Services and Expertise

·        Clinical service assessment and improvement--process, quality and performance

·        Translational research

o       Feasibility assessment

o       Research planning

o       Operations support

o       Regulatory planning, support and representation

o       Clinical advisory board management, participation

o       Safety and Quality review boards

o       Process review and bottleneck analysis and repair

·        Academic clinical trials organizations/networks—National, international

·        Health Systems, hospital networks

·        Industry contacts

·        Trials placement

·        Market sector analysis

o       Therapeutic area definition and sizing

·        Outsource providers

·        Contract research organizations

·        Site management organizations

·        Continuing medical education programs development and oversight

·        Information technology sources

·        Strategic information

·        Due diligence, independent third party review and assessments

·        Medical/Scientific specialists/consultants (as needed)

·        Professional services

o       "Large General Consulting Firms"

o       Boutique Consulting Firms

·        Business development

o       Small business start-up planning and advisory

o       Foreign sponsor support for FDA application

·        Pharma/Biotech sponsors

·        Tissue engineering specialists—scientific, legal, regulatory, medical

·        Trials contracting, accounting, tracking

·        Patient recruitment strategists

·        Market analysts, Polling Organizations

·        Customer satisfaction assessments

·        Clinical trials operations specialists

·        Quality assurance, Standard Operating Procedures (SOPs)

·        Process/performance metrics

·        Regulatory and legal review

·        Specialized personnel recruitment

o       Management

o       Staff (clinical and administrative)

Copyright: 2005