Excellent planning of your Good Laboratory Practice (GLP) preclinical study for your medical device or combination product is critical for successful translation into the clinic. In the following slides we present helpful hints for study planning to ensure a successful pivotal GLP safety study.

1. 1
PLANNING
The Difference Between
A Successful
Medical Device Preclinical GLP Study
And A Bust
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When going from your
final concept…
to reality
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Planning is
Imperative

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Appropriate GLP
Study Planning
Saves
Time
Money
Animals
Resources
and Headache

5. 5
Have you already conducted non-GLP studies and
are ready to tackle your GLP study? You’re
probably wondering how different the two types of
studies can be.
You need to be sure everyone is on the same
page and following the prescribed plan to
accomplish your goals to get from point A to B.
You don’t have to plan it out exactly but just
need some idea of what your plans are.
Non-GLP Study » Family Camping Trip &
Exploratory Hike
GLP Study » Military Mission
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6. 6
GLP Studies = Confirmation, Not Exploration
• Review the GLP regulations (21 CFR Part 58)
• Consult with FDA on your study plan
• Define your endpoints and stick to them
• No surprises - know what results to expect before you
start
• Data integrity must be defendable at every point
− Training
− Equipment
− Documentation
− DATA
• PLAN, PLAN, PLAN, PLAN
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Over the past decade, as a leading preclinical CRO
performing medical device GLP studies we have
compiled a list of best practices for translation. Our
team is here to support you at every step along the way.

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In the remaining slides
we’ll present useful
hints to consider as
you are planning your
GLP study to help
ensure it isn’t a bust

9. 9
STUDY PLAN &
PROTOCOL
DEVELOPMENT

10. 10
Start study planning early. This can help ensure you
have the personnel and resources necessary for your
study’s success, when you need them.
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Plan for what data will be
collected to support study
objectives as well as your
regulatory and clinical
goals.
• Endpoints should be
clinically relevant
• Each facet of the study
objective will be addressed
with a quantitative
(preferred over qualitative)
study endpoint
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Get input on the study plan from participants and
stakeholders (e.g., surgeon, participating physician,
veterinarian, contract research personnel, pathologist,
regulatory and clinical team members).
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13. 13Docstockmedia/Shutterstock.com
The Surpass Study Director and personnel will work
with you on study planning and generating a GLP study
protocol based on your initial study plan.

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Study Director = Sole Point of Study Control
The more initial information about your study plan, test
articles, timeline expectations, etc. you can provide, the
easier it will be to meet your expectations.
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Each GLP study has
1 protocol that describes
all study objectives and
methods:
• Purpose, experimental
design, control of bias
• Test & control articles
(preparation & delivery)
• Animal model & identification
• Tests, measurements/data to
be collected, analyses (e.g.,
statistical, histopathology
scoring)
• And More FranckBoston/Shutterstock.com

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Design flexibility into the protocol using tolerances,
acceptable ranges and alternatives.Guryanov Andrey/Shutterstock.com

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Determine how you will procure control devices and
specialized medical accessories or equipment for your
study early in the process to avoid time delays that may
impact your study.
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Factor protocol review and report writing time, including
quality assurance auditing time, into your study timeline.
leungchopan
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PLAN FOR
TEST & CONTROL
ARTICLES

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For GLP studies the
Test Article = Intended
Clinical Device (design
freeze). The test article
should be:
• Fully traceable (repeatable
build)
• Sterilized and process
mimics intended
manufacturing process for
clinical device
• Non-expired

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To prevent mix ups and maintain data integrity, test
and control articles must be labeled appropriately:
For more information, check out our blog post on test article labeling for GLP Studies
• Name of the article
• Identifying #(s), e.g., lot #,
batch #, and/or reference #
• Expiration date
• Storage conditions

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Destructive or
Specifications
& Sizing
All Materials &
Coatings
Sterilization
Shelf Life
Stability During Use
Benchtop Testing
Accessories
Specialized accessories
for use with test device
Destructive or non-destructive
testing (e.g. elution rates and
fatigue testing)
May be determined during the
study (e.g. metal breakage,
coating particulation)
Documentation from specific
devices used in the study
For more information, check out our blog post on test article & control article characterization
Alexey Kamenskiy /Shutterstock.com
Documentation of device characterization & stability (as
applies to the study design) must be shared with contract
laboratory… some may be determined as part of the study.

23. 23Andrey VP/Shutterstock.com
If the study > 28 days, plan to retain a sample
for each lot or batch of test & control article.
(If this is not possible, e.g., capital equipment costs, work with the study
director to mitigate this risk.)

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PLAN FOR
EQUIPMENT THAT
WILL BE
PROVIDED TO
THE LAB

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• Sponsors and GLP - Equipment
− Equipment Validated, Calibrated, and Controlled
• Standard operating procedure
• Documented training
• Records of validation, calibration, testing, etc.
• Established plan for handling electronic records
• Resulting data is part of the study – it cannot be removed or altered
GLP - Data Integrity Regulations
Equipment used on GLP studies must
be validated, calibrated, & controlled.

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Each piece of sponsor
provided equipment must
have the following:
• Standard operating
procedure
• Documented training for
personnel running the
equipment
• Records of validation,
calibration, and testing of
equipment

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Establish a plan for handling electronic
records to insure data integrity. Equal
rules apply to electronic as apply to
paper records. They must be well
controlled:
• Traceable
• Retainable
• Unchangeable

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Be aware. Data collected from equipment is part of
the study – it cannot be removed or altered.

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PLAN FOR
PERSONNEL WHO
WILL BE
INVOLVED IN
THE STUDY

30. 30
Equipment used on GLP studies must
be validated, calibrated, & controlled
Personnel involved in a GLP study need to provide the
research facility with a CV (supplementary
documentation of experience may be required and
additional training may be provided, e.g., GLPs, SOPs).
**Evaluate the risk/benefit of involvement due to potential appearance of bias**

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Any notes, pictures,
& video captured in
the OR during a GLP
study must go into
the study file.

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Participating Scientists, including physicians, will need
to prepare a signed and dated participating scientist
report outlining their conclusions for inclusion in the
final study report.
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Contract labs who provide endpoint analyses for the
study (e.g., analytical testing, histopathology,
mechanical testing) will need to give the study director:
• Evidence of GLP compliance
• Input into the protocol
• A signed and dated report to include in the final study
report
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Reach out to Surpass early in the
process so together we can take
steps to ensure a translational GLP
study.
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In Summary: A successful GLP study starts
with good planning.

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The Surpass Team stands ready to assist you as a
knowledgeable partner with study planning, execution,
reporting, and beyond. We have helped translate
hundreds of medical products through successful GLP
studies. We can do the same for you.

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Connect with Surpass
Connect with Surpass on Social Media
• @SurpassInc
• Surpass, Inc
• Surpassinc
Visit our preclinical research blog for more helpful
information on translation research.
Have specific questions about your study or preclinical
research, contact the Surpass Science Team.

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We’re here to support you!