The only full-service dermatology CRO that takes products from concept to approval

Clinical Operations, Regulatory Affairs & Data Management

CRO Services | Product Development Planning

Clinical Operations

The clinical operations team initiates and manages clinical studies as described in the General Investigational Plan.

Clinical Development Project Management

  • Develop project timelines and budgets
  • Track and manage weekly project progress
  • Develop and maintain sponsor communications to ensure sponsor awareness of project progress
  • Set up and maintain project files

Medical Monitoring

  • 24 hours/7 days per week medical monitoring
  • Site support for protocol subject qualification and medical needs
  • Experienced SAE handling and processing

Site Qualification and Setup

  • Conduct qualification visits
  • Develop and ship site regulatory binders
  • Generate, collect and review regulatory documents
  • Collect IRB documents
  • Oversee shipment of clinical supplies, drugs, devices
  • Develop screening and enrollment logs

Investigator Meetings

  • Organize and plan investigator meetings
  • Conduct investigator meetings

Site Initiation, Monitoring and Close Out

  • Conduct initiation visits
  • Monitor subject enrollment
  • Develop multimedia advertising templates
  • Conduct routine monitoring visits
  • Perform site audits
  • Prepare project newsletters
  • Oversee return shipment of clinical supplies, drugs, devices

Medical Writing

  • Create expert reports/summaries
  • Generate clinical study reports

Regulatory Submissions and Management

  • Regulatory strategy and lifecycle management
  • Prepare, submit and maintain INDs, NDAs, BLAs, IDEs, PMAs, 510(k)s
  • Manage FDA Meetings: PIND, EOP2, PNDA, Other
  • eCTD Publishing Services
  • Serve as Authorized Regulatory Agent

Data Management and Biostatistics

  • Review clinical protocols for statistical content
  • Calculate sample sizes for clinical studies
  • Generate randomization schedules
  • Develop statistical analysis plans
  • Perform statistical analyses
  • Assist with data interpretation and report writing

Let us lead your dermatology product development program through the complex maze of non-clinical, clinical and regulatory hurdles to an FDA approval.Get started