Early development can be a challenging undertaking, whether you're familiar with the process or not. At tranScrip, we deliver bespoke early development support, covering everything from product strategies and target product profiles to preclinical and clinical development strategies and associated plans.
We design and implement IND-enabling programmes, first-in-human studies and proof-of-concept clinical trials. Consideration of commercial viability and the Target Product Profile (TPP) of a potential product is central to our thinking. Our skill set covers areas such as commercial strategy, preclinical, medical, statistical, clinical operations, regulatory, and drug safety services.
Our team of experts supports activities that are usually conducted by pharma companies in-house. We’re ready to provide multi-functional, highly capable teams to complement your own resources – precisely when you need us.
Partnering with us, you’ll benefit from unrivalled access to a breadth of scientific expertise, strategic insight and delivery support. Our specialists are right there with you, complementing your existing resources and supplying a flexible, highly skilled resource to meet your evolving needs.
Senior VP, Clinical Development, Biotech
We can perform gap assessment for your early development asset, develop a target product profile (TPP), prepare a preclinical plan to support an IND-enabling package, advise on the best strategies for engagement with Competent Authorities and carry out the necessary regulatory interactions.
We can help you prepare the investigational new drug application (IND) and clinical trial application (CTA) packages, including toxicology, safety pharmacology, CMC, pharmacokinetic/pharmacodynamic (PK/PD) and phase 1 study designs/protocols.
Our early development team can support the strategy for phase 1 and 2 studies, including study design and protocol preparation across a range of therapy areas. We can also provide multi-functional teams to support study delivery, from developing a “fit-for-purpose” Quality Management System (QMS), to vendor selection and oversight, regulatory activities, medical monitoring and pharmacovigilance.
We provide you with the extra personnel and expertise complementing your own resources.
You’ll have access to a wealth of scientific acumen, available as and when required to advise and support early development activities. We ease the burden of having to manage multiple vendors, thanks to our broad range of support – including development strategies, study delivery, therapy area-specific knowledge, and our significant collective experience in drug development.
We have teams of life science and R&D experts to help achieve your goals and seize opportunities. Whatever your project requires, we have the people to meet your needs.