GlaxoSmithKline USA

About the Client

GlaxoSmithKline is a widely renowned global biopharma organization focused on combining talent, science and technology to bring a positive impact on global health. The company is involved in vaccine R&D bringing in new vaccine technology as well as working on developing a new and differentiated pipeline of consumer healthcare products.

It is also heavily invested in drug discovery and development in multiple key areas of interest, including Oncology, Neuroscience, Ophthalmology, Neglected Tropical Diseases, Immuno-inflation, Bioelectronics and many others.

Some Revolutionary GSK Drugs

• Advair for Asthma and COPD
• Nucala for Asthma
• Benlysta for Lupus
• Tykerb for hormone-related Breast Cancer
• FluLaval for Influenza
• Triumeq for HIV

Client Details

Name: GlaxoSmithKline

Industry: Pharmaceuticals

Geographic Location: USA

GlaxoSmithKline Partnered with us for:

GlaxoSmithKline connected with us to avail of the following services:

Biostatistics

At KnowTechInfo, our team of highly qualified Biostatisticians are skilled at offering world-class Biostatistics services, including:

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

PK/PD Modeling and Simulation

We are proficient in offering best-in-class PK/PD Modeling and Simulation. Our professionals can offer both standalone PK/PD services or services that are integrated with Biostatistics:

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

Clinical Trial: SDTM and ADaM

Qualified professionals at KnowTechInfo can develop CDISC-compliant SDTM and ADaM for our clients. We offer developing submission-ready:

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

Regulatory Data Standards (CDISC) and Compliance

Experts at KnowTechInfo understand the regulatory data science standards and FDA standards that individuals and organizations require for submission. Our team will help in developing the following:

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

Report Writing

Data submission with compliance to regulatory body standards is an integral part of getting approvals for drug or device development. We will assist in developing high-quality:

• Study protocols and amendments
• Statistical sections of the CSR
• Any kind of promotional content for medical education
• Complete Clinical Study Reports
• Statistical reports
• Manuscripts
• Regulatory documents for meetings
• Meeting preparations

Statistical Programming

Skilled in providing SAS software programming, we offer exceptional data management and statistical planning to a wide range of our clientele. Our robust team of statistical programmers can offer a vast range of services, including but not limited to the following:

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

Statistical Consulting and Planning

Along with top-quality analyses, we combine exceptional statistical solutions to assist our clients throughout drug development programs. Our experts offer superior statistical consulting and planning services for:

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

Training and Development

In addition to providing data science services, we aim to help our clients get an idea of the statistical and data science services and their importance in clinical trials. Our renowned experts offer training on:

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

Challenges and Solutions

• Clinical data trial submission is a long, tedious and often complicated process. Any error could potentially lead to rejection by the FDA. KnowTechInfo assisted GSK in hassle-free submission of trial data for Tykerb, a breast cancer drug developed by the organization.
• During trial data submission, FDA conducts a scrutiny that includes the regulatory body raising multiple questions or queries. We assisted GSK to successfully fill out these queries through post-hoc analysis that accelerated the approval.
• KnowTechInfo developed two customized software, namely Drug Supply Modeling and Optimal Design. The Drug Supply Modeling software predicts the proper supply of drug needed to cover patient demand in a single study with the risk of drug running out for one patient. The Optimal Design software helps to identify the appropriate dose-finding strategies for drug development.
• CSR or Clinical Study Reports are a crucial part of applications sent to regulators for new medical treatments. We assisted GSK to develop CSR for the above-mentioned drug.

Core Outcome of the Project

• Cost Reduction: With the successful incorporation of data science, statistical planning, consulting and programming services, the organization managed to improve its drug and device development while reducing the overall operational budget. The Drug Supply Modeling Software helped GSK save $1 billion.
• Increased Production: Our world-class data science and Biostatistics services enabled the organization to utilize the power of big data. GlaxoSmithKline USA successfully streamlined its product planning, research and development, clinical trials, data submission and release of products.
• Improved R&D: World-class statistical planning, consulting, programming, and other integrated services helped the company to fast-track research and development for new and improved products. The Optimal Design software played a vital role in research and development of Tykerb.
• Smoother Regulatory Approval: We assisted our client with data submission of clinical trials to multiple regulatory bodies in compliance with the data standards as laid down. This allowed GlaxoSmithKline to receive faster and hassle-free approvals.