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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.
Download Case StudyProject 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
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

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