Data Management within a Contract Research Organization

1
Data Management within a Contract Research
Organization

• Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
• Premier Laboratory, LLC

2
Objectives

• Discuss how a histology contract laboratory
  implemented digital scanning capabilities (Aperio
  Scanscope) along with a web-based data management
  system (Spectrum Plus) to increase the level of
  customer service and quality of work we provide
  to our clients.

3
Our Initial Goals

• Initially purchased scan scope to create whole
  slide digital images
• Primary focus was due to the increasing number of
  image analysis projects we were working on
• Image capture was labor intensive and quality and
  appropriate selection of images depended upon the
  level of training and education of the individual
  taking the images
• Lots of merged images in Adobe Elements (not
  ideal)
• Image analysis capabilities and whole slide image
  analysis was intriguing and a way increase
  quality of data
• Revenue stream, set us apart from other CROs

4
The Learning Curve

• The more time we spent working with both the scan
  scope and the spectrum plus data base the more we
  saw how this could really impact the level of
  service and level of quality we could provide to
  our clients
• It was a great match for us since our business
  core values was to provide a quality product with
  an increased level of customer service we can
  provide our clients

5
Basic Services

• Receive slides, scan slides, burn DVDs, ship
  slides and DVDs back to client
• 1 and place slides up on Spectrum for
  approximately 30 days
• 1 and place slides up on Spectrum indefinitely

6
Security of Remote Log In

• With Spectrum Plus we are able to create secure
  user IDs and passwords for each separate client
• When a client logs in they are only have access
  to their images
• In administrative functions we can select how
  much control each user has
• Managing client confidentiality
• Its really EASY!

7
Scanning for other CROs

• Some of our clients are other CROs so they have
  clients also and their clients also want to be
  able to view the images.
• the CRO does not need to give out their user ID
  and password (potentially see other clients
  images)
• create a user ID and password for the client of
  the CRO and then give the CRO access to those
  images

8

• as administrator we have control over all
  accounts, we are
• able to add, delete or change user accounts
  keep an excel
• spreadsheet of user IDs and passwords, clients
  can not change
• passwords
• users are only able to access their images and
  can not make
• any changes to their account
• there are different levels of control no
  access, read only and
• full control
• most clients have full control - able to take
  snapshots, create
• annotations, take measurments.

9
Client Training - Minimal

• Accessing images through spectrum is very easy.
• Send off an e-mail to the client with basic
  instructions
• Provide additional training if required
• phone conversation
• E-mail
• Go to meeting
• Digital conferencing Spectrum Feature

10

• The scanned images of your slides are on our
  server. Please follow the instructions below to
  gain access to your images.
• You will need to download the free shareware from
  Aperio from the following link, you do not need
  to fill in any info if you choose not to just
  click the download now button http//www.aperio.co
  m/download.asp
• To gain access to your images you will need to go
  to the following IP address http//mail.premierla
  b.com
• The Spectrum Page should come up
• your username is SamplesSlides (this is case
  sensitive)
• your password is premier
• The software is relatively user friendly, but if
  you have any questions please feel free to
  contact us.
•  

11
Increased Customer Service

• Routine protocol development
• Clients have immediate access to images during
  the development stages. They have the ability to
  essentially QC check our process. Increases
  communication between us and the clients which
  will increase customer service and satisfaction.
• review results of pilot samples
• check for proper orientation
• check for correct area of interest
• check for correct staining patterns

12
Case Study 1

• Client submitted rat brain sections, already
  trimmed to a specific area of interest. They
  wanted CEV staining of both the anterior and
  posterior hippocampus at specific levels
• processed to paraffin cut 4 levels initially
• scanned slides
• client was able to view slides and direct us
• Review on Spectrum

13
Immunohistochemical Protocol Development

• Great way to work with clients during
  immunohistochemical protocol development
• Immediate access to results from titer studies
• Spectrum allows us to upload documents
• Antibody development spreadsheet
• Final protocol if necessary
• Methods for publications
• Antibody specification sheets

14
Case Study 2

• Client wanted us to develop several antibodies on
  mouse collagen arthritis sections
• able to review all slides, annotate areas of
• interest or concern, take snapshots
• able to access our development methods
• able to access our final protocol
• able to access materials and methods for
• publications
• Review on Spectrum

15
Data from Entire Project is Available on Spectrum

• Projects may consist of multiple types of samples
  with varying analysis methods
• data from aperio algorithms linked to slide
• images captured from methods other than the
  aperio or from other analysis methods
• data from the project
• report, tables, graphs, gross images, procedures,
  etc. all can be uploaded to Spectrum

16
Case Study 3

• Multiple analysis in a femoral artery balloon
  injury model in rabbits. Looked at frozen
  sections, paraffin sections and En Face
  analysis of the Thoracic Aorta.
• Since all of the data and images is located in
  one spot it makes it easy to review data and
  draft reports
• Review on Spectrum

17
Case Study 4

• Muscular Dystrophy Model Mdx Mice
• Receive multiple muscles from Mdx mice
• Multiple analysis parameters
• Pathology (inflammation, fibrosis, myodystrophy)
• Centrally localized nuclei and atrophied cell
  counts
• Fiber diameter, fiber area, etc.
• Review on Spectrum

18
Case Study 5

• DHE (supraoxide staining) of mouse femoral
  arteries, frozen sections, ethidium bromide cube
  for fluorescence.
• uploaded fluorescence captured tiff images
• into the spectrum data
• analyzed via batch analysis through
• spectrum and Aperios algorithms
• calculated intensity of staining

19
Summary

• Immediate access to images
• Upload images not generated with ScanScope
• Upload data or other files related to the study
• Easy way to review all data associated with a
• particular project
• Implementation of whole slide digital imaging
  along with the Spectrum Plus database has allowed
  us to expand our services, improve the quality of
  services we provide to our clients and also
  increase the level of customer service.

20
A big thanks to Aperio and everyone back in the
lab. Without either of them I would not have had
the opportunity to give this presentation.