CROSS METRICS SA

CROSS Metrics is a specialist CRO that provides in house, Clinical Data Management and the full range of Medical Statistics, Biometric and Pharmacokinetic analysis.

The acquired expertise of its team allows to undertake statistical consultancy to manage projects across different study types and across a wide range of therapeutic areas.

Designing clinical trial is vital to ensure that the study leads to unbiased conclusions ending up with valid results and is compliant with ethical guidelines.

CROSS Metrics is an active member of the CDISC consortium (at present with a Gold Membership status), and can provide professional up to date advice on a wide range of aspects concerning clinical trial designs and data management.
CROSS Metrics performs data handling using a fully validated, FDA 21 CFR Part 11 compliant, proprietary, ORACLE based clinical data management system, DM Services include:

  • CRF Design and Production
  • Database Design and Validation
  • Data Entry Screens
  • CRF Log and Tracking
  • CRF Review
  • Dual Data Entry and Verification
  • Programming and Validation of e-Validation Checks
  • Query Generation and Resolution
  • Query Processing
  • Electronic Audit Trail Generation
  • AEs and Concomitant Medication Coding
  • Data Quality Reviews
  • Database Soft and Hard Locks
  • Database Status Updates
  • Archival

The accuracy of the data entry performed during the DM process is verified by an independent secondary entry and a subsequent comparison of the datasets generated to highlight discrepancies. The data are then validated electronically using validation check programs, and queries are produced and solved. At the end of the process the database is audited against the CRFs.

Statistics


After a Quality Control (QC) review the database is exported to SAS in order that the data listing, statistical summary and analysis programming can take place to produce the Tables, Listings and Graphs (TLGs) for inclusion in the Statistical Report (SR). TLGs undergo QC and validation by independent programming of the same summary statistics and analyses. Discrepancies are then resolved.

CROSS Metrics offers Statistical services which includes:
  • Analyses of parallel group trials
  • Analyses specific to crossover designs
  • Longitudinal data analysis
  • Survival data
  • Comparative studies
  • Equivalence/non-inferiority hypotheses
  • Parametric and non-parametric analyses
  • Hierarchical modelling
  • Meta-analyses
  • Repeated measures analyses
  • Multiple regression
  • Analysis of Variance and Covariance
  • Survival/failure analysis (including Cox regression)
  • Generalised linear models
  • Logistic Regression
  • Multiple comparison techniques
  • Biostatistical modelling
  • Monte Carlo methods
  • Simulation

Quality Assurance(QA) for the statistical summary and analysis process ensures that SAS programs are validated for the production of all TLGs by checking that all the study requirements were addressed. QA also confirms that the statistical analysis plan (SAP) was written following SOPs and that all SAPs have the appropriate approvals.

Consulting Services


Besides the full range of DM and Statistical Services, CROSS Metrics provides a huge range of consulting services, which includes:

  • Protocol development and review
  • Sample size calculations
  • Randomisation and code break envelope generation
  • CRF advice, design and review
  • Working alongside EDC systems
  • SAP preparation, include table blanks
  • Executive and full statistical reports
  • Integrated summary of efficacy and safety
  • Post-hoc and exploratory analysis
  • Representative for client at Regulatory Agencies meetings
  • Pooling of studies (meta analyses)
  • Safety and efficacy summaries for regulatory submissions
  • Performing interim analyses and defining stopping rules
  • Providing independent statistician

PK analysis


CROSS Metrics specializes in conducting pharmacokinetic data analysis for preclinical and clinical studies. We perform either model dependent (Compartmental) or model independent (Non-Compartmental) analyses using a validated WinNonlin system.

Non-compartmental Analysis (NCA) of Phase I studies provides the PK results needed for a large array of assessments, including in vitro - in vivo correlations (IVIVC), Average Bioequivalence (ABE), Reference-Scaled Average Bioequivalence (RSABE), food effect, drug-drug interaction, special population PK, drug exposure and drug recovery data. Assessments of PK/PD relationships can be also provided.

Pharmacokinetic Simulations

Basing on the existing PK data, simulation analyses to predict the plasma concentration profile of a drug under different conditions are performed. This information allows previewing the potential effect of various routes of administration, multiple dosing regimens, and variable infusion schedules. These simulations can provide valuable insight into the design of preclinical and clinical studies.

Population Pharmacokinetics and Pharmacodynamics

Population analyses apply standard or custom models to fit in-vivo drug concentration (PK) and drug response (PD) data over a time. They are used in later development phases (II-III) or in special populations (ex. paediatric) when data from many clinical studies must be evaluated at the same time and/or the collection of full PK samples, done in clinical pharmacology or healthy volunteer trials, is not possible.
 
They are powerful but at the same time complex tools to evaluate ADME and drug effect variability in subjects. They are also fundamental to determine the impact on the PK and PD profiles of a large array of covariates of demographic, pathophysiological, environmental, or concomitant drug-related origin.
Using the most popular software, like NONMEM and Certara Phoenix NLME, we can provide the support needed not only to perform complete and robust analyses, but also to have an immediate and practical interpretation of the results in clear written reports that highlight the most important information obtained from the PK/PD models.
 
Regulatory Consulting in Pharmacokinetics
 
CROSS Metrics team, taking advantage of a decade spent in drug development, can provide the advice and support necessary to move forward your pharmacokinetic programs. Solutions are provided through several possibilities: designing appropriate PK studies, performing predictive calculations or power analysis, properly evaluating guidelines, assessor’s requests and incorporating pharmacokinetic and clinical pharmacology technical summaries for regulatory submissions.

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