RRD MODEL AND SERVICES

Clinical Development

RRD Partners benefit from having a fully engaged, seasoned team on day 1, with expertise across all stages of development, from early phase clinical pharmacology through Phase 3, and integrated cross-functional strategic consultation each step of the way.

Value

Accelerate development

Minimize infrastructure development

Rapid start with experienced team

Reduce program risk

Build asset value

Development Strategy and Design

Strategy:
  • Gap analysis for all stages of development
  • Strategic and operational development planning
  • Indication analysis and selection
  • Product labeling
  • Advisory committee support
  • KOL identification and engagement
Study Design and Analysis:
  • Protocol development – synopsis through final protocol
  • Therapeutic expert input – protocol design, population definition, inclusion/exclusion criteria, standard of care, treatment guidelines, medical need, definition of human Proof of Concept (hPOC)
  • Biostatistical support – sample size determination, statistical analysis plan, and interim/final data analysis
  • Regulatory input – evaluation of pathway for previously approved products, study designs utilized, endpoint guidance, FDA/ICH compliance, risk evaluation
  • Data Management – CRF design, data collection systems, and data reporting requirements
  • CMC input – Dosage form, packaging, drug supply and distribution

Clinical Operations

Vendor Identification and Selection

  • CROs, laboratory services, clinical supply management
  • Request for proposal (RFP) preparation
  • Proposal review and negotiation

Clinical Trial Start-Up

  • Site identification and qualification
  • Vendor start-up
  • Protocol and Informed Consent review
  • Development and review of site tools (manuals, aides, logs etc.)
  • Central IRB management
  • Review and approval of site activation documents
  • Clinical study reports

Clinical Trial Oversight

  • Vendor management (CRO, labs, IP supply)
  • Development of enrollment strategies
  • Risk mitigation
  • Management and oversight of GCP compliant eTMFs

Data Management