Medical Writing
- Protocol and synopsis
- Informed consent document
- Investigator Brochure
- Clinical Study Report
- Manuscripts for publication
- Regulatory documentation filing (IND, NDA etc.)
Medical Monitoring / Data review or cleaning
- Develop study specific clinical data quality review plan and provide training to study team
- Provide guidance on query wording
- Develop medical monitoring plan (distinct from data review/cleaning)
RECIST v1.1 / iRECIST Training
- RECIST v1.1 Training for Sites and Study Personnel
- Study Specific RECIST Training Slide Development (includes practice cases)
- Aligns with eCRF Development
Development of key clinical trial documents
- Pharmacy manual
- Informed consent
- Medical monitoring plans
- Protocol deviation plans
- CRF completion guidelines etc.
Clinical Trial Operations
Scientific Support
- Provide clinical science expertise to clinical operations group and cross-functional teams
- Train clinical site personnel (investigator, study coordinators), CROs on therapeutic area, compound and clinical study protocol
- Serve as scientific resource for addressing or resolving issues during clinical study conduct
Contract Staffing and
Direct Hire
- Hourly recruiting assistance / project based work hiring on an as needed basis
- Provide flexible short and long-term contract staffing solutions
to meet client project deliverables
- Provide direct hire/executive search services for permanent candidates
