InClin’s Biostatistics team works hand-in-hand with our Statistical Programming and Clinical Data Management teams to provide a wide range of services from protocol consulting, SAP development, randomization and IWRS development and more.
Our Biostatistics team provide global coverage for our sponsor’s statistical analysis needs with internal coverage across all time zones. With the help of our trusted partners, we can also provide local Statistical support in AUS.

Biostatistical Services

• Protocol development
• Determining Primary and Secondary Endpoints to maximize success probability
• Alpha Spending Scheme Planning
• Sample size calculation
• Statistical Analysis Plan
• Analysis methods development
• Regulator precedent review
• Developing Phase I, II and III integration plan for NDA submissions
• Developing ISS and ISE Statistical Analysis Plans
• Ad-hoc analyses
• Publications
• Randomization and IWRS development
• In-house Statistical support

Statistical Programming

InClin’s Statistical Programming team is made up collectively of experienced Senior Programmers with 8 to 40 years of experience in a range of therapeutic areas including (Autoimmune Disease, Cardiovascular, Dermatology, Endocrinology, Infectious Disease, Medical Device, Musculoskeletal, Neurology, Oncology, Ophthalmology, Phase 1 NHV, Rare Disease, Respiratory, Urology, Women’s Health). InClin’s Statistical Programming team seamlessly integrates with our Clinical Data Management, and Biostatistics to provide the full range of programming services from CDISC compliant data sets, TFLs, submission-ready packages and more.

Our Statistical Programming teams provide global coverage for our sponsor’s programming needs with internal coverage across all time zones. We can also provide Programming support in AUS via internal staff or through a trust partner, as needed.

Statistical Programming Services

• Developing SDTM and ADaM Specification and datasets per CDISC standards
• Define.xml files, Open CDISC report, Review Guide
• TLF programming
• Complex cross-tabular edit checks
• Data cleaning programming of key safety and efficacy endpoints
• Submission-ready package
• ISS and ISE Data Integration and Analyses
• Safety report and IB support
• Project reports

Biometrics

Our Biometrics Department is comprised of three key teams: Clinical Data Management, Biostatistics, and Statistical Programming. Collectively, they provide an integrated and comprehensive approach to clinical data capture, analysis, and presentation.

Our team is able to support both full-service and standalone opportunities, as well as Biometrics consulting. 

The InClin Advantage – What sets us apart?

• Technical Expertise — Trained professionals skilled at analyzing, synthesizing, and presenting data, allowing the client to focus on strategic review
• Comprehensive Experience — Our broad industry knowledge allows us to tailor our services to achieve each Sponsor’s specific goals
• Tailored Solutions — We work with a wide range of companies, from regional to global corporations, that have diverse products and development needs
• Proven Quality Processes — We use validated templates and quality reviews to produce high-quality deliverables that adhere to regulatory style guidelines
• Collaborative Environment — We work as an integral part of your team with the belief that we can achieve more together
• Resource Rich — We are flexible and can add resources to your team, as needed, to ensure that timelines are met, even as your project evolves

Additional Services

Regulatory Support

In addition, our Biometrics team collaborates seamlessly with regulatory and medical writing to provide the following services: 

• Strategic direction recommendations
• Briefing package preparation
• Regulatory agency meeting statistical discussion and presentation
• Regulatory submission-ready data, programming and analysis package
• Integrated summaries of safety and efficacy
• CSR statistical authorship
• New drug/device application and other report (eg, annual safety/IND reports) review and editing

Pharmacokinetics and Pharmacodynamics

InClin also works with a partner to support pharmacokinetics and pharmacodynamics analyses including:

• Non-compartmental analysis and reports using Phoenix WinNonLin
• Biomarker evaluation and analyses
• Relational analyses of the PKPD parameters to primary endpoints