SERVICES
a list of the professional
services we offer

Single Site

  • Complete project management
  • - Develop and manage site contract, budget and   timelines
  • Develop recruitment strategies
  • Subject/patient randomization
  • - Electronic or envelope based
  • Medical oversight
  • - Medical monitoring (e.g., subject/patient eligibility   review, exemption requests)
  • - Safety review (SAEs and data listings)
  • - Capsule summary writing
  • - External safety monitoring board (if needed)
  • Pharmacokinetics
  • - Bioequivalence and bioavailability trials
  • Cantara owned and operated CAP and CLIA    accredited laboratory services
  • Cantara owned serum and tissue banking     (e.g.,sample storage for pharmacogenomics     resistance testing)
  • SAE reporting - to the sponsor and/or directly to    FDA and ethics committees
  • Data management/quality

- CRF development (paper or electronic)

- User acceptance testing


- Listings review

- Database cleaning and lock

  • Drug supply management

- Packaging and label design

- Blinding subcontracting

- Randomization

  • Trial monitoring

- Trial site identification, qualification visits    and selection

- Initiation visit

- Interim monitoring visits

- Metrics report generation (e.g., enrollment    projections and actuals)

- Close-out visit
- Site audits

  • Statistical analyses
  • - Randomization code generation
  • - Sample size calculation/trial power
  • - Post study analyses
  • Clinical study report - write or review
  • Scientific submissions - abstracts and     manuscripts

Multiple Sites

  • All services listed under "Single Site"
  • Additional Services:

- Manage project contracts, budgets, timelines, and    IRBs/IECs

- ECG reading (central reading services)

- Plan and conduct Investigators' Meeting and   training of site personnel

Scientific Services

  • Conduct and moderate scientific advisory boards for     protocol development and publication planning
  • Develop drug life cyclemanagement strategies
  • Medical writing services
  • Create and maintain trial data registries
to learn more about our services