Time to read: 5 mins.
Data-Driven Project Management in the context of clinical trials is essential for enhancing efficiency and ensuring the integrity of research outcomes. By leveraging statistical methodologies, advanced analytics, and real-time data monitoring, project managers can make informed decisions that facilitate the successful execution of clinical studies. This approach not only mitigates risks but also optimizes resource allocation, thereby contributing to the overall advancement of medical research.
A Dashboard Calculator for Pre-Clinical Trial Design
Genetic skeletal conditions are primarily attributed to autosomal dominant genetic mutations and are frequently identified at birth or no later than the age of two. Achondroplasia, one of the most widely recognized genetic skeletal disorders, has a prevalence rate of approximately 1 in 15,000 individuals. Patients diagnosed with this condition often experience associated comorbidities, including respiratory issues, recurrent ear infections, obesity, and an increased risk of cardiovascular disease in adulthood.
The objective of height growth acceleration therapies is to diminish the necessity for invasive surgical procedures, such as Chiari surgery, among pediatric patients. Prompt diagnosis and treatment can substantially reduce the requirement for invasive interventions and the associated risks of postoperative complications. Although life expectancy for individuals with achondroplasia is estimated to be 3 to 5 years shorter than that of the general population, it is essential to recognize that advancements in modern medicine, surgical techniques, and efforts to enhance patients’ quality of life (QoL) have contributed to narrowing this gap in life expectancy.
Implementing minimal or non-invasive treatments can not only mitigate the need for high-risk surgeries but also enhance patients’ overall QoL.
We invite you to view our demonstration video, which features the following components:
i) a questionnaire designed to assess quality of life;
ii) an analytical flowchart illustrating disease progression from birth to surgical intervention;
iii) a simulation employing real-world evidence (RWE) numeracy;
iv) a comparative analysis of various hospitals and their associated intervention costs.
Each of the aforementioned elements can be presented in separate interfaces tailored to the appropriate end-users. N.B., view in full-screen mode for better visual experience. ♤
This demonstration is not associated with any product related to height growth acceleration of biopharmaceutical companies. For inquiries regarding customized UI design and predictive model calculations, please contact us at contact.general@keras360.io for further information.
FAQs
Q1: How does the timeline and cost function for pre-clinical trial designs?
Keras360 advises its clients to establish communication at the earliest feasible opportunity to articulate the intent and objectives of the study design. This proactive approach will facilitate the assessment of the project timeline, ascertain the necessary sample size, and utilize existing knowledge pertaining to the study in question, including treatments, medical regimens, disease prevalence, and the demographic characteristics of the affected population. While the submission of forms for clinical trials and research ethics is pending approval, this interim period may provide investigators with a valuable opportunity to gain insights into potential factors that could influence outcomes, thereby reducing the risk of bias in patient selection to ensure reliable results.
A minimum of 80 work hours (equivalent to 2 weeks) is established as the baseline for general preparatory activities. Furthermore, at least 100 work hours will be required to develop, optimize, and integrate the user interface. A quotation sheet detailing the total estimated costs will be provided.
The transfer of intellectual property and copyrights will be addressed on a case-by-case basis, contingent upon specific factors such as drug patent considerations. ♤
Q2: As a consumer, what should I know about the warranty coverage?
At Keras360 The Waterhouse, we recognize that principal investigators and clinicians adhere to an interim timeline prior to the initiation of a clinical trial. Consequently, our calculators and/or user interfaces (UIs) that are fully acquired come with a warranty valid for a period of 12 months, allowing sufficient time for researchers to become acquainted with the technical components and to master the analytical outputs. This warranty encompasses limited liability for certain minor modifications, which include fine-tuning and range adjustments to embedded parameters within the approved protocol blueprints; alterations to the positioning of input fields and output content; as well as changes to integrated links to the Cloud server. Each product is supplied with a warranty checklist. ♤
Our values
Our mission is to develop calculations that accurately represent real-world data. Clinical trial studies have long been regarded as the gold standard in medical research regarding interventions and disease treatments; however, the associated costs, success rates, and the meticulous planning required to obtain meaningful results are often underappreciated. Clinical trials integrate knowledge from both analytical and medical research disciplines. At Keras360, we endeavor to assemble experts from these fields to formulate comprehensive analytical designs and calculations that reflect real-world scenarios and evidence. ♤
Work with us
If you are an epidemiologist or biostatistician with expertise in developing study designs for clinical trials and/or preventive medicine, including vaccinations, vector-host models, time-series analyses, or survival models, we respectfully invite you to submit your curriculum vitae along with a list of your publications.
contact.general@keras360.io
The following prerequisites are essential:
– The candidate must possess a Master of Science or Ph.D. in a quantitative discipline pertinent to medical studies, such as Epidemiology, Biostatistics, Genetic Epidemiology, or Public Health. Furthermore, the candidate should demonstrate a comprehensive understanding of survival models, including Kaplan-Meier plots, Nelson-Aalen Cumulative Hazard, semi-parametric Cox models, and various other multivariate models.
– Proficiency in the design of analytical studies and the formulation of novel mathematical equations to address public health and epidemiological challenges is imperative.
– The capacity to extract pertinent parameters from scientific literature and illustrate the significance of each parameter within the constructed model, including sensitivity analysis, is required.
– A foundational understanding of Systematic Literature Review and Meta-analysis, along with text mining techniques, will be regarded as advantageous.
Other RWE examples:
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