At tranScrip, we specialise in navigating the complexities of early clinical development, offering comprehensive services from product strategy formulation, defining target product profiles to the delivery of proof-of-concept studies. Our team of experts are dedicated to ensuring the successful transition from preclinical to clinical phases, helping you bring innovative therapies to patients efficiently and effectively.
We design and implement IND-enabling programmes, first-in-human studies, and proof-of-concept clinical trials with a relentless focus on commercial viability and the Target Product Profile (TPP) of potential products. Our comprehensive expertise spans commercial strategy, preclinical research, medical, statistical analysis, clinical operations, regulatory compliance and drug safety services across all therapeutic areas.
Maximise the value of your products with our bespoke solutions.
Developing a strong product strategy is crucial for the success of any new therapy. We assist in crafting detailed Target Product Profiles (TPPs) that outline the intended use, safety, efficacy, and quality attributes of your product, aligning them with market needs and regulatory requirements.
Key Services:
• Market analysis and competitive landscape assessment
• Definition of product attributes and differentiation
• Regulatory and commercial alignment
Our team guides you through the Investigational New Drug (IND) and Clinical Trial Application (CTA) processes, ensuring all necessary preclinical studies are conducted to support your applications.
Key Services:
• Preclinical study design and management
• Regulatory documentation and submission support
• Toxicology, pharmacology, CMC, pharmacokinetic/pharmacodynamic (PK/PD) studies and phase 1 study designs/protocols
We provide end-to-end support for clinical pharmacology and PoC studies, crucial for determining the viability of your therapeutic candidates. Our approach ensures robust data collection and analysis, informing critical decision-making.
Key Services:
• Study design and protocol development
• Site selection and clinical trial management
• Data analysis and interpretation
Understanding the relationship between drug exposure and response is essential. Our PK/PD experts employ advanced modelling and simulation techniques to optimise dosing strategies and predict therapeutic outcomes.
Key Services:
• PK/PD study design and execution
• Data modelling and simulation
• Dose optimisation and exposure-response analysis
Our formulation development strategies ensure that your product is not only effective but also manufacturable and stable. We work with you to develop formulations that maximise patient compliance and therapeutic efficacy.
Key Services:
• Formulation screening and development
• Stability studies and scale-up support
• Manufacturing and CMC (Chemistry, Manufacturing, and Controls) guidance
Our teams of experts are equipped to support functions typically managed in-house by pharmaceutical companies. We provide multi-functional, high-calibre teams to seamlessly integrate with your resources, delivering bespoke services tailored precisely to your needs, exactly when you need them.
Partnering with us gives you unparalleled access to an extensive pool of strategic expertise, therapeutic experience and operation excellence. Our specialists work alongside you, enhancing your capabilities and providing a flexible, highly skilled resource that adapts to your evolving requirements.
Chief Medical Officer
Destiny Pharma
Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.
