the world’s largest vaccine site network...the world’s largest vaccine site network supercharged...

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Optimal Vaccine Centers of Excellence The world’s largest vaccine site network

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Page 1: The world’s largest vaccine site network...The world’s largest vaccine site network supercharged with accelerated patient enrollment, advanced lab capabilities, and specialized

Optimal Vaccine Centers of Excellence

The world’s largest vaccine site network

Page 2: The world’s largest vaccine site network...The world’s largest vaccine site network supercharged with accelerated patient enrollment, advanced lab capabilities, and specialized

The world’s largest vaccine site network supercharged with accelerated patient enrollment, advanced lab capabilities, and specialized vaccine services – delivered under a result-based contracting model for total budget certainty.

Superior, standardized qualityPowered by Optimal SOPs, processes, training.

Budget certaintyResults-based commercial termsfor peace of mind.

Introducing Optimal Vaccine Centers of Excellence (OVCoE)

• Expansion of Optimal Vaccine capabilities and Synexus sites into Optimal Vaccine Centers of Excellence.

• Specialized vaccine sites with advanced lab capabilities.

• Proven recruitment strategies allowing OVCoE to never miss an enrollment target on a vaccine study.

• Delivery of all patients needed with dedicated vaccine sites and in half the time using patient-centered approach.

• Enhanced vaccine site network for global reach.

• SOPs: Optimal capabilities and SOP adhered to by all core sites. Reviewed by QA, Medical, and Clinical Operations.

• Training: OVCoE sites complete intensive internal and external training programs in the “Optimal” way.

• All site and enrollment fees rolled into one price per patient, including investigator grants, procedural fees, and recruiting fees.

• No setup fees.

• Capped budgets with the potential for bonus/penalty terms.

• Simplifi ed and centralized contracting across all sites to increase speed of study start-up and maximize site footprint from day one.

• Greater cost and time certainty in trial delivery.

Why OVCoE?

Over

70kpati ents recruited to vaccine trials

Over

1,600Infecti ous

Disease and Vaccine studies

conducted, representi ng over

500 diff erent protocols

Over

850vaccine studies

performed

Over

21,000subjects

randomized into Infecti ous Disease

trials

• Anthrax• Clostridium diffi cile• Cytomegalovirus• Dengue Fever• Ebola• Encephalitis• Group B Streptococcus• HIV• Hepatitis B and C• Herpes Zoster• Human Papilloma Virus• Infl uenza• MMR• Malaria• Meningitis

• Norovirus• Pandemic Infl uenza• Plague• Pneumonia• Respiratory Syncytial Virus• Rotavirus• Seasonal Infl uenza• Smallpox• Smoking Cessation• Tetanus / Diptheria / Pertussis• Tuberculosis• Typhoid Fever• West Nile• Yellow Fever• Zika

Areas of expertise include

Page 3: The world’s largest vaccine site network...The world’s largest vaccine site network supercharged with accelerated patient enrollment, advanced lab capabilities, and specialized

Enhanced vaccine solutionsWith OVCoE, the leading global site network and vaccine specialists work together to optimize productivity and effi ciency for your vaccine clinical trials.

The world-class provider of vaccine clinical trials

• Full-time specialists in vaccine clinical trials.

• Proven recruitment strategies allowing Optimal to never miss an enrollment target on a vaccine study. On-site PBMC processing capabilities with high recovery and viability.

• Experienced with various modes of vaccine delivery and government funded programs and stipulations.

The largest global network of clinical research sites

• Key Synexus dedicated research sites (DRS) (~50) selected based on vaccine capabilities and experience in vaccine clinical studies, level of interest, and equipment present at the sites chosen.

• You can add KOLs and other sites as desired.

+ =

Working together to deliver superior enrollment rates and trial productivity.

Optimal Vaccine Centers of Excellence

The patient’s choice for clinical research

All site and enrolment fees rolled into one price per patient.

Simplified and centralized contracting across all sites to increase speed of study start-up and maximise site footprint from day one.

Each site adopting optimal methodologies.

Optimal … and proven vaccine processes.

35 U.S. Sites

15 Non U.S.

World’s largest dedicated vaccine site network.

Efficient patient enrolment.

Advanced lab capabilities.

Select Synexus vetted sites vaccine experience and capabilities.

6 core optimal sites.

All site and enrollment fees rolled into one price per patient.

Each site adopting Optimal methodologies.

Simplifi ed and centralized contracting across all sites to increase speed of study start-up and maximise site footprint from day one.

Optimal SOP and proven vaccine processes.

35 U.S. sites

15Non U.S.

World’s largest dedicated vaccine site network.

Effi cient patient enrollment.

Advanced lab capabilities.

Select Synexus vetted sites vaccine experience and capabilities. Each network site trained in the “Optimal” way.

6 core Optimal sites.

Page 4: The world’s largest vaccine site network...The world’s largest vaccine site network supercharged with accelerated patient enrollment, advanced lab capabilities, and specialized

Key differentiators

Over 850 studies performed

PI and research staff years of industry experience

Combined Vaccine experience

Experience

Quality

Enrollment Advanced capabilities

Subject retention

Speed

Feasibilities

Contracts (One week) - One Contract, One budget

Data entry / Query resolution

+ Never missed an enrollment goal on a

healthy volunteer study

Willing to guarantee enrollment contractually

Optimal Vaccine CoE Research differentiators

PBMC labs on-site

OVCoE have 5 PBMC labs at selected sites with planned expansion of lab capabilities

Size of the organization, global reach

Clean audit history

Government studies completed

Experienced with government funded programs and stipulations(funding sources include Industry, BARDA/HHS, NIH/NIAID, CDC, DOD, DMID, NMRC)

Average subject retention rate is >97.6%

Expedited study start up times, faster enrollment at fewer sites

Start up timelines - Synexus US v industry average

Nearly

4 x fasterthan the industry

average

Traditional Process(Industry average)

Synexus U.S.

0 2 4 6 8

Months

US +1 480 820 5656UK +44 1257 230723

Email [email protected] www.synexus.com/expertise/vaccines

Optimal Vaccine Centers of Excellence

Contact us today