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Flexible Approach

Clinical Trial Design

Quality Statistical Consultancy

Whatever the stage of clinical development, we recognise that statistical input is critical to the success of any study. We can support you in:

Study Design and Protocol Development

Engaging with a statistician at the early stages of the protocol development process will ensure that your study is appropriately designed to answer the objectives and substantiate product claims. We can assist with sections including randomisation and blinding, definition of endpoints, sample size and statistical methods.

Sample Size Calculations

One of the pivotal aspects of planning a clinical trial is the calculation of the sample size.

Starting with a clear definition of the primary endpoint and the treatment effect of interest, PCS then utilise historical data and relevant publications to derive an informed sample size estimate for your study.

Generating Randomisation Schedules

Randomisation and blinding are fundamental in most clinical studies. PCS is able to generate and store the randomisation schedule for your study. If we are also analysing your data, an independent statistician will be assigned to this task to ensure blinding is maintained.

Statistical Consultancy Services

Pharmaceutical and Healthcare
Protocol Development

Expert statistical input into the protocol to ensure your study is appropriately designed to answer the objectives.

SAS Programming

Development of a suite of SAS programs to generate report ready tables, figures and data listings.

Sample Size Advice

Utilisation of historical data and relevant publications to provide sample size estimates.

Statistical Analysis

Preparation of a statistical analysis plan, and usage of the most appropriate statistical methods to leverage your study data.

Randomisation

Preparation of randomisation schedules.

Clinical Reports & Publications

Statistical input into the clinical study report and analyses for publications.

Darren worked for us at a top five global pharmaceutical client where he worked as a Sr. Technical Team Leader. He had exceptional team working skills and worked very well within a multifunctional team of Statisticians, SAS programmers, Data Managers, Study Managers and Clinicians. He was a wonderful contributor to the success of our services to the client and I fully recommend his service.
Bonnie Knowles Johnson, Senior Business Development Manager, Clinical Staffing, Inventiv Health Clinical.
We engaged Darren as an interim manager of our statistics department and were delighted by his level of engagement and his deep expertise in clinical trial statistics. Darren has specific experience in OTC medicines that proved invaluable to study design and analysis plans. Darren is able to communicate complex statistical concepts in lay terms, which facilitates great team discussions. Darren is familiar with all the relevant regulatory guidance as it pertains to clinical statistics. We would recommend him as a consultant or interim manager.
Louise Rowe, Head of Clinical Research, leading Fast Moving Consumer Goods (FMCG) company
Primoris CS has been supporting our teams with data management and statistical analysis activities since 2017. The work delivered has been of consistent quality and within agreed timelines. Darren is a knowledgeable, diligent and reliable professional who has built an efficient working relationship with our departments. The feedback from our team on Primoris CS services is excellent.
Emilie Rodenburger, Director Clinical Affairs, Clinuvel (UK) Ltd