Lanikai Research Consulting, LLC
Pharmaceutical Research
Services
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Protocol Development and Writing
 
Project Management for Phase I-IV programs
                Investigator recruitment
Investigator evaluation and qualification program
Regulatory document preparation and tracking
FDA, ICH, and GCP educational presentations
Investigator and Site training
Protocol specific source document templates (diaries, detailed flow sheets etc.)
eCRF and paper CRF creation
Creation of newsletters for communication with sites
Investigator Meeting
Presentations
Materials preparation and support
Site Monitoring
US, Japan and Canada coverage
Experienced in target therapeutic areas
Specialized, dedicated, certified
Can meet emerging needs (unexpected, mid-project or during peak workloads)
 
Patient Recruitment and Retention Strategies
Flyer and mailer creation
Conception, creation and full production of radio, television and print ad campaigns
Web site creation
Innovative retention tactics
 
 Audits
Data validation
Site
IRB
 
Data Management
EDC
Double blind data entry
Data Validation
21 CFR part 11 compliant
 
Vendor Procurement and Management
Laboratory
Contracted vendors
Support Services

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