Novartis

About the Client

Switzerland-based Novartis is one of the top five largest pharmaceutical organizations worldwide. At Novartis, the primary objective is to reimagine medicine and develop world-class healthcare solutions to help extend and improve the quality of lives. The organization tirelessly works towards combining talent, science and technology to develop and deliver innovative products.

Also, Novartis aims to reward its shareholders who dedicate their time, effort or money towards the organization. The organization has five business segments and an industry-leading portfolio focused on revolutionizing the standard of healthcare for individuals worldwide.

Some Revolutionary Novartis Drugs

• Tasigna for Myelogenous Leukemia
• Gleevec for Myelogenous Leukemia
• Valsartan for high blood pressure and kidney disease
• Xolair for Asthma
• Zykadia for non-small cell lung cancer
• Lenalidomide for Myeloma

Client Details

Name: Novartis

Industry: Pharmaceutical

Geographic Location: Switzerland

Novartis Partnered with us for:

Novartis collaborated with us for the following world-class services that we provided them with:

Biostatistics

Experienced professionals at KnowTechInfo provide specially curated biostatistics services for studies across pre and post-development phases. Our team has the necessary skill and expertise to provide any or all of the following statistical services:

• Protocol development
• Exploratory analyses and data mining
• Randomization schedules
• Support for interim analyses as well as Data Monitoring Committee
• Quantitative pharmacoepidemiology design
• Statistical Analysis Plans (SAP)
• Developing Case Report Tabulations (CRTs)
• Integrated Summaries of Efficacy (ISE) and Integrated Summaries of Safety (ISS)

Regulatory Data Standards (CDISC) and Compliance

We are adequately aware of all regulatory body data standards that organizations need to comply with for clinical trial data submission. Qualified professionals will help in developing submission-ready and regulatory body-compliant:

• Data-ready SDTM and ADaM
• Study Data Standardization Plans necessary for device or drug developments
• Standard for Exchange of Nonclinical Data (SEND) as per CDISC standards

Report Writing

We develop and provide the following services to our global clients to assist in data submission with regulatory bodies:

• Study protocols and amendments
• Statistical reports
• Complete Clinical Study Reports (CSR)
• Statistical sections of the CSR
• Manuscripts
• Regulatory documents for meetings
• Promotional content for medical education

Statistical Consulting and Planning

We are capable of offering top-notch statistical planning and program-level consulting services for market-best statistical analyses and solutions. Our team works seamlessly to ensure our clients achieve success with their projects. We provide:

• Planning Clinical Development Plans and Target Product Profiles
• Critically assessing various phases of development
• Market Access Statistical Support
• Preparation and presentation for Regulatory Advisory committee
• Developing PK/PD strategy in a drug development program
• Planning necessary for global regulatory applications for NDAs, BLAs, ANDAs, PLAs, 505 b(2), PMA, and 510(k)

Clinical Trial: SDTM and ADaM

SDTM and ADaM are crucial models that are well-accepted worldwide for the submission of clinical trial data. We develop and validate CDISC-compliant, fully-documented SDTM and ADaM for our clients. Our team develops submission-ready:

• Annotated CRF
• SDTM specifications
• ADaM specifications
• Study Data Reviewer’s Guide and SDTM define.xml
• ADaM datasets connected to planned analyses
• Analysis Data Reviewer’s Guide and ADaM Define.xml

Statistical Programming

Our statistical programmers offer market-best statistical analysis and data management and deliver these services using beneficial statistical leads:

• Quality control listings and data management
• Regulatory-compliant and study-specific data sets
• Patient profiles and CRF tabulations
• Developing and validating figures, listings, statistical tables
• Validated macro libraries
• Statistical programming support for DSMB and DMC meetings

Statistical Programming

Our team provides world-class data management and statistical analysis. We offer:

• Regulatory-compliant and study-specific data sets
• Patient profiles and CRF tabulations
• Quality control listings and data management
• Validated Macro libraries
• Developing and validating figures, listings, statistical tables
• Statistical programming support for DSMB and DMC meetings

Challenges and Solutions

• Clinical trial data submission to the FDA and its approval is often a long, tiresome and sometimes challenging task. Any discrepancy or issues can straight away lead to rejection. Novartis reached out to us to facilitate hassle-free and quick trial data approval of its new drug for Myelogenous Leukemia, Gleevec or Imatinib.
• The FDA, as part of its review of clinical trial data, needs the organization to answer certain queries and questions. We assisted Novartis in the submission of appropriate responses with our top-notch post-hoc analysis.
• An accurately developed CSR is vital in the overall drug approval process. We also aided Novartis in developing FDA-compliant, submission-ready Clinical Study Reports for the drug in question.

Challenges and Solutions

• Roche collaborated with KnowTechInfo for its revolutionary drug Polivy which was designed to fight B-cell Lymphoma. Since clinical trial data submission is a crucial and complicated task, we assisted Roche in trial data submission to FDA for Polivy.
• During clinical trial data submission, the FDA puts forward multiple questions and queries as part of the scrutiny. KnowTechInfo, through its post-hoc analysis, aided in those queries. This was instrumental in faster approval.
• We carefully developed and validated FDA-compliant and acceptable Clinical Study Reports for the Lymphoma drug. A submission-ready and fully-documented CSR is crucial for drug approval. It summarizes the overall outcome of a clinical study to the FDA.

Core Outcome of the Project

• Improved Product Planning and Development: Novartis benefited from the integration of data science and statistical consulting services with respect to planning and developing fresh products in its pipeline. This allowed the pharma giant to streamline the drug and device development process.
• Quick Regulatory Approval: Our team assisted the organization in developing and validating regulatory body-compliant, fully documented and submission-ready SEND, SDTM, ADaM, etc, which helped it receive quicker approval of clinical trials data. This further accelerated the release of newer devices and drugs.
• Reduced Overall Costs: The inclusion of Biostatistics helped the company in efficient and faster decision-making that positively impacted its product planning and delivery. In a nutshell, the organization improved its production, delivery and overall operations without incurring additional costs. Novartis enhanced its R&D and pipeline in a smart and cost-efficient way by leveraging the power of big data.