Project Management

  • Dedicated project manager focusing on the management and administration of the clinical trials

  • Peace of mind project management service for the client

 

Site Management

  • Site management

  • Subject recruitment and management
  • On-site monitoring

Data Management Services

  • Case report form (CRF) design

  • Database design, build, and validation
  • Extensive edit checking
  • MedDRA and WHODrug coding
  • Data cleaning with query management
  • Data integration from all sources (vendors)
  • Patient profiles
  • Data dashboard building for quick data quality review

 

Statistical Programming

  • CSR submission support

    • CDISC SDTM-IG compliant datasets

    • CDISC ADaM-IG compliant analysis datasets

    • Tables, figures, and listings (TFL)

    • Integrated summary of safety (ISS)

    • Integrated summary of efficacy (ISE)

    • Standard datasets submission packages

  • Standard agency reporting

  • Regulatory safety report (DSUR, IB)

  • IDMC/DSMB services: two-team (blinded/unblinded) reporting, idmc chart, blinding plan, executive summary

  • Patient profile and patient narratives

  • Randomization scheme production

Biostatistics Services

  • Novel advanced clinical design (frequentist and bayesian) across all clinical trial phases
  • Simulation of clinical design across all clinical trial phases
  • Power and sample size calculations
  • Statistical modeling
  • Big data analysis
  • Statistical analysis plan (SAP) development
  • Statistical input for publication
  • Agency interaction from biostatistical standpoint

Medical Writing

  • Protocol development
  • Clinical study report (CSR) authoring
  • Ad-hoc study report

On-Site Inspection Support

  • Inspection Preparation

  • Inspection findings explanation and resolving

Pharmacovigilance

  • Adverse event report collection, entry, reporting
  • Submission of rapid safety report (SUSAR)
  • Literature search of adverse events
  • All safety related writing/reporting
  • Drug risk management Plan (RMP) formulation and implementation

Clinical Lab Services

  • Lab service to support clinical trial

  • Clinical chemistry, hematology, immunology, microbiology

  • Lab data dashboard for signal detection