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 provides expert and innovative advice on a wide range of aspects of clinical trial designs.
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


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


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


Pharmacokinetic 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 PK analysis of Phase I PK studies, including in vitro - in vivo correlations (IVIVC) of sustained-release formulations, bioequivalence, food effect, drug interaction and special population PK , drug exposure and drug recovery data. We also provide assessments of PK/PD relationships.

Pharmacokinetic Simulations

Based on the existing PK data simulation analysis to predict the plasma concentration profile of a drug under various input conditions are performed. This information allows to preview 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.

Pharmacokinetics Consulting

The PK team, taking advantage of decades spent in drug development, can provide you with the advise and support necessary to help advance your pharmacokinetic programs. Solutions are provided in designing appropriate pharmacokinetic studies, perform correct calculations, power analysis and incorporate pharmacokinetic and clinical pharmacology technical summaries for regulatory submissions.

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