Biostatistics

• Clinical trial development plan

• Power/sample size estimation

• Statistical analysis plan

• Table shells

• Data mapping specs

• Randomization schedule

• Interim analysis

• ISS/ISE report

• Statistical report

• Bioinformatics services

Statistical Programming

• Development of SDTM/ADaM 

• TFL creation and validation 

• Programming support for patient profiles and patient narratives 

• Support for CSR, ISS/ISE, Interim 

• Support to regulatory, publication 

• Support database edit checks, query 

• Support of Data Monitoring Committee 

• Support exploratory analysis 

• Prepare e-submission package 

• CDISC implementation 

• Legacy data creation to SDTM 

• Annotating CRF pages 

• Define.pdf or Define.xml 

• Study data reviewer’s guide 

• Analysis Data reviewer’s guide 

• Submission of XPT datasets 

• Submission of programs 

• Final e-submission package

Medical Writing

• Protocols and amendments 

• Clinical Study Reports (CSRs) and patient safety narratives 

• Investigator brochure updates 

• Common technical document (CTD) overview and summaries 

• Integrated analyses of effectiveness (ISE) and safety (ISS) 

• Agency briefing packages 

• Informed Consent Forms (ICF) 

• Publications (abstracts, posters, manuscripts) 

• Submission-ready capabilities (electronic publishing): Fully hyperlinked and bookmarked documents

Regulatory

• Global Regulatory Strategies 

• Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.) 

• CMC (Chemistry, Manufacturing, Control) 

• Labeling 

• Translations of Technical Documents 

• Coordination of Regulatory Certificates