Allergan

Allergan is a leading pharmaceutical company involved in developing and manufacturing drugs, biosimilars and medical devices. Digital Aptech assisted Allergan with FDA data submission and approval for whether Botox (Botulinum toxin-A) could be used for treating chronic migraine and urinary incontinence.

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Project Overview

Allergan was looking for faster and hassle-free data submission and our experts had to use biostatistics, Machine Learning and data science to make that happen
We were tasked to develop a compliant CSR or Clinical Study Report which would ensure smooth approval from the central agency

FDA approval is the key to making any drug or medicine available for the global market. This is indeed a crucial milestone for pharma companies trying to bring a specific drug into use. Biostatistics has often proved to be quite beneficial in obtaining such approvals.

Client Background

Allergan is known to offer world-class products for dermatology, medical aesthetics, eye care, urology, women’s health, central nervous system, anti-infective therapeutics and gastroenterology.
Allergan has a rich and promising pipeline of new therapeutics and innovative technologies aimed at providing novel therapies that can bring a paradigm shift to treatment and healthcare.

Challenges

CSR is a highly valuable document that could either make or break the data trial submission.
Clinical Study Reports have to be compliant with all FDA policies and guidelines while accurately displaying and projecting all necessary drug trial data
The entire data submission process can be quite tiresome, complicated and challenging. Passing the procedure requires professional and scientific expertise.

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

With the help of statistical consulting, planning, PK/PD analysis, and data visualization, we documented an accurate and standard Clinical Study Report

Solution #2

Our post-hoc analysis assisted the company in offering satisfactory replies to the crucial questions from the FDA related to the drug data trial

Solution #3

Experts from Digital Aptech provided an FDA-compliant trial outcome in the well-documented CSR.

Key Features & Benefit

Submission of FDA-compliant CSR
Efficient post-hoc analysis
Better analysis of data trial results
Faster and well-documented submission of trial data outcome and summary

The Results

The inclusion of Biostatistics and data visualization helped the company in efficient and faster decision-making
Our expertise and world-class services helped the pharma giant streamline the drug development process
The operational expenses of the company have been significantly reduced with the incorporation of integrated data science technology

Conslusion

We assisted the pharma giant in receiving approvals for clinical data in a more efficient way, which accelerated its product development and delivery.
It enabled product planning, development, and release to be hassle-free, smooth and highly streamlined.
Allergan was able to improve its research and development and fastrack its product development and release in a smart and cost-effective way.
With data science and statistical services from us, the pharma giant enhanced its operational efficiency with respect to particular drug development cycles while reducing expenses.

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