Post on 19-Jul-2019
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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
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.
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 bd@synexus.comVisit www.synexus.com/expertise/vaccines
Optimal Vaccine Centers of Excellence
Contact us today