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