Biostatistics & Programming 

InClin’s Biostatistics team is made up of highly skilled Statisticians with an average of 20+ years of experience in a range of therapeutic areas including: Autoimmune Disease, Cardiovascular, Dermatology, Endocrinology, Infectious Disease, Musculoskeletal, Neurology, Oncology, Ophthalmology, Phase 1 NHV, Rare Disease, Respiratory, Urology, Women’s Health. InClin’s Biostatistics team works hand-in-hand with our Statistical Programming, Clinical Data Management, Clinical Operations, and Sponsor teams to provide a wide range of services from protocol consulting, SAP development, randomization and IWRS development and more.

Our Biostatistics team provides global coverage for our sponsors’ statistical analysis needs with internal coverage across most time zones.

Biostatistical Services

• Protocol development and review
• Sample size calculation
• Randomization and IWRS development
• Statistical Analysis Plan
• Analysis methods development
• TFL review and QC
• Ad-hoc analyses
• Publications
• DSMB statistical support
• Interim analyses planning and statistical support
• Safety report and IB support
• CSR review
• Developing ISS and ISE Statistical Analysis Plans

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
• TFL 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 US and Australia-based senior 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

• Proven Quality Processes — We use quality reviews to produce high-quality deliverables that adhere to regulatory guidelines
• Our standard is independent double-programming for data sets for SDTM, ADaM, and TFL programming to ensure accurate data and data summaries
• Statistical QC of TFLs is also conducted

• 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 has experienced Phase 1 Statisticians who develop protocols and Statistical Analysis Plans. We also have template SAPs and TFLs for PK analyses.

In addition, InClin also has experienced staff and contract pharmacokineticists to support PK/PD analyses including:

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