Therapeutic Areas

 

    Cardiac Disease
         • Arrhythmias
         • Hypertension
         • Atherosclerosis
    Inflammation 
         • Rheumatoid Arthritis
         • Osteoarthritis
    Oncology
         • Chemotherapy-induced emesis
    Women’s Health
         • Osteoporosis
         • Women’s Cardiovascular
    Nutraceuticals

 

 

    Phases I through IV
    Planning, advising and writing of clinical protocols 
         • Study design
         • Comparator, Placebo, Open Label, etc.
         • Parallel, Crossover
    Sites 
         • Identification and evaluation criteria
         • Site initiation
         • Site Aids
    Investigators’ Meeting logistics, design and presentations
         • Critical acclaim
               - Thorough
               - Accurate
               - Ingenious
    Study dynamics and tracking: Faster, more accurate
         • Electronic Data Capture 
         • Telerandomization 
         • Design of Case Report Forms, Informed Consent Documents, Support Documents and Aids
    Adverse Event and Serious Adverse Event evaluation and decisions

 

 

    Life-cycle management
    Planning of appropriate trials for Go/No Go decisions early
    Program / project planning and management
    Drug Supply Issues
    Regulatory input
         • Supplying medical efficacy and safety data for NDA submissions

 

Cross Functional expertise within Matrix Organization

 

    Preparation of database 
    Final roll out for Clinical Study Reports (CSR) and publications
    SAP
    Marketing and Sales force
    OR
    Writing
    International support
    Publications

 

 

 

    Communication
    Respect for Diversity
    Medical Professionalism
    Teamwork
         • When the team succeeds, everyone looks good, not just one individual
         • Communication

 

 

    Steering Committee 
    Advisory Committees
    Communication
    International Uniqueness

 

 

    Manuscripts
    Abstracts
    Congress presentations
    Postings: Federal web requirements 

 

 

    Strategic alignment

 

 

    Studies
    Sales force presentations
         • Correct Data Evaluation
         • DTC - DDMAC
    Continuing Medical Education Presentations
    Package Insert 
    Congress Booth poster presentations

 

 

    Doctor-to-Doctor presentation kits for:
         • Cardiovascular
         • Rheumatology
         • Women’s Health (CV specific)

 

 

    Major Support in phase IV
    Create critical real world, phase IV data

 

 

 

 

    Research the proposal
    Play it out / sounding board
    Re-research the proposal
    Be ready to take it up the ladder

 

 

    Evaluation above average