3 Decades of Supporting Efficient Clinical Trials

How Navitas Life Sciences grew to be a Strategic Partner for Top Pharma across the World

Clinical trials are the backbone of modern medical advancements, driving the development of new treatments and therapies that improve patient lives. For the past three decades, Navitas Life Sciences has been at the forefront of supporting and transforming the clinical trial landscape. With an unwavering commitment to innovation, quality, and patient-centricity, Navitas Life Sciences has played a pivotal role in revolutionizing how clinical trials are conducted and managed. Let's embark on a journey through the remarkable evolution of clinical trial support over the last 30 years, as shaped by Navitas Life Sciences.

Efficient Clinical Trials: Building from Strength to Strength

Navitas Life Sciences began as a technology-driven Clinical Research Organization that supported Biotech & Pharmaceutical companies reduce time-to-market and optimize costs while ensuring the highest quality output in the testing of new drugs that improve human health. Driven by knowledge, our evolution into a full-service technology-driven clinical trials partner has seen us building in-house and acquiring life sciences brands.

Navitas Life Sciences recognized the need for comprehensive solutions that would streamline the complex process of conducting clinical trials. We have been proudly providing our expertise and experience to the Life Sciences and Pharma industry for over 30 years, conducting 600+ clinical trials across 20+ different therapeutic areas, including Oncology. Our trial excellence is enhanced by our proprietary OneClinical^® Analytics platform, providing oversight and key data insights.

Vast Therapeutic Expertise

Our extensive experience spans over 20 therapeutic domains, encompassing fields such as Oncology, Neurology, and infectious diseases.

The Evolution of Technology

The complexity of clinical research continues to increase with the emergence of advanced therapies such as biologics, gene therapies and biosimilars, and the need to find suitable therapies for growing health concerns. In this context, it is necessary to invest in the technology to enhance efficiency and obtain vital near real time insights to reduce risk.

Early investment in developing and supporting the right technology has now aided Navitas Life Sciences in ensuring cost and time efficient clinical trials.

Technology and IP

• Full-service Clinical Research Organization with deep acumen in technology and expertise in analytics and data sciences
• OneClinical^® Analytics: AI and analytics-based clinical trials management platform
• Eight unique technology IPs customized around Life Sciences
• The only Company to host nine unique proprietary Life Sciences industry’s network forums

Adapting to a Digital Era

The ongoing digital transformation prompted Navitas Life Sciences to explore innovative solutions like virtual trials, remote monitoring, and wearable devices. These technologies not only increased patient convenience but also allowed for real-time data collection, enhancing data accuracy and reducing trial costs.

Agility during COVID-19- Transformation into virtual and decentralized clinical trials:

During the start of the COVID-19 pandemic, monitoring clinical trials following traditional methods was not possible. Navitas Life Sciences harnessed its technological proficiency and strategic investments to swiftly provide robust support for virtual and decentralized clinical trials. The traditional presence of CRAs or trial monitors at study sites for data review and verification was challenged by restrictions on travel during COVID-19 lockdowns. Vital trial components such as informed consent, adverse event reporting, investigational product management, and data monitoring, typically conducted on-site, demanded remote execution through telecommunication or electronic means. This transition was successfully implemented as there were systems that were already present.

Navitas Life Sciences effectively responded to the challenges posed by COVID-19 lockdowns by leveraging its expertise gained from late-phase studies and adapting it to Phase II and III trials. The organization utilized existing tools and explored novel methodologies to securely access and transmit source documents remotely. Investigators engaged with patients via phone or video consultations. Direct shipment of clinical trial materials, including study drugs, to patients unable to visit the site further exemplifies Navitas' proactive approach.

Decentralized clinical trials- Moving Ahead with Experience and Expertise

Navitas Life Sciences capitalizes on its technological prowess and the insights garnered from the challenges posed by the COVID-19 lockdowns to propel forward with streamlined decentralized clinical trials. The company's adept handling of technology-enabled solutions and the lessons learned during the pandemic lockdowns have laid a strong foundation for the advancement of decentralized trials.

Drawing from its deep reservoir of technological expertise, Navitas Life Sciences has effectively developed and refined systems that enable decentralized trials to operate seamlessly. Navitas Life Sciences has honed strategies for remote patient engagement, leveraging virtual consultations, telemedicine, and electronic communication channels to maintain robust patient participation and data acquisition.

Strategically dispersed around the world, Navitas' Remote Clinical Research Associate (CRA) teams act as primary liaisons with study sites. Each site benefits from a dedicated Site Management Associate (SMA) throughout the study's duration. This personalized approach expedites enrollment and improves retention rates, optimizing both site and sponsor experiences.

The safety of patients remains paramount in remote settings. However, tailored solutions are imperative, considering the unique trial characteristics, patient demographics, protocol, site conditions, and regional factors. Navitas Life Sciences underscores its commitment to precision and adaptability in safeguarding patient well-being.

Patient-Centric Approach

Navitas Life Sciences has always placed a greater emphasis on patient-centricity. Recognizing that patients are at the heart of every trial, Navitas Life Sciences championed solutions that improved patient recruitment, engagement, and retention. Our patient recruitment strategies combined with the availability of patient population, helped trial sponsors identify suitable candidates faster, ensuring trials stayed on track.

Real-World Evidence

In recent years, the industry has seen a shift towards utilizing real-world evidence (RWE) to supplement traditional clinical trial data. The market for Real World Data (RWD) and Real World Evidence (RWE) is anticipated to steadily grow at a Compound Annual Growth Rate (CAGR) of 7.4% from 2022 to 2029. It is projected to reach a value of $1.66 billion by the end of this projected period. RWD and RWE have become highly valuable assets for various life sciences organizations, including those in the government sectors, disease foundations, pharmaceuticals, biotechnology, and medical devices.

Clinical Registries and RWD: Clinical registries encompass databases that include curated data about individuals afflicted by specific illnesses or conditions. These repositories adopt a retrospective and observational approach, necessitating their construction with flexibility and the capacity for growth as the study unfolds. Functioning as valuable sources of Real World Data (RWD), clinical registries offer a good avenue for harnessing essential Real World Evidence (RWE). Navitas Life Sciences supports the development of clinical registries for U.S. Federal Government agencies and life science companies, utilizing Real world Data (RWD).

Excellence in Data Sciences

Navitas Life Sciences excels in delivering top-notch data services, a commitment that extends to their exceptional Functional Service Provider (FSP) offering. With a comprehensive suite of solutions, Navitas Life Sciences is your global partner for all statistical programming, biostatistics, and data management needs.

Our expertise in clinical trial data management extends across the entire spectrum of clinical trial phases within the drug development life cycle. From inception to completion, we provide good data sciences support, ensuring the highest standards of data integrity and analysis.

Whether it is for end-to-end data services or to enhance existing team's capabilities, Navitas Life Sciences seamlessly integrates to fulfill precise needs.

Regulatory Compliance for Faster Market Reach

Regulatory compliance is a cornerstone of successful clinical trials. Navitas Life Sciences is committed to regulatory, ensuring that trial documentation and submissions meet global regulatory standards, enabling faster market reach of drug products.

Strategic Partnerships to optimize your Regulatory Processes

With today’s ever evolving regulatory environment placing increased emphasis on Patient Safety, we successfully navigate the landscape and ensure Patient Safety. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices.

Pharmacovigilance Services

Navitas Life Sciences offers cutting-edge pharmacovigilance services that ensure the safety and well-being of patients while maintaining regulatory compliance for pharmaceutical and life sciences companies. With a steadfast commitment to excellence, we leverage our deep expertise in the field to provide comprehensive solutions that encompass every aspect of pharmacovigilance.

Our Industry Leading Regulatory and Pharmacovigilance Networks

Established in 2011, our industry leading networks are an independent sounding board to test and validate the latest thinking, and uncover industry insight to develop compelling, yet pragmatic strategies to provide business value and meet the needs of patients, payers, and prescribers.

The member community continues to grow, basking on 20+ years of being together. There is more than 90% retention of members, as the insights shared are sought after and highly valuable.

A Truly Global Organization

With a presence across multiple countries and collaborations with numerous global pharmas worldwide, Navitas Life Sciences is a sought-after strategic partner in the global clinical trial landscape. We leverage our expertise to support the market reach of breakthrough treatments across therapeutic areas, ranging from oncology to rare diseases.

Over the past three decades, Navitas Life Sciences has been a driving force behind the evolution of clinical trial support. Our journey reflects an unwavering commitment to innovation, quality, and patient well-being. As we look ahead to the future of clinical trials, Navitas Life Sciences will continue to shape and redefine the industry, ensuring that new therapies reach the patients who need them most.