Clinical Development

tranScrip provides multi-functional, highly capable clinical development and clinical study teams to complement your own resources - precisely when you need us.

tranScrip provides multi-functional, highly capable clinical development and clinical study teams to complement your own resources – precisely when you need us.

Our team of experts support activities that are usually conducted by pharma companies in-house. We stay close to our clients throughout all phases of product development, providing flexible, expert resources rapidly to meet changing needs. We deploy our team of clinical development and operations experts, alongside highly skilled clinicians, statisticians and research scientists, all with an enormous amount of industry experience and a track record of delivering.

Partnering with us, you’ll benefit from your own bespoke team, further supported by our extensive company-wide scientific and medical knowledge. Our specialists are right there with you, complementing your existing resources and supplying a flexible, highly skilled resource to meet your evolving needs.

“...tranScrip delivered high-quality data in a consistently changing environment where each wave of the COVID pandemic brought new challenges to overcome. tranScrip’s approach of working closely and flexibly with Sponsor and CROs ensured the project met its goals. ”

CEO, Biotech

Our expertise is your expertise

Whatever it takes to bring your drug product or device to market, we’re ready to step in and provide expert assistance and advice. Whatever your goal, we help make it happen.

Target Product Profiles (TPP) & Clinical Development Plans (CDP)

A successful clinical development programme is underpinned by optimal TPP and CDP that are clinically and commercially viable. We help our clients develop and adapt their TPP and CDP from early development through to life-cycle management.

Our clinical development and operational experts, support smart design of First-in-Human, proof of concept and registrational studies, including considerations of adaptive design and biomarker strategies.

Regulatory

tranScrip provides a complete regulatory engagement service including regulatory strategy, IND/IMPD development, scientific advice, clinical study approvals and NDA/MAA preparation.

Find out more about our regulatory affairs consulting serivces

Medical

Our highly experienced medical team supports our clients with clinical strategy and clinical development plans, protocol design, medical monitoring/oversight of studies and can assume the role of Chief Medical Officer if required.

We excel in interpretation of data throughout the development programme and provide smart recommendations to our clients to increase their chance of success. Our team of experts include several ex-regulatory agency medics, providing additional insight into how to present data to regulators.

Drug Safety

Our specialist medical and operational drug safety team can support planning, set-up and management/oversight of PV activities, including provision of an EU required Responsible Person, the safety management plan, SAE management and periodic safety reporting.

Find out more about our drug safety services

Clinical Study Delivery

tranScrip’s clinical operations specialists support delivery of clinical trials directly or via oversight of CROs.

We provide our clients with an outsourcing strategy, CRO/vendor selection, and sponsor required oversight of those vendors.

We provide study management team leadership with a process that focusses on risk management to enable high quality data delivered in compliance with ICH-GCP.

Find out more about clinical study delivery

Medical Writing

A well written document can ease the review path for regulators and development partners, reducing risk and maximising opportunities.

Our highly experienced medical writing team delivers a comprehensive suite of high-quality documents from regulatory briefing documents, paediatric plans, protocols, study reports to NDAs and MAAs.

Find out more about medical writing

Quality

Our quality experts support start-ups with a “fit-for-purpose” Quality Management System (QMS) and management of the QMS.

We can arrange and oversee quality audits such as vendor qualification audits, clinical study site audits, company internal audits and can support inspection ready activities for our clients.

Capability Overview

09 May 23

Contact our team of experts

Our physicians, scientists and service experts can help to maximise the value of your products. Whatever your project requires, we have the people to meet your needs.