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 […]

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 […]

Harnessing AI to expedite evidence generation & reporting

Authored by:   MW & Evidence Team at Genpro Research Inc. Given the ever-increasing advocacy and preferences for evidence-based healthcare models, clinicians and the research community have been emphasizing and relying on high-quality evidence. On the other hand, the rapid proliferation of biomedical literature has resulted in the infodemic, posing great challenges for medical and scientific […]

Biostatistics Case Study #02: To study the difference in the impact of Unblinded and Blinded Sample Size Re-estimation (SSR) methods when there is uncertainty regarding the actual effect size

Author: Genpro Statistics Team Multiple imputation is highly recommended as a valid method for handling missing data. It eliminates the disadvantages of reduction in statistical power and under estimation of standard errors in single imputation. SAS, an established software having robust tools, and R, an open-source software where users can develop packages, differ in various […]

Biostatistics Case Study #01: Interim Analysis using Adaptive Randomization

Adaptive randomization refers to any scheme in which the probability of treatment assignment changes according to assigned treatments of patients already in the trial. The covariate adaptive randomization (CAR) is usually used instead of pure randomization to reduce the covariate imbalance between treatment groups in clinical trials. Allocation probability for the covariate adaptive randomization is […]

Data Monitoring Listings in Clinical Research

Author: Genpro Statistical Programming team. Introduction Clinical trials in the pharmaceutical industry have always its challenges, as providing quality data ethically and fairly for the submission is difficult. Clinical Data Management (CDM) team reviews multiple numbers of reports on a daily, weekly, and monthly basis or at various frequencies to produce quality data. A single […]

The Trial Summary Domain Puzzle

The-Trial-Summary-Domain-Puzzle

Author: Genpro Statistical Programming Team Trial Summary Domain [TS domain] – A jigsaw puzzle among the SDTM Trial domains where we need to put together the pieces of the study in a structured way to get a complete picture. This domain is often challenging either in determining the number of parameters required or in getting […]