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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
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What our clients say
Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.
Leading European Specialist Pharma Company
Head of Medical Writing and Publications
Head of Medical Writing and Publications
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Lorraine Henry
Compliance Lead, Qualified Person, Amneal Ireland Limited
Compliance Lead, Qualified Person, Amneal Ireland Limited