S-cubed Biometrics Mark BailletWhat is it that makes S-cubed’s Biometrics a trusted partner? Mark Baillet, discusses what you should consider when looking for a partner.

S-cubed Biometrics supporting your activities on a clinical trial

Besides the large variety of project-based Biometrics services we provide, we are often called in as Senior Statisticians and/or Senior Data Managers, to support clients who have already contracted out the full set of trial services to a full-service CRO. More often than not, they have no in-house Statistician or Data Manager employed to review and approve Biometrics related activities which they are performing. Knowing who to choose to support you is an important decision but, we are an experienced team. Furthermore, we are always happy to provide that real value-add advice, and guide you on all aspects of Biometrics in your trials.

Key factors to Consider

One of the key factors that you have to consider is trust and that is created through an open and honest collaboration. Our team are experienced and knowledgeable and, as such, deliver exceptional results every time. We can see the challenges that our clients are facing and can identify where they will need that extra support. This is where we excel whilst being honest, collaborative and determined. This open and constructive dialogue is why clients come back to us again and again.

Statistical Support

Where we offer statistical support, we in effect sit as the “company statistician” acting on your company’s behalf (although ultimate responsibility still remains with you), to carry out activities such as:

  • Statistical review of protocols
  • General advice on study design and sample sizing
  • Statistical analysis plans (SAPs) review
  • Blinded dry-run Tables, Figures and Listings (TFLs) review
  • Commenting on final unblinded outputs
  • Review of clinical study reports (CSRs).

From my perspective, our detailed focused team always deliver a highly personalised service to our clients. Our range of experience across many years in the industry means we have developed consistent and reliable approaches for statistical support.

Data Management Support

Our data management team are well known for their high-quality work. Over the years, we have presented at PHUSE, CDISC and other professional forums which keeps us informed and up to date with the latest information. It’s been at the core of our work with clients for the last 10 years and continues to be so. Most importantly, I believe our team inspires confidence. How? By being accurate and consistent. Our mantra of, ‘First Time, Every Time’ is key to understanding our mindset and at the critical phase in the drug development process.

We offer a wide range of services and support such as:

  • Data Management Plan (DMP) review
  • Data Validation Plan (DVP) review
  • eCRF review
  • Review of data validation checks
  • Database user acceptance testing

For both the Statistician and Data Manager roles we can work on behalf of the client to help manage the CRO (liaising directly with their project manager) to assess timelines, discuss and resolve ongoing issues, and tracking data flow, data entry, data queries, etc. In addition, we can routinely attend data review meetings, and also regular project team meetings.

Additionally, if the full-service CRO is contracted to produce datasets in CDISC format (along with other CDISC deliverables, e.g. Define.xml, SDTM annotated CRF, reviewer’s guide) then we can provide a service whereby our S-cubed experienced CDISC programmers can review the CRO’s CDISC deliverables for compliance against the latest FDA standards.

Why choose us?

I suspect many companies could claim that they are fast, accurate and efficient. At S-cubed Biometrics we’re more than that, we are your trusted partner and we become part of your team. Our clients return to us year on year because they know we deliver what they need. So if you are looking for a new partner, or would like to talk to us and get some advice, then get in touch, we’d be happy to help.

Contact our Biometrics Team, if you require any further guidance or support.