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

80,000sites involved in clinical

research

$50,000spent 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 CampaignEach 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 StartThe 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 ExperienceLipids & 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 PerformanceAcross 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 websiteshttp://www.synexus.comhttps://www.synexusclinic.co.uk

View our videoshttp://threemotion.vzaar.me/2034161https://www.youtube.com/watch?v=JjOF_rsR6Dc

Useful Information