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.
We are skilled at designing and implementing statistical methodologies for Phase I-IV clinical trials.
Our team of highly capable statisticians and programmers offers support for FDA and EMA submissions, including all CDISC datasets.
We provide un-blinded biostatisticians who present informative slides for DSMB or IDMC meetings to monitor safety and efficacy.
We possess broad analytic capabilities ranging from sample size calculations to integrated data analyses.
We are equipped to assume an advisory role for your regulatory submissions and respond to reviewer/rapporteur questions.
We co-author publications and provide statistical results and publication review.
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
Statistical Analysis Planning
- Analysis planning meetings
- Methodology development and evaluation
- Production of analysis plan/interim analysis plan
- Production of mock tables, listings and graphs
- 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
- Stand-alone statistical reports
- Integrated clinical study reports
- Tables, listings, graphs and statistical appendices
- Sponsor, FDA and conference presentations
- 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
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.
We thoroughly understand your study protocol and define a SAP & Programming Plan, including mock table shells.
Statistical programmers develop code to perform and produce specified analyses and reports.
Code reviews, independent validators and QC of output are performed to ensure results match intended analyses.
Comment tracking guarantees each comment received is resolved and appropriate actions are taken.
- Statistical programming for listings, tables and figures
- Integration of safety or efficacy databases
- SAS macro development for statistical methods or report generation
- On-site and off-site programming resources for individual studies or for every study
- Functional service provider contract to provide dedicated programming teams
- Dataset conversions to CDISC standards (SDTM, ADaM)
- QC and critical review of client analyses and reports
- Independent validation of statistical programming deliverables (reprogramming and review)
Clinical Data Management
Instat provides end-to-end clinical data management support for CRF design through database lock. From the start, we develop solutions with the end in mind, producing deliverables on time and on budget.
Quality, Submission-Ready Data
The Data Management team focuses on the development and maintenance of databases for a range of study types. Our approach is customized to each study's needs. Discover the ways Instat can partner with your team to provide clinical data management support:
- Data management planning
- CRF design and development
- Design, testing, validation and maintenance of eCRF study databases
- Edit check programming
- eCRF training and completion guidelines
- Data cleaning and reconciliation activities
- Ongoing support to study teams
- Web based randomization
- Coding of adverse events and medications
- Serious adverse event reconciliation between safety and clinical databases
- Database closeout
- Integrated Summaries of Safety/Efficacy (ISS/ISE)
- CDISC-compliant SDTM and ADaM data packages, including Define.xml, Reviewer's Guide and Additional Derivations documents
- OpenCDISC Validation (Pinnacle 21)
- Legacy Data Conversion
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)
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
We thoroughly understand your study protocol and analysis requirements, and define detailed SDTM and ADaM specifications.
Statistical programmers develop code to transform and map your project data to specified SDTM and ADaM domains.
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.
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