Johnson & Johnson

About the Client

With an illustrious past of 135 years, US-based Johnson & Johnson is the world’s largest and one of the most diversified consumer healthcare product manufacturers. The organization boasts a wide portfolio of consumer healthcare items, prescription and pharmaceutical products and medical devices/diagnostics products.

The organization has been consistently striving to provide accessible and affordable healthcare solutions worldwide for a vibrant and healthier global community. As per the organization’s official website, it is focused on developing world-class products to help every individual stay healthy at every stage and every age.

Some Revolutionary Johnson & Johnson Drugs

• Topamax for Epilepsy
• Imbruvica for Leukemia
• Razadyne for Alzheimer’s
• Edurant for HIV/AIDS
• Concerta for Attention Deficit
• Teclistamab for Refractory Multiple Myeloma
• Invokamet for Diabetes

Client Details

Name: Johnson & Johnson

Industry: Pharmaceutical

Geographic Location: US

Johnson & Johnson Partnered with us for:

Johnson & Johnson connected with us to avail these services:

Biostatistics

As part of our Biostatistical services, experts at KnowTechInfo are experienced in providing the following services for clinical trials, drug and device development:

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

Regulatory Data Standards (CDISC) and Compliance

Professionals at KnowTechInfo are proficient with all regulatory data standards and FDA standards that organizations need to comply with during clinical trial data submission. Our team assist in developing submission-ready, full-fledged and regulatory body-compliant:

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

PK/PD Modeling and Simulation

At KnowTechInfo, we offer extensive services and support for PK/PD Modeling and Simulation. PK/PD is highly crucial for drug development as well as approval. Our team is qualified to provide both standalone PK/PD or integrated services with Biostatistics:

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

Clinical Trial: SDTM and ADaM

SDTM and ADaM are two widely accepted models for clinical trial data submission. These are compliant with CDISC standards. KnowTechInfo has the necessary expertise in developing CDISC-compliant, fully-documented SDTM and ADaM. We develop and validate:

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

Statistical Consulting and Planning

We understand the importance of statistical services in clinical trials as part of drug or device development. Our experts are equipped with vast experience and can offer world-class statistical consulting and planning. Our services and assistance are aimed for:

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

Statistical Programming

With vast experience in SAS software programming, we are proficient in providing top-notch data management and statistical planning. The statistical programmers at KnowTechInfo can offer a vast range of services, including:

• 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

Report Writing

Proficient in data standards and compliance rules for clinical data submission, our experienced team can develop and provide the following to assist in data submission with various regulatory bodies:

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

Training and Development

Our training and development services include tailored services for every organization in different fields. Our highly accomplished professionals can provide top-notch training to help our clients understand the importance of our services. We offer the following:

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

Challenges and Solutions

• Clinical trial data submission and approval is a tedious and complicated process. Pharmaceutical organizations need to be careful, as any error or discrepancy could lead to outright rejection by the FDA. At KnowTechInfo, we assisted Johnson & Johnson in submitting FDA-compliant trial data for its B-cell lymphoma drug Teclistamab.
• After submission of trial data, the FDA conducts stringent scrutiny in which the organization seeking trial data approval is obligated to answer certain queries and questions. Our team at KnowTechInfo helped in the submission of replies to those questions through intense and accurate post-hoc analysis.
• Clinical Study Reports are an essential part of the application for new drug approval. KnowTechInfo prepared the CSR for Teclistamab trial data approval to facilitate hassle-free approval.

Core Outcome of the Project

• Improved Operational Efficiency: Leveraging the true potential of big data, data science management and Biostatistics, we helped the organization streamline its product development and release of new products.
• Faster Clinical Data Trial Approval: The inclusion of our statistical consultation and software programming, biostatistics and other regulatory body-compliant integrated services allowed the organization to receive hassle-free approval of clinical trials for multiple drug and device development.
• Cost-efficiency: Our team successfully helped the organization in taking smart data-enabled business decisions that helped it to automate its planning and production. This allowed us to improve the overall operations while slashing associate costs.