Introduction to Kubernetes in 2023
The MaiA project codebase is in active development, and the team has finally achieved a continuous integration and continuous deployment workflow. We encountered situations that required the streamlining and automation of some of the frequent, repetitive processes of service updates, scaling, deployment to specific servers (development or stage or production), health checks, monitoring, and so […]
Study Design and Analysis in Clinical Research using R: Sample Size Estimation and Power Analysis
Introduction: A critical step in clinical trial design is to accurately determine sample size. A wrong sample size can doom your study from beginning. If the sample size is too small, the population being examined will not be effectively represented and may risk the validity of study results. A large sample size magnifies statistical differences […]
Walkthrough SDTM 3.3 Vs 3.4
In November 2021, the SDTMIG v3.4 and SDTM v2.0 were released. Since 2004, CDISC has provided an accepted standard for the submission of tabulation data in the form of the SDTM and SDTMIG. A large amount of information, as well as new tables, including those for domain specific variables, has been updated to the most […]
Multiplicity in Clinical Trials
The terms pharmacogenomics and pharmacogenetics refer to the study of how a person’s specific genetic sequences influence how they respond to medications. Pharmacogenomics aims to develop reasonable methods for improving therapies in relation to the patient’s genotype in order to achieve maximum effectiveness with the fewest side effects. Pharmacogenomics enables us to identify inter-individual differences […]
An Overview of CDISC Genomic Standards
The terms pharmacogenomics and pharmacogenetics refer to the study of how a person’s specific genetic sequences influence how they respond to medications. Pharmacogenomics aims to develop reasonable methods for improving therapies in relation to the patient’s genotype in order to achieve maximum effectiveness with the fewest side effects. Pharmacogenomics enables us to identify inter-individual differences […]
Adding values to clinical trials: decentralized clinical trials and tech enabled clinical operations
Author: MW & Biometrics team – Genpro It’s not important how many pieces you have, but how you connect them that leads to the result. Had anybody ever thought about maximal use of electronic means for clinical trial operations before a few years? Certainly not, isn’t it! However, decentralized clinical trials (DCT) has been the […]
Clinical Trial Diversity: An Emerging Paradigm in Outcomes Research
Author: Genpro MW & Evidence synthesis team “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” – Dr Tedros Adhanom Ghebreyesus Director-General, World Health Organization ‘Right to heath’ and universal health coverage has been […]
Sample Size Determination and Power Calculation – A Comparison Between SAS and R Programming
Author: Genpro SAS/R Programming Team Choosing the proper sample size for an investigation is one of the crucial jobs required of a statistician. Regardless of whether the statistician is deciding the number of patients to select in a clinical trial, electors to finish a political survey, or mice to remember for a lab experiment, the […]
CDISC Programming: Importance of Custom Checks
Author: Genpro Statistical Programming Team SDTM-domain structures and relationships are similar across studies under a therapeutic area which leads to code standardization and reusability. Interim data transfers also come with changes in data leading to rerun of existing programs with minor updates. The possibility of errors in such scenarios are large with truncation in data, […]
Artificial Intelligence (AI) Innovations in Clinical Research
Author: Thalla Sanjeeva Reddy – Clinical SAS Programmer at Genpro Introduction Majority of drugs take about 10 years or more to come to market, cost billions, and have a potential to even demolish an organization in certain cases where the late-stage trials fail after having poured in so much speculation. Also, Patients hardly can wait 15 years […]
