Bayesian Methods for Joint Longitudinal and Survival Data
Home > Our Services >
Clinical Program Development
Confidence Beyond Compliance
PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs.
Our aim is to help our clients strategically navigate through the various phases of clinical development to ensure the client creates a robust, innovative strategy to maximize asset value and the probability of success.
Our services include:
Our expert clinical development team will partner with our client to create a Target Product Profile (TPP) which will serve as a solid foundation on which to guide clinical development in support of the targeted label indication, and improve communication to regulatory authorities. Our blend of expertise in clinical, regulatory and clinical statistics understand that each of our clients have unique and different clinical development needs. Together this team looks at our clients milestones, end goals and through provision of innovative clinical development knowledge, create a clinical development program designed to gain both regulatory approval and achieve commercial success.
PharmaLex’s clinical development differentiator is our cross-functional and clinically focused team who provide innovative strategic and tactical solutions to optimize and de-risk drug development.
- Insightful and forward strategic design of individual Protocol / Synopsis for clinical trials that incorporate current best practice and are aligned with regulatory guidance and precedence
- Includes the opportunity to answer key questions and gaps and explore additional supportive potential benefits or points of differentiation.
- Innovative clinical trial and program design with strategic endpoint development (including patient-reported outcome measures) supporting differentiated labels, adaptive features in Phase II and III trials, and safety evaluation plans for specific adverse events or interest.
- Insightful and forward strategic design of individual Protocol / Synopsis for clinical trials that incorporate current best practice and are aligned with regulatory guidance and precedence
- Includes the opportunity to answer key questions and gaps and explore additional supportive potential benefits or points of differentiation.
- Innovative clinical trial and program design with strategic endpoint development (including patient-reported outcome measures) supporting differentiated labels, adaptive features in Phase II and III trials, and safety evaluation plans for specific adverse events or interest.
- Statistical input to the study design and protocols for sample sizing, randomization and statistical analysis plans
- Simulation, PK / PD modelling and analysis
- Benefit Risk Analysis
- Pediatric development, rare and orphan disease
- Biomarker and bioassay qualification
- Analyses of complex data and signals
- Provision of clear and concise documents
- Clinical study reports, protocols, CRF Design, investigator’s brochures, manuscripts,
- Toxicological non-clinical and clinical expert statements
- Provide strategic overall management of the project and will be the point of contact between the client and PharmaLex
- Managing the overall clinical development program and monitoring progress and budget
- Identifying and managing risks and issues and taking corrective actions
- Coordinating the projects and vendors required for the clinical program and their interdependencies and managing resources across projects
Related Resources
Related Services
- About Us
- ANDA Withdrawals
- ATMP / Cell and Gene Therapy - Lorem ipsum dolor sit amet, consectetur adipiscing elit
- Authorization / Approval
- Biopharma
- Biopharmaceuticals
- Brexit
- Careers
- Choose A Service
- Clinical Data Management
- Clinical Development
- Clinical Trial Applications
- Clinical Trial Safety Support
- CMC Services
- Commercialization Readiness
- Commissioning, Qualification, and Validation (CQV)
- Computer System Validation (CSV)
- Contact us
- Corporate Social Responsibility
- COVID-19 Authority Updates
- COVID-19 Support
- Custom Software Development
- Customer On-site Support
- Data Protection
- Digital Health Questionnaire
- EU QPPV / National QPPV
- Global End-to-End Outsourcing
- Global Procedure Management
- Global Reach
- GxP Services
- Health Authority / Agency Interaction
- Healthcare Compliance and Medical Approval
- Home
- ICSR (Individual Safety Case Report) Management
- Imprint
- Industry Expertise
- InfoDoc Login Test
- Integrated Product Development
- Interim / Contract QA
- Known Issue
- Lab Tools
- Literature Monitoring & Screening
- MAA / NDA Submissions
- Management Team
- Market Access
- Marketing and Labeling Activities
- MedTech Services
- Mergers and Acquisitions (M&A) Transfers
- News & Events
- Nitrosamines
- Notifications
- Our Milestones
- PAI Readiness
- Pharmacovigilance Consulting
- Pharmacovigilance Quality & Compliance
- Pharmacovigilance Systems
- Post-approval / Maintenance
- Program Management
- Q&A Showcase
- Quality Management Systems
- Regulatory Operations
- Scientific Advice
- Scientific, Regulatory and Technical Writing
- Search
- Signal Management
- SMART MDR
- SMARTAUTOMATE
- SMARTCHECK
- SMARTCHECK MDR
- SMARTCHECK-MDR
- SMARTDECISIONS
- SMARTENOVAL – analytical method validation software
- SMARTPHLEX
- SMARTRISK
- SMARTSEELVA – bioassay validation software
- SMARTSTABELITY – product stability and shelf-life estimation software
- SMARTTRACE
- SMARTTRANSVAL – analytical method transfer software
- SMARTVIGICONTRACT
- SMARTVIGILIT
- SMARTVIGISCREEN
- Statistical Services
- Statistical Services Contact Us
- Statistical Training
- Statistics and Data Science
- Statistics Software Login
- Tech Transfer / Scale-up
- Technology Enabled Services
- Terms and Conditions
- The Discovery to Non-clinical Phase
- Tobacco and Vape Products
- Toxicology Services
- TS XPT Generator
- Virtual Audits
- What Our Clients Say About Us
- Working at PharmaLex
- Your Application Process
What our clients say
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLex
CEO PharmaLex
PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.
Top 10 Pharma Company
President
President