RoeLee

RoeLee Users Area

Software Home

Introduction:

RoeLee is developed, enhanced and supported by the statistical and computing specialists at P.N.Lee Statistics and Computing Ltd with advice from experienced pathologists. Since its first release in 1984 new features have been added continuously and is now used worldwide by major corporations and individual pathologists alike.

• A Histopathology and Necropsy system for Windows 9x, NT, 2000 & XP (other platforms can be supported if required).
• Excellent data entry, reporting and statistical analysis facilities.
• A powerful Peer Review System is now also available to accompany RoeLee. The Peer Review system is can be used as a standalone application to work alongside your existing system
• Import and analyse data from other major histopathology systems  such as PATHDATA,  XYBION  etc
• Export data in many formats including  FDA electronic submission via  SAS transport files
• FDA 21CFR Part 11 compliance.   Our thoughts on RoeLee and 21 CFR Part11
  Recently the FDA have become more concerned about the use and submission of electronic records and as such have issued guidelines in 21 CFR Part11. We have taken these FDA guidelines on board and a new version RoeLee 3.1 is available which will help your company achieve 21 CFR Part11 compliance.

At PNLSC we aim to give an all-round service to our clients. Help on using RoeLee, on statistical problems and on computing are all just a phone call away. PNLSC also carry out analyses of pre-clinical and clinical data, using RoeLee for many major companies.

Histopathology        More info on RoeLee Histopathology     Software Home

Entry of histopathology data is made simple and consistent by using grading systems to classify findings. Grading systems, findings and organs can be specified in a user-specific lexicon, or set up as encountered during data entry. The abbreviations used for these are chosen by the user.

RoeLee includes:-

• Blind numbering
• Tumour coding: benign, malignant, metastases or multi-centric
• Sex-specific and/or paired organs
• Factors contributory to death and predominant pathology
• Data validation against standard or client-specified criteria.

Necropsy       More info on RoeLee Necropsy     Software Home

RoeLee provides for input and reporting of necropsy data. This includes:-

• Multi-user data entry
• Organ weights transferred directly from balance to system
• Production of slide preparation forms
• Reporting of lesions grouped by topography.

The necropsy data may be accessed during slide reading:-

• Organs missing or abnormal at necropsy are highlighted on histopathology screens
• Full necropsy details can be viewed during histopathology data entry
• Validation of histopathology data against necropsy data
• Joint reports of necropsy and histopathology findings.
  

Reporting      More info on RoeLee Reports and Tables     Software Home

All the standard necropsy and histopathology reports and many more exist in RoeLee:-

• Reports which meet the requirements of the FDA, EPA and Japanese MAFF
• Correlations between necropsy and histopathology findings
• Factors contributory to death
• Histograms and Plots including Kaplan-Meier.

RoeLee allows the user to:-

• Select animals by organ, finding, tumour type and/or animal number
• Report a whole study at the push of a button using 'Command Files' tailored to the client's requirements
• Output to any combination of screen, file and printer.
• Control page layout - headings, footnotes, table and page numbers, margins and tabs
  

Statistical Analysis     More info on RoeLee Statistical Analysis     Software Home

RoeLee provides all the major statistical tests required. The user can control many factors including:-

• Sexes - combined, separate, one sex only
• Tumours - inclusion/exclusion of non-neoplastic findings, primary tumours, multicentrics, metastases
• Selection of animals
• Age-adjustment and stratification
• Reporting of missing values
• Comparisons - pair-wise, trend, heterogeneity
• Transformations of data to give new data fields for analysis and reporting.

RoeLee can also be used to summarise Historical Control data and to analyse In-life data. The flexibility of the system also allows recording and analysis of data from clinical trials.

Security

RoeLee has many security features:-

• Access control by passwords
• Levels of access
• Audit trail
• Data integrity following system crashes.
• FDA 21CFR Part 11 compliance.   Our thoughts on RoeLee and 21 CFR Part11
  Recently the FDA have become more concerned about the use and submission of electronic records and as such have issued guidelines in 21 CFR Part11. We have taken these FDA guidelines on board and a new version RoeLee 3.1 is available which will help your company achieve 21 CFR Part11 compliance.

Interfaces

RoeLee can:-

• Import and analyse data from other major histopathology systems
  • ACOPAT
  • DATATOX
  • PATHDATA
  • PLACES
  • XYBION
• Export data in a number of formats, including Rich Text Format (RTF), for inclusion in the client's preferred reporting software
• Export data in the format required for reporting to the FDA including SAS export format.
• Interfaces to and from ROELEE can be produced quickly to meet the client's special requirements.

Interfaces have also been written for systems such as SPSS and PARADOX. These interfaces give users the power to use ROELEE to analyse all the conditions in a study using quick, powerful statistical functions specially designed for this type of study. Users can also use the ROELEE tabulations and reporting facilities to get the special reports needed for regulatory authorities which may not be available in their own data entry systems. With their wide experience of writing such interfaces, PNLSC are confident of dealing with data from almost all computer data entry systems.