We help companies bring pharmaceutical products to market
We are proud to be working with more than 25 leading pharmaceutical and biotech companies
Solutions, Knowledge and Expertise
We offer flexible solutions, consultancy, in-house support and full-service CRO capabilities
Our highly-qualified staff are specialists within Biometrics, Regulatory Affairs, and Quality Assurance. Our consultancy work and our products are implemented in some of the most successful health-care and pharmaceutical companies in Europe, the US and Asia
Our services
Biometrics
We have extensive knowledge and experience across the full range of biometrics, data management, analysis and reporting activities. We offer a wide range of services for individual clinical studies through to integrated databases and regulatory submissions support.
\CDISC
As authorized trainers in CDISC SDTM and ADaM, we provide training, hands-on support, and expertise about requirements, processes, and systems to support CDISC requirements. Our CDISC specialists are experienced in implementing standards for small, medium, and large pharmaceutical companies.
Regulatory Affairs
Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds and therapies for orphan indications.
Data Analytics
Visualise and explore your data using QlikView and Qlik Sense. We specialise in implementing Qlik tools for the Pharmaceutical industry. You will be able to optimise the speed and efficiency of your data analysis strategies, improving reaction time and reducing costs.
cQuality Assurance
Whether you are looking to develop quality systems from scratch, wish to update the compliance of your existing systems, or need to verify the quality of work being conducted, S-cubed’s Quality Assurance team has the expertise and experience to assist you.
}Project Management
We provide only experienced Project Managers who have the knowledge, competences and expertise necessary to mitigate risks and create practical solutions. Our Project Managers are experienced in both small, large and multiple projects, and always do their best to integrate seamlessly with your existing team.
Our Products
A3 Suite
The A3 Suite is our innovative and industry leading technological solution for managing CDISC standards and breaking down data silos.
A3 MDR
The A3 MDR manages sponsor and CDISC terminologies, supports the creation and maintenance of Biomedical Concepts and more.
A3 Study Workbench
The A3 Study Workbench uses the MDR for study setup, to generate CRFs, and create Define.xml. It exports a variety of formats and to an EDC.
Qomment
Our write-back extension for Qlik Sense ensures that you can update your data directly from your dashboard. We take you beyond a read only tool, to one where you can create, edit and delete data.
Qompass
This is our intuitive navigation extension for Qlik Sense. A fully customizable navigation menu, makes it easy to navigate between sheets in Qlik Sense applications
Latest news
Global Harmonisation of Clinical Trials
Global Harmonisation of Clinical Trials is the latest focus for our quarterly roundup of the regulatory landscape with news from EMA, FDA and ICH
Protocol writing is changing – Estimands (ICH E9(R1))
This month Darren Jolliffe, explains how S-cubed can assist you in applying the forthcoming regulatory guidance ICH E9(R1)
CDISC 360 Project and the A3 Suite
The CDISC 360 Project is a major change in the way we access and use standards. Our A3 Suite is ready and tuned to the vision.
CDISC, PhUSE, DADM – Events Update
It’s been a busy few months for S-cubed. Find out where we’ve been and where we’re going to next.
Articles
Qlik: S-cubed Commenting Extension
Bohua Li introduces an S-cubed extension for adding user comments in a Qlik Sense application, along with a guide for users to implement the extension themselves.
Regulatory Affairs: An overview of PRIME, Breakthrough Therapy & Fast Track procedures
This article provides an overview of PRIME, Breakthrough Therapy and Fast Track regulatory procedures intended to optimise the development of medicines that target an unmet medical need.
Optimising the path to commercialisation; Who can help and when?
Regulatory Affairs Expert Tony Mitchell co-authors a case study for a new IBS Drug This is case study for a joint project S-cubed worked on for a new drug for IBS – PharmaVentures was the lead company and they were providing market valuation expertise, Apex Healthcare...
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