OUR HEALTHCARE SOLUTIONS

Biostatistics

Since the very beginning of CRA research company, one of the key services has been biostatistics. Our team has great experience in all research and development phases, from clinical to post-marketing analyses. We have made flexible and efficient procedures which enable our services to follow deadlines, terms and budgets with the rigorous control of quality in every step of the way. We want our clients (pharmaceutical and CRO companies, clinics and others) to recognise us as a long-term and reliable partner so that we could freely set on a long distance journey of clinical studies.

The protocol of clinical study deals with goals, design, methodology, statistical procedures and the organisation of clinical study. Protocol defines study duration, the criteria of inclusion or exclusion, administration, tasks and the responsibilities of all participants. Our clients can rely on us in the fields of protocol related to statistics and the methodology of research. Our clients can expect our assistance in parts of the protocols related to statistics and methodology of research.

Sample size and power analysis

Optimal sample size calculation in clinical studies insures the calculation of reliable data without unnecessary costs and time loss during interviews. This process needs to be compatible with precise methodology, budget and with the client’s decisions. Why? The calculation of sample size sometimes increases originally planned number of interviewed subjects, requires the reduction of the variability of observed measure or creates new stratification (to decrease the size of a study). Taking into consideration these facts, we deal with this process in team work, with our clients.

Statistical Analysis Plan (SAP)

The plan of statistical analysis contains detailed description of all statistical analyses which would be applied on collected data during clinical study. It has comprehensive tables’ description and graphs which would be presented in final report.

SAP defines:

Primal and secondary study goals
Coding procedures and data transformation
Sample size and randomisation
Demographic and basic sample characteristics
Efficiency and safety method

Questionnaire Design (CRF)

Questionnaire Design is an important phase generally, especially in clinical studies. The significant determinants of electronic and non-electronic forms of CRF are the structure and content of letter, form and the measure of variables’ level. Clinical Report Form is designed after the completed protocol of clinical study and it has to include all determinants defined by protocol. Well-designed CRF is crucial in providing data required by protocol and for the adjustments with legal regulations. It affects needed time, enables the control of entered data and allows accessibility of all (most) required data.

Protocol of Clinical Study

Mostly used documents are paper CRF formats. Data need to be carefully entered in an electronic data base. CRA research has no tolerance to differences between paper CRF format and electronic data base. This process is strictly controlled because it is crucial in securing the reliability of the analysis and the conclusions drawn from it.

Data entry

Statistical analysis is specific for clinical studies in many ways. It is focused on goals defined by the protocol of clinical studies.

CRA’s statisticians use various statistical methods:

Descriptive Statistics

Central Tendency Measures (mean, median, etc.)
Variability measures (variance, standard error, confidence interval, etc.)

Categorical variables analysis

Chi – square test
Binomial test

Mean difference analysis

ANOVA
Repeated measures ANOVA
T – test

Correlation analysis

Regression analysis

Simple and multiple linear regression analysis
Nonlinear regression analysis
Simple and multiple logistic regression analysis

Other multivariate statistical techniques

Cluster analysis
Discriminant analysis
Canonical correlation analysis
Factor analysis
MANOVA
ANCOVA
SPANOVA

Internal consistency analysis

Survival analysis

Log–likelihood analysis

Specificity and sensitivity tests

Nonparametric replacements for mentioned parametric tests

Statistical analysis and modelling

Clinical Study Report (CSR) is a detailed document that contains all information related to the study. Clinical studies last long and cost a lot. It is necessary for final report to be precise and detailed and to include all relevant data (results testing, information about safety and medical efficiency, detailed information about methodology, study duration, study inclusion criteria, disease information, medicine application, comorbidities, etc.).

In cooperation with our consultants (DMedSc) we provide our clients the full service of CSR writing with the MedDRA classification of medical terminology.

Clinical Studies Reports (CSR)

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