GSK

GlaxoSmithKline is a widely renowned global biopharma organization focused on combining talent, science and technology to bring a positive impact on global health. The company approached Digital Aptech to develop specialized software to help the brand successfully submit clinical trial data for Tykerb, a breast cancer drug.

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Project Overview

GSK connected with Digital Aptech to develop an appropriate dose-finding strategy that would help in accurate clinical data trial of a breast cancer drug
The company wanted assistance in preparing and developing a CSR or Clinical Study Report that is crucial for drug trial and data submission

GSK is heavily invested in drug discovery and development in multiple key areas of interest, including Oncology, Neuroscience, Ophthalmology, Neglected Tropical Diseases, Immuno-inflation, Bioelectronics and many others. It approached our team to help develop a specialized drug modeling strategy for faster data trial and submission.

Client Background

GSK is involved in vaccine R&D bringing in new vaccine technology as well as working on developing a new and differentiated pipeline of consumer healthcare products. We designed two specific software that helped in making clinical trials for Tykerb smooth, accurate and hassle-free.

Challenges

Clinical data trial submission is a long, tedious and often complicated process. Any error could potentially lead to rejection by the FDA.
During trial data submission, the FDA conducts a scrutiny that includes the regulatory body raising multiple questions or queries.
CSR or Clinical Study Reports are a crucial part of applications sent to regulators for new medical treatments.

Technologies & Methodologies Used

Python
R

The Solutions Provided

Solution #1

Digital Aptech assisted GSK in the hassle-free submission of trial data for Tykerb, a breast cancer drug developed by the organization.

Solution #2

We assisted GSK to successfully fill out these queries through posthoc analysis that accelerated the approval.

Solution #3

Our team developed two customized software, namely Drug Supply Modeling and Optimal Design. The Drug Supply Modeling software predicts the proper supply of drugs needed to cover patient demand in a single study with the risk of drugs running out for one patient. The Optimal Design software helps to identify the appropriate dose-finding strategies for drug development.

Solution #4

CSR or Clinical Study Reports are a crucial part of applications sent to regulators for new medical treatments. We assisted GSK in developing CSR for the above-mentioned drug.

Key Features & Benefit

We successfully incorporated data science, statistical planning, consulting and programming services.
We provided world-class statistical planning, consulting, programming, and other integrated services that helped the company to fast-track research and development for new and improved products.
The Drug Supply Modeling Software helped GSK save $1 billion.

The Results

Conslusion

The organization managed to improve its drug and device development while reducing the overall operational budget.
Our world-class data science and Biostatistics services enabled the organization to utilize the power of big data.
GlaxoSmithKline USA successfully streamlined its product planning, research and development, clinical trials, data submission, and release of products.
The Optimal Design software played a vital role in the research and development of Tykerb.
We assisted our client with data submission of clinical trials to multiple regulatory bodies in compliance with the data standards as laid down. This allowed GlaxoSmithKline to receive faster and hassle-free approvals.

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