Clinical Development Services
Uniphar 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
Strategy Development 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
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 Services
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
Clinical Data Management Services
Uniphar provides comprehensive clinical data management services spanning study start-up through database lock and submission. Our team collaborates cross-functionally to deliver high-quality, regulatory-compliant datasets that support efficient analysis and submission.
Study Start-Up
- Data Management Plan
- CRF Completion Guidelines
- Data Validation Plan
- Data Transfer Agreements
- Coding Conventions
- SAP / mock shells review
Database Design
- eCRF design
- Database build
- Database validation / User Acceptance Testing
- User training and access support
Data Cleaning Activities
- Data review
- Query generation / resolution
- External vendor reconciliation
- Medical coding
- SAE Reconciliation
- Metrics reporting
Study Close-Out
- Perform Database Lock and deliver final clean data to Biostatistics
- Â Review:
- Final TLFs
- SDTM annotated CRF
- Draft SDTM datasets
- Pinnacle 21 Reports
- Final Data Package – ensure FDA & CDISC compliance
Need support with study design or clinical strategy and execution?
Schedule a free 30‑minute consultation with Uniphar to align on study design, clinical operations, data management, and next milestones.
