Knowledge Hub
Take advantage of our expertise, In this collection of blogs, white papers, events and publications. Our team shares lessons learned, future projections, and key strategies for success in our industry.
Browse our most recent publications, or filter by topic of interest.
Spatial Computing: The Next Frontier in Patient Care
Introduction Welcome to a new era of patient care where technological developments are transforming the provision of healthcare. Spatial computing is one such innovation that
Kubernetes — Terms, Definitions & Architecture
In the previous post we have covered the basic understanding of K8s, here we will look into the following Kubernetes basic terms and it’s definitions
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
Apple Research & Care Kit
Doctors around the world are using iPhone to transform the way we think about health. Apps created with ResearchKit are already producing medical insights and
The Classic 3 + 3 Design in Dose-finding Clinical Trials and Its Alternatives
Author: Genpro Statistics Team | Date Posted: 28/July/2021 One of the most important goals of Phase 1 clinical trial is to identify the Recommended Phase
Multiple Imputation using SAS and R Programming
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
Handling Missing Values of Continuous Variables in Clinical Data
Author: Genpro Statistics Team | Date Posted: 06/July/2021 INTRODUCTION Missing values are common in clinical data due to varied reasons. The main disadvantage of missing
Components Of Bayesian Approach
Author: Mr. Akhil Vijayan – Bio-statistician at Genpro Research. Bayes theorem is considered as the fundamental theorem in Bayesian statistics formulated by Thomas Bayes. The modern mathematical form
HTA in India: Overview and Update
Authors: Genpro Medical Writing & HEOR consulting group, mw.info@genproresearch.com Background and Need Health technology assessment (HTA) is in discussion for quite some time in India
Implementing Laboratory Toxicity Grading in Sdtm
Oncology is one of the main indications in clinical trials nowadays. One specific method to analyse the oncology data is to review the lab results
Scoping Reviews: A Bird’s Eye View
Evidence-based Healthcare is the “buzzword” in the recent era. Systematic reviews have gained immense interest to advocate an evidence-based healthcare practice. They are nothing but
Conversational Agents In Clinical Trials
Patient enrollment has remained a major challenge for pharmaceutical companies who are conducting clinical trials. Even patients who have the intend to join a trial
Sample Size Determination and Power Calculation A Comparison Between SAS and R
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
Clinical Trials with Interactive Html Graphics Using R
Author: Genpro Statistical Programming Team These days, an immense measure of information is gathered during any clinical trial and it is basic for pharmaceutical sponsors
Enrichment Strategies for Clinical Trials
Author: Athira Sudhakaran – Biostatistics Lead at Genpro Research. Enrichment trials use patient characteristics to select a study population in which detection of a drug
Mobile Applications In Clinical Trials
As mobile phones have become the primary device used by patients for communication and information retrieval, Clinical Trial industry is also finding areas where mobile
Clinical Data and Wearable Device: Future of Data Capturing
Author: Mr. Vinu C Raju – Clinical Statistical Programmer at Genpro Have you ever wondered how your social networking app is suggesting a friend request
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Using Managed Entry Agreements as an Effective Tool to Handle the Uncertainty in Health Technology Assessments
Authors : Vatsal Chhaya | Kapil Khambholja ABSTRACT Although the access to innovative medicines is usually informed by health technology assessment reports, underlying uncertainties in
Automating SDTM – Get It Prepared With Your Voice
Authors Akhil Vijayan, Genpro Life Sciences, Thiruvananthapuram, India Anish George, Genpro Life Sciences, Thiruvananthapuram, India Anoop Ambika, Genpro Life Sciences, Thiruvananthapuram, India ABSTRACT FDA
The Reliability of Mini Nutritional Assessment (MNA) Questionnaire in Screening Malnutrition Among Elderly Aged 60 Years and Above
Anil C Mathew1*, Jomy Jose 2, Athira S2, M Vijayakumar 3 1Professor of Biostatistics, Department of Community Medicine, PSG Institute of Medical Sciences and
Mapping of Oncology Specific Domains in SDTM
The most important part of an Oncology trial is the assessment of tumor lesion and disease responses throughout the study. There are some specific domains
Potential Repurposing of Favipiravir In Covid-19 Outbreak Based on Current Evidence
Scientists across the world are strenuously attempting to find a cure for the COVID-19 pandemic. The efforts have been going on vigorously for the past
The Software as a Medical Device [saMD] Regulatory Landscape in The Us and Europe
The advent of artificial intelligence (AI) in the healthcare industry has resulted in a proliferation of novel health technologies with intuitive features. However, the regulatory
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CTSS
- Oct 27th Thursday
- USA
- San Francisco
BBSW
- 4th Nov Friday
- USA
- San Francisco
PhUSE Conference : Single Day Event
- July 21st Thursday
- USA
- Janssen, Spring House PA
R Studio Conference
- July 27th Wednesday and 28th Thursday
- USA
- Washington DC
Event: PSI 2022 Conference
- June 12 – 15, 2022
- Sweden
- Gothia Towers in Gothenburg, Sweden
Event: ISPOR 2022
- May 15 – 18, 2022
- USA
- Gaylord National Resort & Convention Center, 201 Waterfront Street, National Harbor, MD 20745-1135, United States
Event: OUTSOURCING IN CLINICAL TRIALS EUROPE 2022
- 4th-5th May, 2022
- Barcelona
- Hyatt Regency Barcelona Tower
Event: Phuse US Connect
- 1st – 4thMay, 2022
- USA
- Atlanta
Event: ISMPP Global
Two roundtable sessions at ISMPP Global:
- “A critical analysis of use of STaRT-RWE template for Reporting of Real-World Evidence studies.”
- “Reality check on future of automation in scientific communications: how can we maximize success.”
- May 9-11, 2022
- USA
- Grand Hyatt in Washington, DC, USA
Phuse US Connect
Title View Approachable-and-Scalable-Web-Application-Solutions-using-Shiny-for-Python-and-R-Shiny-in-Pharmaceutical-Industry View Content Future Workforce: How to invest in your team through Innovative transformation. View Content Automation of Standard ADaM Variables Through an
PHUSE EU CONNECT
S.No Connect Stream Title Authors 1 Application Development (AD) Data Catalogues – The new Showman to organize your data, A CRO perspective Limna, Mohin 3
ISPOR Europe 2022
Following 3 abstracts are accepted for presentation at ISPOR EU. Topic Research Type Theme Coinfections in COVID-19 patients in India: a Systematic Review Secondary Epidemiology
Webinar On : Adaptive Designs & Statistical Innovation: Current Trends in Oncology & Rare Diseases
Date : 2 March, 2022 | Time : 9:00 AM PST, 12:00 PM EST, 6:00 PM CET | Place : Virtual Get in Touch shariq.alavi@genproresearch.com
Webinar: In search of a cure for COVID19 – Updates on clinical development modalities
Date : 30 March, 2020 Time : 8:30 am Place : Virtual Genpro Research facilitated the discovery of therapeutic interventions for the Corona pandemic. As part of
Webinar: Applications of Machine Learning in the global fight against COVID-19
Date : 08 April, 2020 Time : 10:30 am Place : Virtual Genpro Research hosted a free webinar on “Applications of Machine Learning in the global
Webinar: COVID-19 & Clinical Research Industry – Global perspective
Date : 13 June, 2020 Time : 6:00pm Place : Virtual Dr. Kapil Khambholja, Vice President Medical Writing, HEOR & RWE at Genpro Research provided update
Free virtual workshop on Systematic Literature Review
Date : 19 July, 2020Time : 2:00pm Place : Virtual Genpro Research brings you “Online Workshop on Systematic Literature Review” on 19.07.2020, from 2 PM to
PharmaSUG 2020 Webinar – Virtual
Date : 21 July, 2020 Time : 11:00am Place : Virtual We are presenting two papers at PharmaSUG 2020 virtual webinar on the following topics.
An AI-Powered Device to detect Diabetic Retinopathy & Associated Statistical Deliberations
Date : 30 July ,2020 Time : 9:30am Place : Virtual The Diabetic retinopathy detection device, world’s first AI-powered device to receive US Food and
