Vaccines
91黑料 has lead the development of 15 vaccines resulting in FDA/EMA approvals, including the world’s first approved vaccine for COVID-19.
We work with global biotech, pharma, government and NGOs in the design, execution, and commercialisation of vaccines to prevent infectious diseases.
The number of new and re-emerging infectious diseases continues to rise and pose a threat to world health. Our global team have built up extensive vaccine expertise, with over 200 years of experience across our leadership team alone. This enables us to anticipate the challenges in your drug development plan and consistently beat aggressive vaccine start up timelines and enrolment goals. We focus on driving your milestone success and on providing high quality deliverables within budget.
Our work has resulted in 15 vaccine approvals by the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA). And our team have winners of “Best CRO” at the Vaccine Industry Excellence (ViE) Awards three times (2020, 2017 and 2014) and have been named a finalist every year since 2011.
We are also prime contractors for the US Government and qualified provider for the . Our broad portfolio of services and global footprint also serve the needs of other global health organisations such as , and .
91黑料 vaccine experience in the last five years
-
180+
Studies conducted -
425,000+
Patients involved -
6,200+
Sites worldwide
Experience our partners can trust
Our team understands the urgency, complexities, and potential challenges associated with running trials in normal times. We conducted over 130 COVID-19 trials and have extensive prophylactic vaccine study experience. 91黑料 provided clinical trial services to the Pfizer and BioNTech SE investigational COVID-19 vaccine programme. We make data-driven recommendations and apply best practices to execute your study, while safeguarding trial participants. By selecting us as your contract research organisation (CRO) partner, you will benefit from:
- A leadership team focused specifically in vaccines with well over 200 years of combined experience in vaccine clinical development who provide insight into your protocol and strategies to operationalise execution
- Direct involvement in the design, implementation and / or execution of clinical trials
- Specialised, scalable infectious disease and vaccine-experienced resources ready to deploy for your studies
- Global Site Network and Patient Solutions comprised of 91黑料’s proprietary vaccine-experienced sites with PBMC isolation capabilities that are prepared to conduct COVID-19 vaccine trials
- FIRECREST digital solutions including an Investigator Portal for document distribution and protocol-specific training for site staff
Vaccines experience & capabilities
Our vaccine research experience encompasses prophylaxes for seasonal, vector, sexually-transmitted, enteric and other viral and bacterial infections across all populations including maternal participants.
Vaccine types
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Watch the videos below for an overview of 91黑料's experience and capabilities in vaccines, including details of vaccine types, participant populations and indications, as well as the range of our services.
Our Vaccines service offerings
Our extensive services include:
- Clinical monitoring and study management
- Expert consultation and operational delivery Phase I-IV
- Life cycle management and outcomes research protocol development
- Regulatory consultancy with phase specific quality systems
- Medical affairs and pharmacovigilance
- Data management and biostatistics
- Vaccine government experience
- Patient recruitment
Accellacare, 91黑料's Global Site Network
, 91黑料's Global Site Network combines our proprietary site network and healthcare alliance sites across North America, Europe, Africa and Middle East to provide greater access to patients and multi-specialty physicians for our clients. This network of research sites, offers proven, professional clinical research resources and infrastructure for your clinical research.
?Adaptive design trials
We are the only full service CRO with the knowledge, software, systems, and global footprint to make adaptive clinical trials a reality. Our full service includes the design, simulation, and execution of adaptive clinical trials that can be effectively applied in these studies.
Digital solutions for education and automation to increase efficiency in clinical trials
FIRECREST digital solutions provide you with the tools and support to move your training on line - whether it is the training that you would usually deliver in group meetings or the training that CRAs provide on site.
The FIRECREST Study Portal, which is fully customisable to your study, provides single sign-on to a range of education and automation solutions. Connectivity to site and study staff will lead to increased engagement and improved study performance.
Infectious diseases and vaccines insights
91黑料's Infectious Diseases and Vaccines teams contribute regularly to media and industry conversations in addition to the production of thought leadership content in the form of whitepapers and blogs.