Clinical Development Services
PharmaLex provides global Clinical Development Services 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.
Contact our specialists to tailor a service plan
Our services include:
Clinical Development and Clinical Strategy Consulting
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.
Synopsis and protocol 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 Phase III trials, and safety evaluation plans for specific adverse events or interest.
Clinical Statistical Team provide the following services
- 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
Clinical Development Medical Writing Services
- Provision of clear and concise documents
- Clinical study reports, protocols, CRF Design, investigator’s brochures, manuscripts,
- Toxicological non-clinical and clinical expert statements
Clinical Program Manager Services
- 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
Trial Master FIle (TMF) Services
Take Control of Your TMF With Our Expert Services. Stay in the TMF Healthzone with expert, scalable services from the global TMF authority. Learn more
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Smart & Streamlined
Given our expert understanding of the clinical research, regulatory and competitive landscape, PharmaLex is perfectly positioned to offer smart strategies and tactics for drug development across the entire therapeutic spectrum.
Our expert statistical analysis team offers support with the design of streamlined yet powerful statistical analysis plans.
Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development needs.
In keeping with our aim to deliver innovative solutions, we use proprietary software that streamlines wherever possible—including automating redaction, transferring analytical methods between labs or validating bioassays and physico-chemical methods.
Big Data & Beyond
From data science to clinical trial applications, orphan drug designation to statistical services, scientific writing to IMP management, our broad range of services covers every eventuality.
We’re ready to help you:
- Analyze clinical trial data accurately to guide future trial and development decisions
- Optimize study design and clinical protocol with biostatistics
- Improve clinical development programs with randomization, statistical analysis and study powering
- Define TPP to support the target label
- Manage global development programs for tissue, cell and gene therapy products, biosimilars and new biologics, pharmaceutical and orphan drugs
- Implement early phase modeling to schedule development activities at their most effective point
- Support business development with portfolio reviews and asset repositioning
Clinical Trial Applications
PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.More Info
Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development strategies needed.More Info
Toxicological Services and Risk Assessment
Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market.More Info
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PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.