Allergan

About the Client

Allergan is a leading pharmaceutical company involved in developing and manufacturing drugs, biosimilars and medical devices. The products that Allergan offers are in the field of dermatology, medical aesthetics, eye care, urology, women’s health, central nervous system, anti-infective therapeutics and gastroenterology.

This specialty pharmaceutical organization has a world-class research and development (R&D) program to help develop life-saving products to revolutionize the standard of healthcare. Moreover, Allergan has a rich and promising pipeline of new therapeutics and innovative technologies aimed at providing novel therapies that can bring a paradigm shift to treatment and healthcare.

Some Revolutionary Allergan Drugs

• Bystolic for Hypertension
• Restasis for Rheumatoid Arthritis
• Ozurdex for Glaucoma
• Namzaric for Alzheimer’s
• Namenda XR for Alzheimer’s
• Botox for cosmetic purposes to remove glabellar frown lines

Client Details

Name: Allergan

Industry: Pharmaceuticals

Geographic Location: US

Allergan Partnered with us for:

Allergan collaborated with us for the following services:

Biostatistics

Biostatistics plays a vital role in new product development and clinical data trials. At KnowTechInfo, we have a team of highly qualified biostatisticians who are skilled in offering curated biostatistics services, including the following:

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

Clinical Trial: SDTM and ADaM

We have the necessary skill to develop full-fledged, submission-ready CDISC-compliant SDTM and ADaM for our clients that can assist in making clinical trial data submissions and facilitate faster approvals. We offer developing submission-ready:

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

Regulatory Data Standards (CDISC) and Compliance

To receive faster and hassle-free approval of clinical trial data, it is essential to be aware of all regulatory body compliance standards. Accomplished professionals at KnowTechInfo will help in clinical trial data approval by developing submission-ready:

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

Statistical Programming

With knowledge and expertise in SAS software programming, professionals at KnowTechInfo use statistical analysis and data management to deliver:

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

Statistical Consulting and Planning

KnowTechInfo offers world-class statistical analyses and solutions for drug development programs. Here, we leverage the potential of Biostatistics for:

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

Challenges and Solutions

• Allergan approached KnowTechInfo for FDA data submission and approval for whether Botox (Botulinum toxin-A) could be used for treating chronic migraine and urinary incontinence. FDA trial data submission is a tricky and cumbersome procedure. We assisted in the overall data submission to FDA and facilitated smooth approval.
• The FDA requires each organization seeking drug approval to respond to queries as part of safety scrutiny. We helped Allergan frame and submit appropriate responses for these questions.
• Fully-documented Clinical Study Reports summarize the trial outcome. It plays a vital role in drug approval. KnowTechInfo developed FDA-compliant submission-ready CSR for this case.

Core Business Impact

• Quicker Regulatory Approval: With our expertise and skill, we have helped in developing regulatory body-compliant ADaM, SDTM and SEND. This assisted the pharma giant in receiving approvals for clinical data in a more efficient way, which accelerated its product development and delivery.
• Streamlined Product Development: Our top-notch statistical analyses, planning, consulting, and data science services helped the company to leverage the power of big data. It enabled product planning, development and release to be hassle-free, smooth and highly streamlined.
• Reduced Cost: Allergan was able to improve its research and development and fastrack its product development and release in a smart and cost-effective way. With data science and statistical services from us, the pharma giant enhanced its operational efficiency with respect to particular drug development cycles while reducing expenses.