Pediatric Clinical Research

Pediatric Clinical Research Services

Regulatory

  • Initial IRB Submission including consent forms and other required documents
  • Submit continuing reviews and modifications to IRB
  • IRB document maintenance
  • Negotiate with and serve as liaison between sponsors and IRB
  • Regulatory document management
  • Submit supplements and amendments to update registered product information
  • File and maintain correspondence with site and sponsor
  • Complete and email regulatory documents such as copies of medical licenses, CVs, etc to sponsors
  • Coordinate site initiation visits
  • Process confidentiality agreements and contracts
  • Manage study accounts
  • Assist with grant writing and manuscript preparation

Financial

  • Negotiate industry sponsored budget and start-up costs
  • Detailed financial reports
  • Financial tracking and billing
  • Billing Schedule, Research Rates, Industrial Account set-up
  • Submit invoices and reimbursements requisitions

Study coordination

  • Attend investigator meetings and teleconferences
  • Review protocols
  • Assess feasibility and patient population available for trial
  • Pharmacy Interface
  • Case report form completion ( paper and electronic)
  • Supervise monitoring visits
  • Onsite study recruitment, screening and enrollment
  • Collection, entry and maintenance of study data
  • Study close out and archives
  • Study recruitment and screening
  • Develop source documents and study specific SOPs
  • Process regulatory documents for study
  • Respond to queries
  • Coordinate and supervise Compliance and FDA audits
  • Provide in-services on study procedures
  • Maintain appropriate temperature logs

Routine research nursing services

  • Patient monitoring
  • Phlebotomy
  • Infusion studies
  • Pharmacokinetic studies
  • Anthropometric measurements
  • Urine collection studies
  • ECGs performed
  • Specimen processing, storage, and specimen shipping
  • Specimen retrieval from within the hospital
  • Custom labeling
  • Anthropometric measurements including skin-folds, BMI, etc.
  • Metabolic testing (resting metabolic rate) and Pulmonary function testing
  • Exercise stress testing (cycle ergometer or treadmill)
  • Muscle function testing
  • Bone densitometry
  • Advanced Cardiac Life Support
  • Monitoring of patients