for statistical analysis. In this article, we delve into key CRF design considerations for oncology clinical trials ..read more

Case Report Forms (CRFs), which are now more commonly known as Electronic Case Report Forms (eCRFs) given the industry's shift to digital technologies and move away from paper over the past two decades, are the most frequently used tools to capture clinical data of subjects enrolled on clinical trials at investigational sites ..read more

Clinical trials although methodically planned, can hit unexpected roadblocks steering them off course. From resource shortages and unforeseen service needs to contractual issues, recruitment problems and adverse events, these challenges can bring even the most carefully planned trials to a grinding halt. With strict deadlines, limited budgets and often tight resources, it can be difficult to determine the exact problem to navigate around, particularly when time is of the essence. These challenges however don’t have to signify the end of the road, a rescue study if executed promptly to address ..read more

What is an ISS and an ISE? The integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) are critical documents required for regulatory submissions in the approval of new medicines/drugs or devices. These documents combine the safety and efficacy results from different clinical trials conducted for the investigational product and need to contain detailed analyses of all relevant data from the individual clinical study reports. ISS and ISE allow reviewers to compare results for individual endpoints across studies for the investigational product. Overall, ISS and ISE enab ..read more

In this article, we delve into six key clinical data management practices for the complex terrain of biotechnology trials. From setting clear study objectives to embracing risk-based quality management, these practices underscore the industry's commitment to precision, efficiency, and innovation as it propels itself into the future. These practices are driven but evolving technologies that are helping to shape the clinical data management stage of drug development.   ..read more

R is the open source software environment and language used for data analysis and statistical computing. A great deal has already been said and written about R’s wide variety of graphical and statistical techniques. Even though R as a programming language is constantly growing in popularity in the pharmaceutical industry, it is still quite unpopular to use R in the preliminary stages of research like importing data from different sources, tidying it, calculating new variables in datasets and making other amendments available in SAS data steps. This blog explores the ways R can come in useful ..read more

Patient safety has been the primary focus of clinical trial design since 1947 when the Nuremberg code outlined the ethical guidelines for clinical research. Trials must be designed to avoid injury or suffering and patients must give consent and are free to leave the trial at any point. The current world of drug development governed by ICH-GCP makes it mandatory to have all necessary steps taken by sponsors, CROs and investigators to keep patient safety as utmost priority ..read more

The use of R programming in clinical trials has not been the most popular and obvious, despite its recent growth over the past few years, its practical use still seems to be hindered by several factors, sometimes due to misunderstandings, (e.g validation) but also because of a lack of knowledge of its capabilities. Despite these bottlenecks, though, R is doubtlessly creating its own (larger by the day) niche in the pharmaceutical industry. In this blog we will see how R can be used to create TLFs much like the current combination of PROC REPORT/PROC TABULATE and the ODS currently does, thus s ..read more

Until 2007, the Food Drug & Administration (FDA) and the biopharmaceutical industry were grappled by the non-standardized sources of data. Gathering all the heterogenous data and mapping to the internal standards of the pharma companies proved to be the greatest challenge of the time. By the end of 2007, and towards the beginning of 2008, the Clinical Data Interchange Standards Consortium (CDISC) gained ground in its mission to develop a global set of standards. Eventually, CDISC began shaping the entire industry as FDA started requesting submission data in standardized formats, though CD ..read more