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The Synexus Model
 What is Synexus?
 Why Synexus Exists
 Synexus Business Models
• Dedicated Research Centre Model
• Affiliated Site Model
 Where Synexus is located
 Patient Engagement – Our Approach
 Our Clinical Experience
 Synexus Quality Management System
 Why does Synexus Succeed?
 Useful Information
Contents
Synexus is a unique company that excels in the
identification, recruitment and retention of
patients in our own clinical sites, on behalf of
leading pharmaceutical companies and contract
research organisations.
Together for the future of health
What is Synexus?
Old Model – Why Synexus Exists
80,000
sites involved in clinical
research
$50,000
spent opening each site
11%
of sites recruit
0
patients
60%
of sites recruit
1
or less patients
86%
of clinical trials do not finish
on time
Locations:
Synexus operates a dedicated research centre model in UK, Bulgaria,
Germany, Hungary, Poland, Romania and South Africa.
Benefits:
The model allows Synexus to recruit large volumes of high quality
patients at a low number of sites.
Results in higher average numbers of patients per Synexus site
compared to the industry average.
By reducing the total number of sites within a study the model allows
Synexus to offer a cost-effective solution to Sponsors and a competitive
advantage to Clinical Research Organisations.
Dedicated Research Centre Model
Locations:
In addition to the DRC model, Synexus operates an affiliated site model
in South Africa, Bulgaria, Ukraine and India to offer a wider reach to
patients across these countries. Synexus has an operational
infrastructure within these countries and established relationships with
external sites and Principal Investigators.
Benefits:
The model supports higher access to patients within these sites via the
Synexus global recruitment strategy.
Affiliated sites work within the Synexus Quality Management System
(SQMS) to provide the high quality service and data our customers
expect from any Synexus site.
Affiliated Site Model
 Superb, modern facilities that make
patients feel at-ease
 State-of-the-art medical equipment
 Purpose designed offices for visiting
monitoring staff
 Significant investment to achieve the
ultimate efficiency gains
 Central to our innovative methodology
Dedicated Research Centres
 130 highly experienced principal
investigators
 174 dedicated nurses caring for our
patients
 All staff are fully trained and
committed to good clinical practice
(GCP)
 Every input double-checked by data
coordinators
 Highest possible standard of care
Equally Dedicated Staff
 Our attention is focused entirely on
conducting clinical trials
 Centralised project management and
operating procedures ensure consistent
quality worldwide
 Flexibility to meet the specific needs of a
study
 Continuous cycle of training, analysis, review
and improvement
 One point of contact and one contract for the
entire trial
 A total solution with every step streamlined
The Power of Focus
Global Network of
25 Dedicated Research
Centres
&
46 Affiliated Sites
UK (8)
Poland (6+1)
Germany (4+2)
South Africa (4+6)
Hungary (1+4)
Romania (1)
Bulgaria (1+2)
Ukraine (+6)
India (+25)
Global Reach
We apply the highest standard of care through their journey with
Synexus
Comfortable waiting rooms
with drinks, snacks & TV
Modern, fully equipped
consulting rooms
Attention on retention.
Patient transport provided
to and from our centres
Close liaison with GP
Detailed patient feedback helps us ensure quality of service
Our Patients are our Number 1 Priority
Feasibility &
Proposal
Validate
Plan
Track &
Forecast
Diagnose &
Optimise
Analysis &
Database
Past
Experience
Our Recruitment Planning is Continuous
It starts with feasibility and continues until the last patient is
recruited and retained
Background
information and
characteristics
analysed
Professional
execution,
monitoring
and fine tuning
Target audience
defined
Recruitment
methods
optimised for local
situation
Building a Recruitment Campaign
Each new campaign is built on the foundation
of all our previous findings and local best practices
We Access and Engage our Patients
Various approaches are used to target approximately
1 million patients within a 30 mile radius of each site
Advertising
• Write to patients from
commercial databases
• Integrated approach (print,
online, radio & TV)
Collaboration for Referrals
• Strong links with professionals
& patient groups to encourage
participation
• Specialist referrals from
cooperating doctors pharmacy
Patient Database
• 630,000+ patients expressed
interest in trials
• Across key TAs and
countries
Community Awareness
• Posters & Leaflets in GP
practices, hospitals, etc.
• Outdoor advertising on
billboards, buses, taxis
• Social media education
GP Relationships
• Engage participating
local GPs to write to
potential patients with
ethically approved letter
Community Liaison
• Interaction with patient
groups and health fairs
• Recruitment team visit
local; centres / clinics
Engaging Patients From The Start
The patient journey
Patients respond to local
recruitment activities and are
tele-screened to assess
specific requirements.
Suitable patients are booked
into the clinic
A non-study visit in which the patient’s medical
condition is characterised
A pre-study visit in which the study and procedures
such as consent are explained
GP SDV initiated to confirm medical history
GP
SDV
Qualified Patient
Our Therapy Areas
Our Clinical Experience
Lipids & Cholesterol Asthma Type I Diabetes
Cardiac Events COPD Type II Diabetes
Hypertension Smoking Cessation Diabetic Foot Ulcer
Heart Failure Osteoporosis Diabetic Neuropathy
Angina Osteoarthritis DPNP
Atrial Fibrillation Ankylosing Spondylitis Alzheimer's Disease
C-Reactive Protein Psoriatic Arthritis Parkinson's Disease
Atopic Dermatitis Rheumatoid Arthritis Restless Leg Syndrome
Acne Human Papilloma Virus Neuralgia
Psoriasis Herpes Zoster Insomnia
Rosacea Influenza Alcohol Dependence
Obesity Travelers Diarrhoea Anxiety
Gout Smallpox Endometriosis
Hyperkalaemia Rotavirus Contraception
Overactive Bladder Neuropathic Pain Menopausal Symptoms
Benign Prostatic Hyperplasia Lower Back Pain Female Sexual Dysfunction
Benign Prostatic Obstruction Knee Pain & Hip Pain HSDD
HIV Prostate Cancer Prevention IBD
Common Cold Tinnitus IBS
Athletes Foot Glaucoma Constipation
Subjects Months Sites
Synexus
per Site
Others
per Site
CV Outcomes 2,740 12 11 249 11
Asthma 1,007 20 24 42 14
Osteoporosis 2,461 10 12 205 30
Diabetes 1,023 11 10 102 10
Osteoporosis 1,763 20 20 88 38
Obesity 710 8 9 79 8
Cancer Prevention 1,500 10 10 150 8
CV Outcomes 1,307 24 24 54 21
Lipids 740 9 24 31 4
Osteoarthritis 300 1.6 7 27 7
Flu Vaccine 1,034 1 4 259 86
Hypertension 1,402 7 7 200 25
Proven Performance
Across a Range of Studies
The aim of the Synexus Quality Management System (SQMS) is to
achieve excellence in data quality for all our customers. We want to:
 Protect patients (care, confidentiality)
 Meet and exceed customer expectations
 Achieve efficiencies through standardisation across the organisation
This is achieved using a global document system comprising of:
 Company Policies
 Corporate Operating Procedures
 Standard Operating Procedures
SQMS ensures consistency of activities across all Synexus sites which, in
turn, ensures that the highest standard of clinical research is achieved.
Synexus Quality Management System
 Conduct all trial activities at our own sites with dedicated
Synexus medics, nurses and support staff
 Proactively recruit patients into clinical trials
 Manage patients throughout the total study lifetime
 Significant cost and time reductions across studies
and entire development programmes
 Underpinned by the Synexus Quality Management System
Why Does Synexus Succeed?
Visit our websites
http://www.synexus.com
https://www.synexusclinic.co.uk
View our videos
http://threemotion.vzaar.me/2034161
https://www.youtube.com/watch?v=JjOF_rsR6Dc
Useful Information

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Synexus Model

  • 2.  What is Synexus?  Why Synexus Exists  Synexus Business Models • Dedicated Research Centre Model • Affiliated Site Model  Where Synexus is located  Patient Engagement – Our Approach  Our Clinical Experience  Synexus Quality Management System  Why does Synexus Succeed?  Useful Information Contents
  • 3. Synexus is a unique company that excels in the identification, recruitment and retention of patients in our own clinical sites, on behalf of leading pharmaceutical companies and contract research organisations. Together for the future of health What is Synexus?
  • 4. Old Model – Why Synexus Exists 80,000 sites involved in clinical research $50,000 spent opening each site 11% of sites recruit 0 patients 60% of sites recruit 1 or less patients 86% of clinical trials do not finish on time
  • 5. Locations: Synexus operates a dedicated research centre model in UK, Bulgaria, Germany, Hungary, Poland, Romania and South Africa. Benefits: The model allows Synexus to recruit large volumes of high quality patients at a low number of sites. Results in higher average numbers of patients per Synexus site compared to the industry average. By reducing the total number of sites within a study the model allows Synexus to offer a cost-effective solution to Sponsors and a competitive advantage to Clinical Research Organisations. Dedicated Research Centre Model
  • 6. Locations: In addition to the DRC model, Synexus operates an affiliated site model in South Africa, Bulgaria, Ukraine and India to offer a wider reach to patients across these countries. Synexus has an operational infrastructure within these countries and established relationships with external sites and Principal Investigators. Benefits: The model supports higher access to patients within these sites via the Synexus global recruitment strategy. Affiliated sites work within the Synexus Quality Management System (SQMS) to provide the high quality service and data our customers expect from any Synexus site. Affiliated Site Model
  • 7.  Superb, modern facilities that make patients feel at-ease  State-of-the-art medical equipment  Purpose designed offices for visiting monitoring staff  Significant investment to achieve the ultimate efficiency gains  Central to our innovative methodology Dedicated Research Centres
  • 8.  130 highly experienced principal investigators  174 dedicated nurses caring for our patients  All staff are fully trained and committed to good clinical practice (GCP)  Every input double-checked by data coordinators  Highest possible standard of care Equally Dedicated Staff
  • 9.  Our attention is focused entirely on conducting clinical trials  Centralised project management and operating procedures ensure consistent quality worldwide  Flexibility to meet the specific needs of a study  Continuous cycle of training, analysis, review and improvement  One point of contact and one contract for the entire trial  A total solution with every step streamlined The Power of Focus
  • 10. Global Network of 25 Dedicated Research Centres & 46 Affiliated Sites UK (8) Poland (6+1) Germany (4+2) South Africa (4+6) Hungary (1+4) Romania (1) Bulgaria (1+2) Ukraine (+6) India (+25) Global Reach
  • 11. We apply the highest standard of care through their journey with Synexus Comfortable waiting rooms with drinks, snacks & TV Modern, fully equipped consulting rooms Attention on retention. Patient transport provided to and from our centres Close liaison with GP Detailed patient feedback helps us ensure quality of service Our Patients are our Number 1 Priority
  • 12. Feasibility & Proposal Validate Plan Track & Forecast Diagnose & Optimise Analysis & Database Past Experience Our Recruitment Planning is Continuous It starts with feasibility and continues until the last patient is recruited and retained
  • 13. Background information and characteristics analysed Professional execution, monitoring and fine tuning Target audience defined Recruitment methods optimised for local situation Building a Recruitment Campaign Each new campaign is built on the foundation of all our previous findings and local best practices
  • 14. We Access and Engage our Patients Various approaches are used to target approximately 1 million patients within a 30 mile radius of each site Advertising • Write to patients from commercial databases • Integrated approach (print, online, radio & TV) Collaboration for Referrals • Strong links with professionals & patient groups to encourage participation • Specialist referrals from cooperating doctors pharmacy Patient Database • 630,000+ patients expressed interest in trials • Across key TAs and countries Community Awareness • Posters & Leaflets in GP practices, hospitals, etc. • Outdoor advertising on billboards, buses, taxis • Social media education GP Relationships • Engage participating local GPs to write to potential patients with ethically approved letter Community Liaison • Interaction with patient groups and health fairs • Recruitment team visit local; centres / clinics
  • 15. Engaging Patients From The Start The patient journey Patients respond to local recruitment activities and are tele-screened to assess specific requirements. Suitable patients are booked into the clinic A non-study visit in which the patient’s medical condition is characterised A pre-study visit in which the study and procedures such as consent are explained GP SDV initiated to confirm medical history GP SDV Qualified Patient
  • 17. Our Clinical Experience Lipids & Cholesterol Asthma Type I Diabetes Cardiac Events COPD Type II Diabetes Hypertension Smoking Cessation Diabetic Foot Ulcer Heart Failure Osteoporosis Diabetic Neuropathy Angina Osteoarthritis DPNP Atrial Fibrillation Ankylosing Spondylitis Alzheimer's Disease C-Reactive Protein Psoriatic Arthritis Parkinson's Disease Atopic Dermatitis Rheumatoid Arthritis Restless Leg Syndrome Acne Human Papilloma Virus Neuralgia Psoriasis Herpes Zoster Insomnia Rosacea Influenza Alcohol Dependence Obesity Travelers Diarrhoea Anxiety Gout Smallpox Endometriosis Hyperkalaemia Rotavirus Contraception Overactive Bladder Neuropathic Pain Menopausal Symptoms Benign Prostatic Hyperplasia Lower Back Pain Female Sexual Dysfunction Benign Prostatic Obstruction Knee Pain & Hip Pain HSDD HIV Prostate Cancer Prevention IBD Common Cold Tinnitus IBS Athletes Foot Glaucoma Constipation
  • 18. Subjects Months Sites Synexus per Site Others per Site CV Outcomes 2,740 12 11 249 11 Asthma 1,007 20 24 42 14 Osteoporosis 2,461 10 12 205 30 Diabetes 1,023 11 10 102 10 Osteoporosis 1,763 20 20 88 38 Obesity 710 8 9 79 8 Cancer Prevention 1,500 10 10 150 8 CV Outcomes 1,307 24 24 54 21 Lipids 740 9 24 31 4 Osteoarthritis 300 1.6 7 27 7 Flu Vaccine 1,034 1 4 259 86 Hypertension 1,402 7 7 200 25 Proven Performance Across a Range of Studies
  • 19. The aim of the Synexus Quality Management System (SQMS) is to achieve excellence in data quality for all our customers. We want to:  Protect patients (care, confidentiality)  Meet and exceed customer expectations  Achieve efficiencies through standardisation across the organisation This is achieved using a global document system comprising of:  Company Policies  Corporate Operating Procedures  Standard Operating Procedures SQMS ensures consistency of activities across all Synexus sites which, in turn, ensures that the highest standard of clinical research is achieved. Synexus Quality Management System
  • 20.  Conduct all trial activities at our own sites with dedicated Synexus medics, nurses and support staff  Proactively recruit patients into clinical trials  Manage patients throughout the total study lifetime  Significant cost and time reductions across studies and entire development programmes  Underpinned by the Synexus Quality Management System Why Does Synexus Succeed?
  • 21. Visit our websites http://www.synexus.com https://www.synexusclinic.co.uk View our videos http://threemotion.vzaar.me/2034161 https://www.youtube.com/watch?v=JjOF_rsR6Dc Useful Information

Editor's Notes

  1. Synexus site photos are of:- Frankfurt/Frankfurt Leipzig/Leipzig Dresden/Dresden
  2. India sites Bangalore Trivandrum
  3. Elevated CRP – AZ, Jupiter Cancer Prevention – GSK, REDUCE Diabetes Prevention – Novartis, NAVIGATOR Osteoporosis – Merck, POWER Obesity – Abbott, SCOUT CV Outcome – Pfizer, ASCOT Flu Vaccine – GSK Hypertension – Servier, PREMIUM
  4. As of Feb 2011 - 142 documents issued in SQMS