Shaping Study Decisions &Uncovering Insights
Guided by over 25 years of biometrics expertise, Advanced Clinical delivers comprehensive, results-driven Data Management, Technical Programmer, Medical Coding, Biostatistics and SAS programmer services that enable sound data-driven decisions. With our broad base of expertise and integrated analyses, we’re equipped to address the most rigorous timelines and the most complex data integrations, ultimately reducing the time to regulatory submission.
Clinical Biostatistics Services
- DSMB/DMC and Clinical Events Committee support
- Statistical analysis plans
- Protocol, case report form and clinical study report review
- Randomization schedules
- Planning and implementing interim analyses
- NDA: Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
- FDA and other regulatory interactions, including Advisory Committee meetings
- Publication support and ad hoc analyses
- Statistical consulting
SAS Programming Services
- CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
- Experience with multiple EDC platforms
- Derived data set production and validation
- TLF production and validation
- Regulatory submissions (development of integrated ADaM data sets for ISS/ISE analyses, Define.XML)
- Submission-ready data sets and programs
- Study rescue and legacy data requests
Data Management
We use years of experience, a solutions-oriented approach and leading-edge technology to help you achieve faster study startup, shorter time to database lock and a better overall experience. Along with our time-tested and industry-proven SOPs, wide range of electronic data capture (EDC) systems and experience with electronic diaries and ePRO, we work closely with you to gain insights and provide recommendations based on the size, scope and complexity of your trial.
