- We understand the importance of time and accessibility. We offer accessibility and expertise in making critical decisions when they are needed most, not just during normal business hours. That’s why 24 hours a day, 7 days a week via phone and rapid response email you will find a representative available to assist you.
- We provide A-Z services under a single Umbrella.
- In- depth therapeutic experience in all major and narrow therapeutic areas.
- Highly experienced project management team
- Focused on details
- Cost effective, flexible and dependable services
- Commitment of quality
- Maintain timelines effectively
- Strategic Planning and communication
- Commitment to employee growth and retention
- Innovative Leadership
- Believes in being a research partner and not a vendor or contractor.
- Large pool of investigators all all therapeutic indications
- Having experience in almost every therapeutic indication including vaccine studies
- We believe our experience and expertise can build knowledge and our knowledge can build value to our services
- Clinical development planning
- Regulatory consulting
- Protocol design
- Expert panels
- First introduction into man
- PK/PD studies
- Single-dose, multiple-dose, and dose-escalation studies
- Special studies (e.g. food interaction; skin irritation)
- Proof-of-concept studies
- Dose-ranging studies
- Large-scale global safety and efficacy studies
- Placebo-controlled studies
- Active-comparison studies
- Bioequivalence studies with clinical endpoints
- Quality-of-life studies
- Resource utilization studies
- Individual study reports
- Integrated safety and efficacy summaries
- Treatment INDs
- Package inserts
- Submissions in NDA or CTD formats
- Post-approval regulatory commitments/support for primary indication
- New indication studies/labeling expansion
- Medical Information & Professional Contact Center
- Registries and Observational studies
- Health-related quality of life, patient-reported outcomes via IVRS
- Post-marketing surveillance
- Product Safety and Pharmacovigilance
- Retrospective chart reviews
- Managed-care studies
- Pharmacoeconomics
