Author page: Digital Spring Bio Solution

Medicinal products are to be consumed for a specific purpose. Apart from being effective in treating a particular illness, they need to be safe for consumption. The safety aspect of the medicines is applicable for the products that are on the market as well as those that are being developed and are in different stages…

Drug safety entails safe use of medicinal products. This is applicable for all types of prescription as well as over-the-counter medicines available in the market. It is also applicable for medical therapies indicated for certain disease conditions.  The governing principle for drug safety is indicated for making available products that are safe for use by…

Pharmacovigilance, or drug safety, encompasses the systematic collection, analysis, monitoring, and prevention of adverse effects associated with medications and treatments. This field is wholly scientific and process-oriented within the pharmaceutical industry. An adverse event is defined as any reaction/ unpleasant experience occurring in a patient's body due to a drug or candidate molecule and/ or…

Research programs are classified into two broad categories: Qualitative research and Quantitative research programs. Today we will briefly discuss qualitative research programs. Qualitative research is also known as surveys; the word qualitative means we are going to collect subjective data and not the numbers. For example, if an individual is a smoker or non-smoker, the answer yes/ No will…

In the landscape of clinical research, open trial study designs serve as a pivotal methodological approach aimed at investigating the efficacy, safety, and real-world applicability of medical interventions. Unlike blinded study designs where either the researchers, participants, or both are unaware of the treatment allocation, open trials transparently disclose the treatment assignment to all involved…

Epidemiological surveys play a crucial role in research programs by providing valuable insights into the prevalence, incidence, risk factors, and natural history of diseases within the study population. These surveys help researchers design and conduct more effective clinical trials, understand the context of the diseases being studied, and interpret the trial results. Consider a clinical trial for a…

Case-control studies are a type of observational studies commonly used to compare certain parameters of the diseased subjects vs. the matching healthy subjects. Such studies help to investigate the causes of a particular disease or condition. In a case-control study, researchers compare individuals with a specific outcome or condition (cases) to those without the outcome or condition…

Retrospective studies are carried out a posteriori, utilizing data from past events. Retrospective studies are based on the medical records that have already been collected and are maintained in the registry. Retrospective studies, as contrast to prospective studies, typically don't need to follow patients into the future and take less time to complete. In these studies…

Clinical trials are essential for advancing medical knowledge and improving patient care. Clinical trial is a study conducted in patients as a systematic investigation conducted to evaluate the safety, efficacy, and/or effectiveness of a medical intervention, such as a drug, device, procedure, or behavioral intervention. These studies aim to answer specific research questions and gather real-life evidence…

In general, clinical trials consume a lot of resources. These include time, money, and human effort. One of the main reasons for decentralized clinical trials (DCTs) being popular is due to its ability to optimize resources and to provide review of the live clinical trial data as the study progresses. Consequently, DCTs signify a transformative shift in clinical research,…

Clinical trial programs generates varied data that needs to be carefully collated and reviewed. Traditionally, this data is collected in the customized Case Report Form (CRF) for a specific clinical study. With digital technology, the paper CRFs are getting replaced by electronic CRFs. Therefore, instead of entering the data on the paper, it is entered using computers to…

Decentralized clinical trials (DCTs) have emerged as a transformative paradigm in the field of clinical research, leveraging digital technologies to shift away from traditional in person patient visits and monitoring. All the expected tasks and activities of in person patient visits are enabled virtually through digital technologies. The site monitoring visits are now considerably reduced and…