Novartis

Switzerland-based Novartis is one of the top five largest pharmaceutical organizations worldwide. Our data science team assisted Novartis in facilitating hassle-free and quick trial data approval of its new drug for Myelogenous Leukemia, Gleevec, or Imatinib.

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Project Overview

Digital Aptech’s team decided to leverage biostatistics, data science, data visualization and data engineering
We worked in close association with the experts at Novartis for a data-driven approach and solution for faster and compliant FDA approval of the drug in question.

Clinical data submissions to the FDA or any other drug control agency globally can be a time-consuming and complicated task. Rejection of the data trial is a common incident. However, repeated failure for approval can cost the company. c To make the process simpler, pharma agencies often take the assistance of statistics, Artificial Intelligence and Machine Learning. Novartis approached us for crucial biostatistics services for efficient approval of Gleevec.

Client Background

The pharma organization tirelessly works towards combining talent, science and technology to develop and deliver innovative products.
We assisted the biotech giant in its efforts to achieve smoother, faster and hassle-free approval for the drug aimed at treating life-threatening cancer Myelogenous Leukemia.

Challenges

Clinical trial data submission to the FDA and its approval is often a long, tiresome and sometimes challenging task.
Any discrepancy or issues in data can straight away lead to rejection.
The FDA, as part of its review of clinical trial data, needs the organization to answer certain queries and questions.
An accurately developed CSR is vital in the overall drug approval process.

Technologies & Methodologies Used

Biostatistics
PK/PD Modeling and Simulation
Regulatory Data Standards (CDISC) and Compliance
Clinical Trial: SDTM and ADaM
Statistical Consulting and Planning

The Solutions Provided

Solution #1

We assisted Novartis in the submission of appropriate responses with our top-notch post-hoc analysis.

Solution #2

We also aided Novartis in developing FDA-compliant, submission-ready Clinical Study Reports for the drug in question.

Solution #3

Our resources teamed up with Novartis and devised crucial statistical planning for efficient clinical trial and report submission.

Key Features & Benefit

Developing FDA-compliant data set submission for the trials
Efficient and accurate processing of trial data
Carefully designed and detailed CSR for the drug
Detailed post-hoc analysis

The Results

Our services allowed the pharma giant to streamline the drug development process
Faster development and validation of regulatory body-compliant, fully documented and submission-ready SEND, SDTM, ADaM, etc
The inclusion of Biostatistics helped the company in efficient and faster decision-making

Conslusion

Hassle-free data submission ensured a reduced rate of rejection by the FDA
Faster data submission also ensured faster manufacturing and time to market for the said drug
The company managed to save substantial time and funds with a single attempt at clinical data trial approval
Leveraging the power of big data assisted the business in transforming its decision-making process helping to optimize its production

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