Roche

About the Client

Roche is a leading Switzerland-based multinational pharmaceutical organization that operates on two of its main divisions: pharmaceuticals and diagnostics. The organization is a pioneer in cancer and in-vitro diagnostics. It is also one of the largest biotech companies worldwide with a vast portfolio of medicines in immunology, oncology, ophthalmology, infectious disease and central nervous system diseases.

Roche has an illustrious past with more than 30 life-saving medicines on the list of World Health Organization Model Lists of Essential Medicines. The pharma giant continues on its journey to provide accessible, quality and cost-effective healthcare solutions to prevent, diagnose as well as treat diseases. It is also renowned to be one of the most sustainable pharma companies worldwide.

Some Revolutionary Roche Drugs

• Bevacizumab for eye diseases and cancer
• Trastuzumab for breast cancer
• Alectinib for lung cancer
• Tocilizumab for Rheumatoid Arthritis
• Cobimetinib for Melanoma
• Enfuvirtide for HIV/AIDS
• Polivy for high-grade B-cell Lymphoma

Client Details

Name: Roche Holding AG

Industry: Pharmaceutical

Geographic Location: Switzerland

Roche Partnered with us for:

Roche contacted us to avail of the following services:

Biostatistics

Biostatistical services include the following:

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

PK/PD Modeling and Simulation

At KnowTechInfo, our highly experienced team of experts use their expertise in PK/PD Modeling and Simulation to offer standalone PK/PD services or those integrated with Biostatistics:

• Developing PK/PD analysis plan
• Sparse Sampling Analysis
• PK and PK/PD analysis
• PK/PD report writing
• Toxicokinetics
• Population PK analysis
• Development of sub-studies as well as PK studies

Regulatory Data Standards (CDISC) and Compliance

Our experts are aware of the regulatory data science standards and FDA standards required for submission. We help in developing:

• Study Data Standardization Plans necessary for device or drug developments
• Standard for Exchange of Nonclinical Data as per CDISC
• Full-fledged, data-ready SDTM and ADaM

Clinical Trial: SDTM and ADaM

KnowTechInfo has the necessary expertise in developing CDISC-compliant SDTM and ADaM. We offer in developing:

• ADaM specifications
• SDTM specifications
• Annotated CRF
• Study Data Reviewer’s Guide and SDTM define.xml
• Analysis Data Reviewer’s Guide and ADaM Define.xml

Report Writing

Professionals at KnowTechInfo assist in creating the following to help businesses in data submission:

• Study protocols and amendments
• Complete Clinical Study Reports
• Statistical sections of the CSR
• Statistical reports
• Manuscripts
• Regulatory documents for meetings
• Meeting preparations

Statistical Consulting and Planning

As part of Statistical consulting and planning, we offer world-class services and assistance for:

• Planning and researching for Clinical Development Plans and Target Product Profiles
• Assessment for different phases of development
• Market Access Statistical Support
• Development of PK/PD strategy in a drug development program
• Support, representation and preparation for the Regulatory Advisory committee
• Planning for global regulatory applications for NDAs, BLAs, ANDAs, PLAs, PMA, 505 b(2) and 510(k)

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

Training and Development

Our training and development services include tailored services for every organization in different fields, such as:

• Regulatory data science
• SDTM and ADaM basics
• Statistics for non-statistician
• Design and analysis of clinical trials

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

• Increased Operational Efficiency: The inclusion of biostatistics and other integrated services enabled the organization to leverage the potential of data science to streamline and improve operations, planning, production, clinical trials, data submission and release of new products.
• Cost Reduction: With the incorporation of data management and integrated data science technology, the overall operations expenses of the company have been successfully reduced.
• Faster Approvals: Streamlined data submission for clinical trials in accordance with regulatory body guidelines has encouraged smoother and more efficient trial approvals that have further facilitated the accelerated release of products.