Roche

Roche is a leading Switzerland-based multinational pharmaceutical organization that operates on two of its main divisions: pharmaceuticals and diagnostics. The company associated with Digital Aptech to avail of our world-class data science services for smooth clinical data trial submission and approval of Polivy, a Lyphoma-fighting drug.

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Project Overview

Our specialized big data experts, data visualization experts and data science professionals formed an actionable team and devised a unique plan
We worked on incorporating biostatistical services for smooth data trial approval and accurate clinical report submission

Clinical data submissions to any central drug control agency are often quite challenging tasks consisting of multiple scrutiny, data trials, questions and counterquestions. To make the process simpler, pharma agencies often take the assistance of big data. Roche collaborated with us to avail crucial biostatistics services for smooth drug approval.

Client Background

Roche has an illustrious past with more than 30 life-saving medicines on the list of World Health Organization Model Lists of Essential Medicines.
Our team assisted the pharma giant on its goal to ensure assured clinical drug trial approval for one of its revolutionary drugs Polivy.

Challenges

Clinical trial data submission is a crucial and complicated task compromising multiple rounds of investigation, data trial and investigations
During clinical trial data submission, the FDA puts forward multiple questions and queries as part of the scrutiny. Accurate replies will ensure smooth drug approval
A submission-ready and fully documented CSR is crucial for drug approval. It summarizes the overall outcome of a clinical study to the FDA. CSR ensures speedy drug approval

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 Roche in trial data submission to the FDA for Polivy.

Solution #2

Digital Aptech, through its post-hoc analysis, aided in the queries that are conducted during drug data trials in the CDC. This was instrumental in faster approval.

Solution #3

We carefully developed and validated FDA-compliant and acceptable Clinical Study Reports for the Lymphoma drug.

Solution #4

Our team also provided world-class and industry-leading design and analysis of clinical trials

Key Features & Benefit

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

The Results

The inclusion of biostatistics and other integrated services enabled the organization to leverage the potential of data science
Overall operations expenses of the company have been successfully reduced with the incorporation of integrated data science technology
Streamlined data submission for clinical trials in accordance with regulatory body guidelines has encouraged smoother trial approvals

Conslusion

Faster clinical data trials improved the company’s overall productivity and brought down costs
Smooth drug trial data submission meant more credibility of the pharma company
Hassle-free data submission ensured on-time approval resulting in faster time to market of the drug in question
Leveraging the power of big data assisted the business in transforming its decision-making
Our services opened ways for the brand to use big data for other drug trials and data submissions

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