Our Services

We use EnCompass® and experience to help you from start to finish

Years

Population

Purpose

Our 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