Biostatistics Services

GK ANALYTICS has been built around the expert knowledge and reputation across the industry of our statistical consultancy team. Our team has experience in all phases of research and development from pre-clinical analysis to clinical and post-marketing support across a wide range of therapeutic areas. GK ANALYTICS also provides all levels of support from bespoke consultancy for protocol design through to study level analysis of Tables, Listings and Figures.

Our biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible. We pride ourselves on our expertise and the ability to show clear results to our customers. We also take a personalized approach dependent on our client's needs which forms lasting partnerships and enables our experts to transfer their biostatistics knowledge on to our customers.

GK ANALYTICS is renowned for our employee's depth of experience in biostatistics. Typically, our statistical consultancy services focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization. We also print randomization envelopes using custom-made NCR envelopes for maximum security.

Our Clinical Biostatistics Services include:-

Pre-Clinical Studies

we provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.

Protocol Input

our input includes clinical study design, sample size calculations and consultancy advice during the startup of a study.

Randomization/Unblinding

we offer production of randomizations including production of emergency unblinding envelopes.

Statistical Analysis Plan (SAP) and Output Shells

we optimize the use of our Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.

Clinical Data Interchange Standards Consortium (CDISC)

using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.

Output Production

using GK ANALYTICS standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.

PK/PD Analysis

PK/PDanalysis will be performed using in-house standard macros within the SAS ® Programming.

Production of Statistical Report/Clinical Study Report

our statistical and medical writing teams collaborate to produce high quality reports.

Interim Analysis/Data Safety Monitoring Boards (DSMBs)

we offer unblinded statistical support and advice for Interim Analyses and DSMBs.

Meta Analysis

our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.