Services Overview

Biostatistics

Statistical Programming

Regulatory Submissions

CDISC Datasets

Medical Writing

Services Overview

Instat provides a range of specialized biostatistics services for small and large pharmaceutical, medical device and clinical research companies. Our goal is to provide a customer-focused experience tailored to supporting your projects.

Design

We are skilled at designing and implementing statistical methodologies for Phase I-IV clinical trials.

Support

Our team of highly capable statisticians and programmers offers support for FDA and EMA submissions, including all CDISC datasets.

Present

We provide un-blinded biostatisticians who present informative slides for DSMB or IDMC meetings to monitor safety and efficacy.

Analyze

We possess broad analytic capabilities ranging from sample size calculations to integrated data analyses.

Advise

We are equipped to assume an advisory role for your regulatory submissions and respond to reviewer/rapporteur questions.

Review

We co-author publications and provide statistical results and publication review.

Biostatistics

Instat’s biostatisticians have the depth of experience to provide scalable solutions. Our qualified professionals offer individual support to advance your clinical drug trial. Here’s how our biostatisticians work as part of your team:

Statistical Aspects of Study Design

  • Protocol development/Experimental design consulting
  • Sample size/Power calculations
  • CRF review
  • Randomization

Statistical Analysis Planning

  • Analysis planning meetings
  • Methodology development and evaluation
  • Production of analysis plan/interim analysis plan
  • Production of mock tables, listings and graphs

Data Analyses

  • Specification and programming analysis derived datasets
  • Analysis dry run
  • Formal interim and final analyses
  • Post-hoc and exploratory analyses
  • Blind review of protocol violations
  • ISS/ISE analysis

Reporting

  • Stand-alone statistical reports
  • Integrated clinical study reports
  • Tables, listings, graphs and statistical appendices
  • Sponsor, FDA and conference presentations

Statistical Consulting

  • Consulting on statistically related regulatory issues
  • Abstract and publication analysis and writing
  • Data analyses and support for clinical publications
  • Serve as unblinded biostatisticians and as members of data monitoring committees and Data Safety Monitoring Boards
  • Interface with regulatory authorities

Statistical Programming

Instat assigns experienced statistical programmers, each with at least a Master of Science in Statistics, for all projects. With superior skills in SAS programming for clinical trials, our programmers protect the integrity of your data. Our expert programmers follow Instat’s streamlined, four phase process to ensure the highest quality deliverables.

How we do it

Our success is in the details. Follow our four-phase process and see how our efficient and effective method will work for you.

Four-Phase Process

Phase 1

Specifications

We thoroughly understand your study protocol and define a SAP & Programming Plan, including mock table shells.

Phase 2

Development

Statistical programmers develop code to perform and produce specified analyses and reports.

Phase 3

Validation

Code reviews, independent validators and QC of output are performed to ensure results match intended analyses.

Phase 4

Client Review

Comment tracking guarantees each comment received is resolved and appropriate actions are taken.

Programming Offerings

  • Statistical programming for listings, tables and figures
  • Integration of safety or efficacy databases
  • SAS macro development for statistical methods or report generation
  • SAS interface to Oracle Clinical
  • On-site and off-site programming resources for individual studies or for every study
  • Dataset conversions to CDISC standards (SDTM, ADaM)
  • QC and critical review of client analyses and reports
  • Independent validation of statistical programming (reprogramming and review)

Regulatory Submissions

Instat’s biostatisticians and programmers have direct experience in data conversion to CDISC for FDA submissions, integrated data analyses for efficacy and safety, clinical study report data and in NDA, MAA, BLA and other submissions.

Depth of Experience

Instat’s biostatisticians have collectively worked on over 30 submissions to various regulatory agencies, including the FDA, EMA, Canada Health, Swissmedic, and the PMDA and MHLW in Japan. Instat has participated in numerous NDA orientation and FDA meetings, as well as meetings for the Oncologic Drugs Advisory Committee (ODAC). The 30 submissions break down as follows:

  • NDAs: 19 collectively (8 unique)
  • 15 received first cycle approval (6 unique)
  • 5 had priority review, all leading to approval (3 unique)
  • 4 received orphan drug status, all were approved (2 unique)
  • Submissions outside the US: 11 collectively (8 unique)

CDISC Datasets

Sponsors are looking to CROs to help convert studies to SDTM and ADaM standards in anticipation of their products qualifying for submission to the FDA. Instat’s experts can complete this complex and time consuming process efficiently and at a lower cost.

How we do it

We've developed a programming methodology along with spreadsheets and SAS macros that streamline the conversion of your study data. It covers the entire process from mapping specifications to SAS programming to a well-documented define.xml.

CDISC Development Process

Phase 1

Specifications

We thoroughly understand your study protocol and analysis requirements, and define detailed SDTM and ADaM specifications.

Phase 2

Development

Statistical programmers develop code to transform and map your project data to specified SDTM and ADaM domains.

Phase 3

Validation

Code reviews, independent validators and QC of output are performed to ensure results match intended dataset specifications, and industry standard validator tools are used to ensure compliance.

Instat's proven success

Working as trusted partners with our clients, we have performed many important CDISC conversions that subsequently helped our clients’ products get approved and to market. Here are a few recent examples:

  • Submission 1
    • We created compliant study-level SDTM datasets for 3 legacy Phase I studies from a proprietary data management system.
    • We designed and created an integrated safety summary (ISS) database in ADaM format, from which all ISS analysis tables were produced.
  • Submission 2
    • We converted two pivotal Phase III studies to SDTM and ADaM as well as ISS ADaM datasets.
  • Submission 3
    • We converted 18 legacy studies to SDTM standards.
    • We performed ISS data analysis using pooled ADaM datasets created by Instat.

Medical Writing

Our efficient and committed medical writers can help you through your submission and approval process.

Documents and Submissions Supported

  • NDA, MAA, NDS, PMA, 510(k): Initial and all forms of lifecycle
  • IND, IMPD, IDE: Initial and all forms of lifecycle
  • Clinical study protocols and reports (CSRs)
  • Clinical study report appendices
  • Case report forms (CRFs)
  • Define/CRT documents
  • Investigator Brochures (IBs)
  • Briefing/meeting packages
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