As we rapidly reach the end of 2019, it’s a great time to reflect on a successful year.
Staffing and New Office
S-cubed has grown again this year, adding 9 new members of staff to our teams in the UK and Denmark. In Denmark, the team have moved to beautiful new premises at Nordhavn. S-cubed continues to be a fantastic place to work, giving all staff the opportunity to develop their career and have a good work/life balance.
S-cubed ApS – Update from Scott McGregor, MD
SAS and CDISC
It’s been a busy and exciting year for us at ApS. We have grown and expanded the work we are doing in all areas. SAS Programming and CDISC remain at our core and clients continue to seek us out for expert advice and support. With members of our team as CDISC authorised trainers for SDTM and ADaM and represented on the European CDISC Coordinating Committee, we continue to experience high demand for implementation advice. Our team of statisticians have been working with an increasing number of clients across Denmark and we have been delighted that their work continues to expand through recommendations.
A3 and Qlik
It’s been a fantastic year for the A3 team too, with the Community MDR launched and now with over 60 users, from 24 countries, represented by 15 companies in just 3 short months. It’s incredibly satisfying to see people gaining use of the system. To add to this success we now have sponsor companies using the commercial MDR to manage their own and CDISC terminology.
Our Qlik team became Qlik Elite Partners in November 2019, recognising their hard work and innovative use of Qlik Sense. They have entered into new relationships with other Qlik partners who are reselling their Qlik extensions. The Komment™ extension continues to be the biggest seller and you can easily register for a demo via the website. However, it is not just the extensions that have caught the imagination, the Lean Trial Monitoring platform launch by the team this year, gives in depth analytics for medical monitoring and you can read more about their work here.
Finally, with additional developers, increased numbers in our Qlik team, and new consultants, we had outgrown our offices at Nyhavn. It took us considerable time to find suitable premises with space to grow, the ability to host meetings and training, and meet the requirements of our quality brand. We also wanted to be in a sustainable building and where transport links were good and everyone, whether travelling by bike, on foot, via public transport, or by car could easily get in and out of the office. For our staff who regularly travel from Sweden by train, or visitors coming from Copenhagen airport, we knew that taking into consideration the metro expansion would also be an important factor.
With all these considerations, finding our beautiful new surroundings at Nordhavn (harbours seem to be a theme in our company) is fantastic. The view is great out over Svanemøllen Havn and we’re looking forward to welcoming clients and friends to the offices in the new year.
I want to thank all our staff who work so hard to maintain our quality focused brand, whether they are on site or based in our offices. I wish our team, our clients and friends a happy Christmas and a prosperous new year.
S-cubed Biometrics UK – Update from Mark Baillet, MD
2019 has been another strong year for S-cubed Biometrics. Our spread of clients and project types is extremely good, with services ranging from building study databases through to data management and study reporting, with many being requested to CDISC standards. Repeat business remains very high, which shows clients are coming back to us time and time again, and we’ve continued to recruit new staff this year as a consequence.
We are seeing a real demand for data management and statistical oversight support now, including helping our clients assess their CDISC datasets for CDISC compliance once they have received them from third parties. Our clients appreciate the oversight support we provide, especially when linked to the ICH GCP E6 (R2) Addendum sponsor oversight requirements.
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.
On the statistical side, the addendum to ICH E9 (Statistical principles for clinical trials) on estimands and sensitivity analysis in clinical trials is now published and is set to change the way clients write their protocols. S-cubed are at the forefront of this, and you can read our article from Darren Jolliffe here. We will be working with our clients in 2020 and beyond to advise and help them through these changes. If you’d like to know more then please let us know.
I’d like to take this opportunity to wish our exceptional team and all our clients a great Christmas and happy new year.
S-cubed Limited – Update from Mark Lipscombe, MD
The Regulatory Affairs and Quality Assurance team here at S-cubed Limited has had another very busy year performing great work and providing fantastic support to our clients in the UK, US and Europe. Reviewing our activities over the recent months, we can see that we provide a full spectrum of support to companies ranging from large pharma to small biotech, and from medical technology to generics suppliers. Each client has specific needs and issues, and all of them need an experienced and focused approach in order 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:
- 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
- We have arranged a variety 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 like to take this opportunity to thank the team here at S-cubed for their hard work and professionalism again this year, and wish the team and all of our clients a very happy Christmas.
Get in Touch
If you have any questions or comments, we’d love to hear from you, you can contact us through the website, via email or call our offices.