Our Services
We use EnCompass™ and experience to help you from start to finish
Years
Population
Purpose
Services
Preclinical Discovery Testing
6.5
Laboratory and animal studies
Assess safety, biological activity and formulation
– Identification / publication of patient-centered outcomes to strengthen trial design
– Market sizing and assessment
– Disease characterization
Phase I
Trials
1.5
Small sample, healthy volunteers
Determine safety and dosage
– Identification of key opinion leaders, caregivers, and patients
– Trial recruitment and qualification of potential trial sites / participants
– Disease education and support of diagnostic confirmation
– Medical / scientific and patient advisory boards
Phase II
Trials
2
Larger sample, patient volunteers
Evaluate effectiveness, look for side-effects
– Investigator meetings
– Patient advocacy, planning, and implementation
Phase III
Trials
3.5
Largest sample, patient volunteers
Confirm effectiveness, monitor adverse reactions
– Infrastructure planning
– Pre-launch testing and research
FDA
1.5
Review approval process
– Effectiveness measurements
– Medical education programs
– Compassionate allowance programs
Phase IV
Additional post-marketing studies required by the FDA
– Pharmacovigilance
– Expand diagnosis
– Consensus conference
– Expanding indications