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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.

GSK project overview

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.
GSK client

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.
GSK challenges

Technologies & Methodologies Used

Python
Python
R
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.
Key features

Client Praise Collection

Explore glowing testimonials from some of our clients. Learn how Digital Aptech’s innovative solutions and dedicated team have helped businesses thrive.

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Ben Holland
Ben Holland Artist
Clutch

The client was happy with Digital Aptech's work; the team ensured the site included everything the client wanted and worked toward the client's approval. Digital Aptech delivered the website on time and used emails and messages to communicate. Moreover, their affordable pricing stood out.

Edwin Ruzive
Edwin Ruzive CTO, Rainbow Tourism Group
Clutch

The work done so far has been incredible and the client of ours is happy. Thanks to the Digital Aptech team, the website and integration are done according to the specifications with the latest technology stack. The client was most impressed with the vendor's flexibility to work according to their time zone, cost, and payment schedule.

Steve McChesney
Steve McChesney President, Walking Tours Inc
Clutch

It was an excellent experience in every way. Moreover, the end product they delivered surpassed our expectations. Overall, the project was successful.

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