5 Key Capabilities in Managing Vaccine Clinical Trials

August is National Immunization Awareness Month, supported by the U.S Centers for Disease Control and Prevention (CDC), to highlight the need to follow vaccination schedules. Over the past year and a half, the COVID-19 crisis has brought to the fore the importance of vaccines, making terms like mRNA vaccines, vaccine trials, and vaccine benefits ubiquitous than ever before.

Guidelines for Vaccine Development

There are stringent guidelines put forward by the European Medicines Agency (EMA), the World Health Organization (WHO), and the United States Food and Drug Administration (USFDA) in bringing vaccines to the market.

Very few vaccine candidates make the transition from the laboratory to clinical trials and the typical criteria to advance development are immunogenicity profile in animals, toxicology, risk benefit profile for the general population, contribution to public health and ultimately the expected acceptance and uptake of the vaccine by the general public.

Navitas Life Sciences’ Stellar Vaccine Trial Capabilities

Navitas Life Sciences has the experience and expertise to support vaccine clinical trials with agility and speed required to bring such life-saving medication to the market quickly and efficiently. Our ability to adapt, growing footprint and strong associations with sites has helped us conduct a variety of vaccine programs across.

5 Key Capabilities in Managing Vaccine Trials

Clinical research on Infectious disease and vaccine development has a widespread effect on the entire community. At Navitas Life Sciences, our Vaccine Clinical Trials unit is devoted to ensuring advancement in this significant field of work. Here are 5 key capabilities that help promote successful outcomes

1) Vast Experience in Managing Vaccine Clinical Trials: Navitas Life Sciences has vast experience in managing clinical trials, partnering with numerous small to large pharmaceuticals, biotech companies and Government agencies to bring drug products to the market. This experience has provided the necessary insights to run efficient trials that are cost and time efficient.

2) Experts in the field of Vaccine Science: Navitas has the depth and the breadth of expertise necessary for therapeutic alignment to conduct best-in-class vaccine clinical study teams. We also forge deep partnerships with key opinion leaders for strengthening capabilities.

The successful conduct of a vaccine development program requires an in-depth understanding of the epidemiology, awareness, involvement of local health professionals and government, possible collaboration with the national immunization programs and overall benefit of the vaccine to the population. Moreover, vaccines are received by healthy individuals, making safety margin a critical aspect.

Scientific support and Deep Understanding hosted by Navitas Life Sciences

• Experts with a broad range of expertise across various infectious diseases
• A deep understanding of preventive as well as therapeutic vaccines
• Expertise across immunologic and anti-infective drug products
• Scientific-know-how to support Phase I to IV trials across the globe
• Expert medical team to update database with incidence and epidemiological trends in real time
• Highly trained team to handle vaccine studies that works with KOLs and Investigators to ensure smooth execution
• Regulatory support for planning and study start-up globally.
• Expertise to effectively navigate the multi-layered requirements and stringent timelines put forward by U.S Government agencies.

3) Robust Site Relationships: Navitas Life Sciences has access to multiple sites that allow efficient start of clinical trials.

Navitas Life Sciences Strong Site Relationship

• Long-term and strong relationships with multiple sites across countries
• Technological capability to monitor site health and provide near real time updates
• Robust understanding of cold-chain management and required sample handling conditions
• Access to experienced central labs with expertise in supporting immune assays and required laboratory tests

4) Patient Centric Measures to Manage Wide Patient Population: Life Sciences has more than 25000 healthy volunteers, with 700 post-menopausal women, and patients with cancer, diabetes, hypertension and renal disease. This has aided in recruiting study participants during the pandemic, ensuring that milestones were adhered to at all times.

Navitas Life Sciences’ Patient Population

• 120000+ patients
• 25000+ healthy volunteers
• 700+ Post-menopausal women
• Patients with cancer, diabetes, hypertension and renal disease
• Patient centric methodologies are constantly updated and adopted to facilitate effective trials, especially in pediatric population.
• Technology platforms are also harnessed to consistently monitor patient safety for enhanced decision making during the trial.
• Ability to scale and enroll patients across a wide range of target populations

5) Technological Prowess to Raise Clinical Trial Value: OneClinical provides near real time data during the trial, which can be used to better control challenges during a trial. The use of such intelligent analytics allows proactive corrective action, aiding in resolving critical issues at the onset. This will help in intelligent deployment of resources that can save time and money.

Navitas Life Sciences constantly renews core systems to ensure effective support of new digital functionalities for significant improvement in the efficiency of clinical trials. Vaccine clinical trials are nuanced and require the right experience and expertise to provide high quality data and for successful outcomes. An integration of multiple key aspects and capabilities has helped power robust solutions that greatly accelerate delivery while maintaining or even improving patient comfort.

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