Skip to main content 
Forbes India Select 200 Clutch 1000 GoodFirms D-U-N-S Registered

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.

Download Case Study
Confidentiality Assured Zero Spam Commitment

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.

Roche project overview

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.
Roche client

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
Roche challenges

Technologies & Methodologies Used

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

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
Results

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.

Client testimonial video

Discover How Our Innovative Solutions Have Transformed Businesses And Exceeded Client Expectations.

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.

Got An Idea? We Are Ready To Turn It Into Reality

Connect with our team and we will get back to you at the earliest to hear you out.

Confidentiality Assured Zero Spam Commitment

Why Choose Us?

Opt for Digital Aptech and experience our unparalleled expertise in innovative technologies, personalized solutions, and a relentless drive to elevate your business. Join our journey of excellence and innovation.