2. Who are MESM?
Exclusive to the Clinical Trial Industry
Global Medical Equipment Solutions
Full product lifecycle management
Purchase or hire options
Working across Global Clinical Trials at all phases
Equipment ensures successful Clinical Trial
Facilitating your compliance with GCP/Sunshine acts
ECG’s
CENTRIFUGES
INFUSION PUMPS
FREEZERS
3. Typical Clinical Study Equipment
Examples of MESM Clinical Supply Products
ECG’s
Purchase or hire
REFRIGERATION
CENTRIFUGES BP MONITORS DEFIBRILLATORS PATIENT MONITORS
EBC
EQUIPMENT
SPIROMETERS FREEZERS DATALOGGERS BALANCES
CAPNOGRAPHS
PULSE
ORIMETERES
WEIGHING SCALES INFUSION PUMPS ULTRASOUND
TEMPERATURE
MONITORING
THERMOMETERS ULTRA LOW
TEMPERATURE
FREEZERS
INCUBATORS SYRINGE PUMPS
4. Our Commitment To Every Clinical Trial
EBC
EQUIPMENTECG’s
Purchase or hire
REFRIGERATION
CENTRIFUGES BP MONITORS DEFIBRILLATORS PATIENT MONITORS
SPIROMETERS FREEZERS DATALOGGERS BALANCES
CAPNOGRAPHS
PULSE
ORIMETERES
WEIGHING SCALES INFUSION PUMPS ULTRASOUND
TEMPERATURE
MONITORING
THERMOMETERS ULTRA LOW
TEMPERATURE
FREEZERS
INCUBATORS SYRINGE PUMPS
Providing the right equipment
to the right place
at the right time
5. Advantages of using MESM
• Clinical Supply is MESM’s core
competency
• Business exclusive and intrinsic to
Clinical Trials
• Alleviates resourcing issues from
Sponsor/CRO/Central Lab
• Most efficient way to outsource
equipment
Clinical Supply
Specialists – Increased
Efficiency
• Equipment can be aligned to
Clinical Trial protocols
• Laboratory equipment supplied in
line with Laboratory Manual
• Standard Footprint of high quality
equipment used across all clinical
trials
• Bespoke requests
Equipment
Consultation Solutions
• Quantitative Real Time Diagnostic
solutions
• Enables Patient decisions to be
made real time
• Enables studies to be run quicker
• Improves patient Recruitment and
Retention
Innovation
• Eliminates need to contract with
multiple different companies
who provide a smaller range of
products
• Enables easier traceability and
ordering for all products
• Single Account Manager deeply
involved with your studies
Contract with a single
vendor for all
equipment
requirements
• Our asset management systems
allow you to easily view where
you have placed product.
• Can also quickly understand which
specific sites have which
equipment
• Can also track, trace and
automatically reorder
consumables via expiry or usage
Greater equipment
visibility
• Global Technical Support
• Calibration Solutions
• Extended warranties
• End of study collection
• Equipment Storage
• Refurbishment and Redeployment
• Local Sourcing
• Total Study Budgeting
Global Added value
services
6. Shift of Local to Global Study at Phase 2/3 resulting in having to work around another countries
regulations and logistics in Medical Equipment – Not a sponsor core competency or area of
expertise
Example of issues moving to Global Study with regards to Medical Equipment – Is importation
licence required? Is product approved in all countries involved in study? Have you considered
importation tax into country?
If Importation Licence is required in country, who will broker the import where possible? If
product is not registered for use in country, or cannot be imported due to logistical reasons, who
will source and implement a local product solution?
Equipment maintenance and certification – Does sponsor have Global and Local solutions
implemented ahead of study and equipment usage? What happens if equipment has technical
issue on site during trial? Who will calibrate Medical equipment where recommended under GCP?
Who is managing records of equipment purchased and installed at site level by sponsor for Clinical
Trial use? Who will collect the equipment at the end of the study from the site and who will
store/destroy the product? Important considerations under the Sunshine Act.
All areas outlined above are part of MESM’s core competencies and areas of expertise.
Typical Complexities of Clinical Supply
7. Your Clinical
Trial
Requirements
Your Clinical
Trial
Complexity
MESM
Understands
MESM Added Value Services
Providing Unique Solutions to the Clinical Trial Market
1. I cannot purchase equipment as it
needs to be collected at the end of the
study
2. My study is 3 years long and the
equipment needs to be calibrated
each year
3. What happens if my equipment fails
during the study?
4. Our Clinical Protocol outlines a
product we are unfamiliar with, how
can you help?
1. The study is going to be running in
countries we are unfamiliar with
2. If we import product into this country,
we are going to pay a large amount of
importation tax
3. The site staff will not be familiar with
the product we need to supply for this
clinical trial
4. Some of the items we provide have an
expiry date, how can this be
managed?
MESM Added Value Services
1. MESM will still collect and manage
the equipment at the end of the
study, even where purchased
2. MESM have a global network of
medical engineers who are trained to
carry out calibration of medical
equipment
3. MESM have a network of Medical
Engineers who can attend site to
repair equipment
4. MESM have a consultative approach
and are experienced in almost all lines
of equipment, we are happy to help!
MESM Added Value Services
1. MESM have solutions and experience
in the majority of countries where
Clinical Trials operate, our expertise
will certainly be of benefit
2. MESM have a number of local supply
options for countries where
importation is difficult or import tax
is expensive
3. MESM can create bespoke training
material for your clinical trial in
numerous mediums
4. MESM have an internal asset
management system and can resupply
clinical sites based on expiry, usage or
both.
Increased
Efficiency
8. Important Factors we consider with all Clinical
Trial Supply
Product
Sourcing
Product
Knowledge
Country
Knowledge
Import
/export
Logistics
Installation
Training
Technical
Support
Service
Support
Asset
Tracking
End of
Study
options
Liability
risk
i
i
i
i
i
ii
i
i
i
i
9. ECG
BP
MONITOR
CENTRIFUGE
SCALES
DATA
LOGGERS
FREEZER
THERMOMETER SYRINGE
PUMP
REFRIGERATOR
FILTERSLINES
Do you require any other
patient monitoring
equipment?
What are you
storing?
Blood
Do you need
to spin the
blood down?
DrugBlood
How is drug
administered?
Orally
Does patient
weight affect
dose amount?
Yes
What are
you
centrifuging?
Are these going to
be used in drug
dose calculation?
Infusion
How is drug stored?
Rev1:RC/13
Key:
Outbound
Inbound
In/Out
Consultative Product Relationship
MESM Thinking Ahead…
10. Experienced Global Logistics
Product Licensing
Import/Export Specialists
Cold Chain/Consumable Storage
Our Specialised Departmental Structure
Global Specialist Courier Solutions
Supplier/Partner Relations
Country Specific Requirements
Local/Global Sourcing Options
Sourcing
And Purchasing
Asset management/End Of life options
Equipment Installation/Calibration
Global Network of qualified Engineers
Multilingual Technical Support
Service
DepartmentSingle Key Contact for all sites
Purchase or Hire
Asset Tracking
Multilingual Account Co-ordination
Logistics
Department
Sales and
Account
Management
Varying Industry Experts working in harmony towards the same shared goal under the MESM
umbrella – Providing Global Medical Equipment Supply Excellence Exclusive to Clinical Trials
11. Best Practice Partnerships
MESM best
practice
Mutually agreed MSA
•Outlines prices, products,
timelines, services,
responsibilities etc.
•Defines all contractual aspects
•Allows uniformed and agreed
way of working
Forecast upcoming Clinical
Studies
•Allows us to understand
upcoming workload around
products required, countries
involved.
•Enables MESM to correctly
resource for Business needs
Obtain Clinical Trial Protocols for
current and upcoming studies
•Allows MESM to fully understand
why the equipment is being used,
and also identify areas where
equipment may be required
•Protocol also supported by
Laboratory Manual to understand
any equipment requirements
around Laboratory Type Equipment
Mutually agreed CDA
•Allows MESM and your
company to talk
confidently around
clinical studies, and be
open around other
partners involved
Assign company dedicated Account
Manager
•Gives your business a single point of
contact who acts as liaison with all
individuals involved in study equipment
•Account Manager holds close ties with
cross functional departments. Escalates
and coordinates all activity including
shipping, technical support etc.
•Escalates any issues into Senior
Management as outlined in
Communication protocol
Hold Bi-Annual Performance
Reviews
•Review between MESM Senior
Management and yourselves
•Allows MESM to review their
performance from your
perspective
•Enables us to learn from current
way of working, take on-board
comments and implement into
best practice
•Improve moving forward
13. Innovating Clinical Trials – Next Generation
MESM also provide Innovative Equipment Solutions
around Quantitative Real Time Diagnostics (QRTD)
also known as Point of Care (POC)
QRTD can change the way Clinical Trials are run,
opening up a wealth of benefits and efficiencies to
the Clinical Trial Market
These solutions are patient focused, whilst
expediting Clinical Trials, enabling faster
compound to market and an improved level of
patient care
These Portable Devices, with miniature chemistry
reagent systems open up over 50 biomarker
solutions that can be measured next to the patient
in as little as 2 minutes.
QRTD can be applied and used across all disease
areas
14. What QRTD will bring to you
Improved Patient
Compliance and
Retention
• Simplification of
study procedures
• Elimination of
excess study
burden for subjects
• Better patient
recruitment via
more appealing
study management
• More efficient
study management
Ability to expedite
recruitment
processes
• Enables patients to
be randomised and
dosed on day of
presentation
• Allows for earlier
interventional
treatments
resulting in better
endpoint data
• Eliminates
cumbersome
waiting times and
delays
• More efficient drug
pathways
Closer monitoring of
vulnerable patients,
or known drug risks
• Real time
monitoring of
patient biomarkers
• Safety testing
immediately prior
to next dose
administration
• Allows for trials to
be run in more
vulnerable patient
populations due to
increased safety
Greater revenue
potential
• Faster market
access for
Investigational
Products
• Ability to
demonstrate
product
efficaciousness
more efficiently
• Reduction in study
costs due to
streamlined
processes
• Further patient
group reach
15. Definition - Quantitative Real Time Diagnostics
A solution which provides laboratory accurate biomarker testing “on-
site” in a much reduced timeframe (15 minutes) on whole blood
samples, utilizing simpler procedures and reduced error compared to
current methodology.
These devices are not operated by laboratory professionals, but staff
who are in direct contact with the patient, the devices are very simple
in design and process, making training of staff quick and efficient.
This is a truly patient focused concept, whereby all features and
benefits are aimed at both improving patient safety and convenience.
MESM hold Clinical Partnerships with QRTD manufacturers to place
their products into the Clinical Trial Industry
16. Current Methodology
Patient Presents
Sample Taken for
analysis to Include/
Exclude
Sample is
centrifuged and
stored for
collection
Sample is collected
and sent to lab
Sample received by
the laboratory and
analysed
Results are
generated by the
laboratory and
liaised to site
Site receives
results and decides
on
inclusion/exclusion
Process
usually takes
30-60 hours
17. QRTD Methodology - Recruitment
Patient Presents
Sample taken to
include/exclude
Cartridge dosed
and inserted into
device
Result generated
Site decides on
inclusion/exclusion
Process
usually takes
15 to 30
minutes
18. Commercial Oncology Usage
Patient tested
in clinic
•Patient has whole blood sample
collected into Lithium Heparin
tube
•Cartridge is dosed with the sample
– no pre-analytic steps required
Device
performs test
•Cartridge is inserted into device
•After 12 minutes the results are
displayed and printed
Results
generated and
interpreted
• Patient receives dose of
chemotherapy depending
on results generated
Eliminates patient waiting times
due to local laboratory delays
Enables better patient
throughputTHEREFORE
19. Commercial Cardiovascular Usage
Patient
presents in
ED
•Cardiovascular disease is suggested
•Depending on symptoms, test is
selected
Sample
collected
•Patient has whole blood sample
collected into Lithium Heparin tube
•Cartridge is dosed with the sample –
no pre-analytic steps required
Device
performs
test
• Cartridge inserted into device
• Device takes 10 minutes to
perform test from start to
finish
Results
generated and
interpreted
• Result of test can identify past MI
• Can identify and stage HF
• Treatment can begin immediatelyFaster identification of such
diseases allows treatment to be
given much faster
Patient prognosis improved
20. Implementing these products into Clinical Trials..
MESM are the market leaders in providing
these solutions into the Clinical Trial Industry,
the following slides example how and why
these devices are being used…
QRTD is not a replacement for a Central Lab
Service, but a true alternative where biomarker
analysis is needed in a very short turnaround
time
QRTD can be considered a valid
option instead of a local laboratory
service
Efficiency
Time
21. Example Case Study 1
A trial designed to investigate a Cardiac Disease aims to
include/exclude, randomise and dose with IP in under 24 hours from
patient presentation. Investigation of early intervention with study
medication into this disease to meet better endpoints.
• Involves Quantitative Cardiac Biomarker
assay which must be over a defined
threshold for inclusion to the study
• Onsite testing for infectious diseases, any
positive result excludes patient from the
study
• These tests are run alongside ECG, HR,
patient weight etc by Investigator
Inclusion
exclusion
• The Cardiac disease in this case is acute,
the study team aims to understand
whether very early intervention from
patient presentation improves
morbidity/mortality in this disease.
• Therefore, very early inclusion/exclusion
and randomisation is key to this
procedure. Outcome of this study is very
important for endpoint purposes.
Study Aim • Study drug is already established in the
treatment of this disease area, however,
this has the potential to become a
blockbuster drug if administered early
into presentation
• Study teams would not be able to
perform Biomarker assays required to
include patients onto this study in the
short time frame required.
Without QRTD
22. Example Case Study 2
A study drug with known potential hepatic toxicity is being
administered in the investigation of a chronic progressive
disease, with the aim of improving clinical scores and
reduction in disease burden
• Involves Quantitative Liver Function Tests
performed on site by the investigator. The
result of these tests are interpreted and
the site makes a decision on whether the
patient can accept another IP dose.
Pre-dose
safety testing
• The patients in this study are of high
dependency due to disease burden,
making repeat trips to investigator sites
extremely difficult.
• Having testing and dosing performed at
the same visit improves patient
compliance and retention.
Study Model • Patients would have to make twice the
number of trips to site due to the lack of
local laboratory testing services performed
at the investigator sites.
• This puts pressure on the patients and
also their friends and family who are
usually responsible for taking the patient
to site. Without QRTD, the patients would
have higher study obligations, resulting in
higher non-compliance
Without QRTD
23. Patient
Recruitment
Reducing number of
required study visits
•By performing all testing
required for next dose “on
site”
•Patient is less burdened by
study obligations
How can QRTD improve patient recruitment
•As study burden is not as high during the
course of the trial
•Especially important where patients have
high disease burden and dependency on
family/friends
Likelihood of study fatigue is
reduced
•Less SAE’s = better patient retention
•Especially important with vulnerable
population groups such as paediatric
•Allows for confidence in trial whereby a
potential risk is identified
Real-time biomarker monitoring
reduces likelihood of SAE’s
Retention
24. Streamlined Study Processes
• Results in faster study completion
• This enables the next phase of the study to
commence earlier
• AND/OR Faster Compound to Market
• Also would reduce associated study cost due to
reduced timelines required
• Can also reduce cost due to much lower
shipment volumes of cold chain samples
More intelligent study design
• Would allow for endpoint to be met with higher
efficiency (such as in the case of earlier
intervention)
• This would demonstrate a higher drug
efficaciousness and therefore easier compound
to market post study phase
• Critical for acute disease that can cause end
organ damage if not treated immediately
Greater patient populations
• Bespoke protocols written for at risk individuals
with greater safety management allows
medication to be approved in these populations
• This increases potential patient access post study
completion and therefore higher revenue
potential
Greater Financial Potential
• QRTD can be intelligently utilised to expedite clinical studies by streamlining
processes and removing unnecessary delays. Or bespoke utilization to target
additional patients.
