Regulatory Affairs |
- Regulatory strategizing from pre-clinical through Phase IV
- Interpretation of FDA/ICH regulations and guidance
- Planning and facilitation of Advisory Committee meetings
- Preparation of FDA Advisory Committee materials |
- Preparation of FDA pre-meeting materials
FDA liaison meeting facilitation
- Critical review of regulatory reports and documents
- Preparation and submission of regulatory documents (including INDs, NDAs, and SNDAs)
- Preparation and submission of annual reports |
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Medical Writing |
- Clinical protocols
- Summary sections of INDs and NDAs
- FDA pre-meeting packages
- Advisory Committee meeting briefing documents |
- Integrated summaries of efficacy and safety
- Regulatory strategy documents
- Integrated clinical study reports
- FDA meeting minutes |
|
Data Management |
- CRF design
- Database design and programming
- Data coding |
- Validation
- Query management
- Data archiving |
|
Project Management |
- Investigator site selection
- Investigator grant negotiation and payment
- Study coordination
- Budget and timeline management |
- Communication management
- Detailed clinical review
- Oversight of CRAs and project team |
|
Medical Monitoring and Safety Management |
- Around-the-clock, continuous physician coverage
- Serious Adverse Event (SAE) processing |
- SAE narratives, MedWatch, Analysis of Similar Events (AOSE)
- Protocol-related interactions with Investigators |
|
Clinical Monitoring |
- Site qualification
- Regulatory documentation collection
- Site initiation
- Interim site visits |
- Query management
- Site close-out
- Overall site management |
|
Biostatistics |
- Optimal clinical trial study designs to meet regulatory and promotional needs
- Statistical analysis support for studies conducted at all stages of drug research, development, manufacturing, and marketing
- Assistance in presenting statistical methods before regulatory authorities
- Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, animal studies, clinical development, evaluation/approval, manufacturing, and marketing research |
- Full support for Phase I-IV clinical trials
Study design and consultation
- Assistance with protocol development and verification of CRF design
- Analysis plan development
SAS programming for tables, figures and listings
- Interim analysis/DSMB
- Regulatory and advisory meeting support |
