Gowth, Vaccines, People

S-cubed has seen continued growth this year and our consultants continue to deliver great value to our clients.

We have built new relationships and are seeing high demand for our services but as always, it’s our great team of people in the UK and Denmark that are responsible for our wonderful reputation and work ethic. S-cubed is a great place to work, with flexibility, integrity, openness, and fun as our core values, we expect our team to grow again in 2022.

S-cubed ApS – Update from Scott McGregor, MD

We have been extremely fortunate here in Denmark, that society has been so open, and that business has thrived. We returned to the office for most of the year and have only recently returned to working from home. We have continued with our tradition of shared breakfasts on Friday and brought in a Wednesday breakfast to bring the team together after so long apart. We were also proud supporters of Knæk Cancer and had our own ‘Bake Off’, it was a true feast of cake and biscuits.

Knæk Cancer

Our team’s excellent cakes and the winner of our Bake Off, Andreas, our new statistician. 

Company culture is so important when we are living in difficult times. We really are, ‘Our People,’ and we are fortunate to have such determined and hardworking staff. The management team and I, thank them for everything they do.

SAS and Statistical Programming

We have had an incredibly successful year with our programmers fully deployed and seeing increasing demand. This work continues to be at the core of what we do, and we are now building a larger team, you can find out about that here.

Biostatistics

Our statistical consultancy is also growing, and we are proud of the wonderful statisticians who deliver high quality work. One of the reasons people enjoy working for us is the variety of projects that they can work on. Whether it’s with a small start-up biotech or a top 10 pharma, our consultants can explore their interests and build a portfolio of experience.

Data Analytics

What an incredible year our team have had! They are working with large pharmaceutical companies in Denmark and across Europe and leading ground breaking data visualisation projects. Where the team have most impact is in delivering maximum value to clients’ most precious asset: their data. With their open approach and ability to get straight to the heart of a client’s challenges, they really have embodied S-cubed’s values. We’re also looking for more staff to join our experienced Qlik consultants.  

Extend BI

This year has been fantastic on multiple accounts. Firstly, we have doubled our customer base compared to last. At the same time, we have managed to keep almost all existing customers on board which we believe is a testament to our fast and dedicated support. On the product side, we have pushed the benefits of Komment and Kaptain even further, allowing our customers to fully utilize the power of the Qlik Sense analytical platform. We have also seen an increased cooperation with other great Qlik partners around the world which has led to Extend BI’s extensions being used in all parts of the world. We very much look forward to an exciting 2022, where we might even be able to attend Qlik World and meet more Qlik customers.

S-cubed Biometrics UK – Update from Mark Baillet, MD

Services

2021 has been a very busy year for S-cubed Biometrics. Our spread of clients and project types has remained extremely good, with services ranging from statistical consultancy through to data management and study reporting, with many being requested for CDISC standards. Repeat business remains very high, which shows clients are coming back to us time and time again, and are taking advantage of our flexible, dynamic and high quality support.

COVID-19 Support

Although we support all therapeutic areas, our reputation and expertise in virus trials is now well established in the industry and has allowed us to work on a number of Covid-19 clinical trials and projects this year. This includes Covid-19 vaccines, treatments and other Covid-19 virus related activities. From a personal perspective, it’s been incredibly satisfying that we have been able to be part of the Covid-19 effort, and it’s been very rewarding to support so many projects with our expertise. If you are planning any Covid-19 or virus trials next year and are interested in our support then please do let us know.

Data Management

There continues to be a good uptake of our clinical database services, at both traditional clinical sites, but also academic sites, and the cost-effective databasing solutions we provide are at the heart of that.

Statistics

On the statistical side, we have supported a number of clients this year in their study designs, sample sizing, ad-hoc consultancy and statistical reporting, with many studies being reported to CDISC standards.

Finally, I’d like to take this opportunity to wish our exceptional team and all our clients a great Christmas and happy new year.

Regulatory Affairs S-cubed Ltd – Update from Mark Lipscombe, MD

The Regulatory Affairs and Quality Assurance team here at S-cubed Limited has had an incredibly busy year supporting our clients around the world. Looking back over the year’s activity, we continue to provide a full spectrum of support to companies ranging from large pharma to small biotech, and from medical device companies to generics suppliers. Some of our work this year has been directly supporting the efforts against Covid-19, as well as a full range of other therapeutic areas.

We recognise that each of our clients has specific needs and issues, and all of them need an experienced and focused approach to provide the help that they require. We also continue to work with a large network of consultants and subject matter experts, to bring specific expertise to our projects when needed.

As a snapshot of activities being performed, we are currently working with our clients to provide the following services:

Regulatory Affairs

  • Preparation and submission of Clinical Trial Applications to numerous countries, and corresponding notification of substantial amendments
  • In house regulatory support for a variety of clients and locations
  • Support for preparation and submission of Marketing Authorisation Applications for several clients
  • Support for Orphan Medicinal Product Designation applications and Paediatric Investigation Plans (PIPs)
  • Collation/preparation of CMC documentation
  • Interactions with EU regulatory agencies, requests for and management of scientific advice meetings
  • IMPD/Protocol/Investigator Brochure input, collation and writing
  • Promotional/non promotional materials review
  • Information searches

Quality Assurance

  • We have arranged a variety of GCP/GMP/PK/PV audits for our clients this year
  • We have supported clients with the design, implementation and management of their Quality Management Systems, including SOP writing
  • Wholesale Dealer Application QA system support and provision of a Responsible person

We also continue to provide support as a European representative for SME clients, act as a Data Protection Officer and as an EU legal representative, via our subsidiary in Copenhagen. On top of this our team have regularly attended courses and conferences, to keep up to date with the latest industry and regulatory news.

I would again like to take this opportunity to thank the fantastic team here at S-cubed for their hard work and commitment this year, and I wish the team and all our clients a very happy Christmas.



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