Marty Boom | Global Head Regulatory & Safety | Navitas Life Sciences | Navitas Life Sciences

Marty Boom | Global Head Regulatory & Safety | Navitas Life Sciences

“ we hold 8 life sciences focused technologies that have been developed to meet the unique needs of the industry and provide a single source of truth. the unique technologies developed for regulatory affairs and pharmacovigilance enable organizations to be compliant with the latest regulatory requirements ”

"PROVIDING A SINGLE SOURCE OF TRUTH"

Navitas Life Sciences is a full-service, technologydriven Clinical Research Organization (CRO) with operations across the globe. They specialize in Clinical Trials, Regulatory Affairs, and Pharmacovigilance across the complete product lifecycle, supporting innovator and generic biopharma companies to bring their products to market quickly and effectively. “Our clients are looking for a partner to support them in increasing operational efficiencies and reducing costs, while ensuring high quality, regulatory compliant, outputs,” says Marty Boom, Global Head Regulatory & Safety, Navitas Life Sciences. “Our clients range from top global pharma majors, to biotech organizations, to smaller companies with just one or two products in the market. We are proud to work with US Federal government institutions like the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Center for Disease Control (CDC), to name a few.”

Navitas Life Sciences is a well-established technology partner for the life sciences industry, providing technologies that drive successful outcomes and provide a single source of truth. They provide application infrastructure for regulatory, content management, quality, track and trace, serialization, and business intelligence. Global standards are adopted and institutionalized across all services covering ISO, GAMP5, GxP, and 21-CFR Part 11 compliance needs. These alignments ensure that the product or services offered are in line with the statutory requirements of all regulatory bodies.  

Our regulatory technologies are:

Intuitively operated platforms

* The most economical for regulatory submissions in the industry and enable faster product approvals and commercialization

* Fully integrated, compliant, web-based platforms to create and manage your global regulatory submissions either on premise or cloud based.

Our regulatory technologies empower core advantages:

* Standardize - achieve global and local regulatory compliance

* Optimize - provide streamlined holistic processes

* Align - global cross-functional alignment with internal & external business roles

* Accelerate - shortening the overall timeline for submission

* Save cost - cloud based or on-premise economical solutions for small, medium & large pharma

Navitas Life Sciences built the next-generation mobility platform, traceREADY, as a device-independent application that can interface with many ERP, non-ERP, and custom solutions. With the life sciences industry constantly looking for ways to ensure compliance through highly efficient and consistent processes, traceREADY delivers a high-quality solution enabling extended ERP transactions and other Enterprise Applications for various industrial and personal mobile smart devices using Windows, Android, etc. or iOS platforms. As a standalone package, this technology helps the client collect data and control the operations at the “Point of Action.” This enables easy implementation of SOPs and audit readiness with accurate data at all times. 

Navitas Life Sciences’ traceREADY is a device-independent application that can interface with many ERP, non-ERP, and custom solutions. Pharmaceutical industries are constantly looking for ways to ensure compliance through highly efficient and consistent processes. traceREADY delivers a highquality solution for the multitude of challenges faced in the pharmaceutical industry. traceREADY helps to address the industry’s unique needs like distinctive manufacturing, raw material needs, accounting, and planning.  

Their established traceREADY was built in 2011 for extended ERP transactions and other enterprise applications for a variety of industrial and personal mobile smart devices using Windows, Android, or iOS platforms. Designed with life sciences in mind, traceREADY provides the perfect solution to improve your day-to-day operations, enhancing and making consistent the product development phase, improving operational performance, and meeting the challenges of stringent regulations.

This platform avoids complex middleware for integration and uses a dynamic rendering engine to configure data collection screens. This platform facilitates additional system controls in real-time during operations, reduces information latency, and improves data accuracy. This application works in online/ offline modes so that the application is minor dependent on WiFi, proving cost-effective for remote work locations that lack stable network connections. The architecture is highly scalable to handle many users and provides redundancy, reliability, and disaster recovery.

Key Benefits:

Life science companies face the constant challenge of being competitive as well as profitable. This creates a need to better streamline processes, with a shift in focus from isolated systems to a more integrated approach for a better control of the process. Both medium and large pharmaceuticals have leveraged the services rendered by our platform to enhance their outcomes.

It is pertinent to mention, Navitas Life Sciences has supported 550+ Clinical Trials covering 120,000+ patients across 20+ therapeutic areas. We have conducted over 1,100 bioavailability & bioequivalence studies and developed over 300 bioanalytical methods, aiding generics companies to bring their products to market. We have enabled over 180,000 regulatory submissions globally and have further supported over 300 safety consulting engagements. Sone of their case studies are as below: 

Navitas Life Sciences is a leader in Life Sciences. Since 2001, we have hosted unique industry leading Life Sciences industry networks where industry peers are part of an independent sounding board, testing and validating the latest thinking, and uncovering industry insight to develop compelling yet pragmatic strategies to provide business value and meet the needs of patients, payers, and prescribers.  

“ We hold 8 Life Sciences focused technologies that have been developed to meet the unique needs of the industry and provide a single source of truth. The unique technologies developed for Regulatory Affairs and Pharmacovigilance enable organizations to be compliant with the latest regulatory requirements ”

Today, we host 10 such forums across the spectrum of Pharmacovigilance, Regulatory Affairs, and Clinical Research. With over 120 member companies, our network forums are vibrant communities which foster innovation and accelerate growth. 

Our annual benchmark provides members with the opportunity to understand and improve their performance; and enriches our organization with unique and deep industry insights. The insights derived from our networks feed into our services and enable us to develop industry specific IPs that keep us at the leading edge of the industry. Our clients benefit from these rich insights, both in terms of cost and quality. We invest in the future of the industry, with technologies and services that enable our clients to meet the challenges of tomorrow, today.  

We have always believed in investing in the right technology, and our constant endeavor to strengthen our technical capabilities has helped us maintain business continuity during the pandemic. We are proud to have conducted multiple COVID-19 clinical trials as well as non-COVID clinical trials by leveraging our technology IPs.

We hold 8 Life Sciences focused technologies that have been developed to meet the unique needs of the industry and provide a single source of truth. Our unique technologies developed for Regulatory Affairs and Pharmacovigilance enable organizations to be compliant with the latest regulatory requirements. Our products include: pharmaREADY®, traceREADY, idmpREADY, labelREADY, rimREADY, safetyREADY, and affiliateREADY each addressing a unique need of the industry, bringing in efficiency and reducing cost. OneClinical® Analytics, our Artificial Intelligence (AI) driven platform, enables virtual clinical trials to run efficiently.

Our innovative Regulatory Technology, pharmaREADY®, achieved 200 active customers driving accelerated compliance and delivering first-time-right submissions. With regulatory requirements having evolved, becoming more complex, costly, and global in scope life sciences companies are being forced to compete, innovate, and execute faster than ever before. First launched in 2005, pharmaREADY® is a fully integrated, regulatory compliant, web-based platform to create, view, and manage global regulatory submissions. We continue to evolve our technology to ensure a robust product suite with multiple modules including: Document Management System (DMS), electronic Common Technical Document (eCTD), Structured Product Labeling (SPL), and Training Records Management System (TRMS), to meet global regulatory requirements.

“Our clinical facilities comply with the International Council of Harmonization – Good Clinical Practices (ICH-GCP). Our laboratories are certified by the College of American Pathologists’ Laboratory Accreditation Program and are also ISO 15189:2012 (Medical Laboratories – Requirements for quality and competence) certified,” Marty Boom. “Our facilities based in Bangalore and Chennai are ISO 9001:2015 and ISO 27001:2013 certified. Our facilities have been successfully audited by health authorities (like US FDA) and clients over 40 times, with no significant findings.” 

Marty Boom adds, “Around 25% of our global team comprise of domain experts (medical doctors, PhDs, and biostatisticians), with an average of ten years of hands-on experience in clinical trials and drug development. We have been recognized as Major Contenders in the Everest Group’s Pharmacovigilance and Complaint Management Operations – Services PEAK Matrix® Assessment 2021.” 

Navitas Life Sciences provides high-quality, end-to-end, Clinical, Regulatory, and Safety services, and their offerings are backed by deep domain experience and unique technical expertise. They are proud to have supported 10+ COVID-19 clinical trials that promise to bring effective therapies to market in humanity’s time of need. Time and again, they have impressed clients with their ability to deliver on time, enabling them to meet stringent deadlines and get to market quickly. This is because they augment their clinical capabilities with technology enablers to allow seamless execution and quick results. A stellar example of this is a recent engagement with a mid-sized pharma company looking to bring a new therapy to the market to treat moderate to severe COVID-19 cases. “We accomplished study milestones even before the committed timeline, provided our client with real-time data dashboards to enable them to make quick decisions, and delivered effective remote monitoring at site level while maintaining high quality standards,” explains Marty Boom. “Our excellent delivery was highly appreciated by our client, for whom we are now the preferred partner for multiple COVID-19 studies.” 

During the recent COVID-19 pandemic, OneClinical®, a proprietary Analytics platform that provides near real-time data insight to take proactive action, has proven highly effective in enabling the remote monitoring of clinical trials, allowing us to support both COVID-19 trials, as well as multiple non-COVID clinical trials in oncology, ophthalmology, and infectious  diseases areas. “We managed Pharmacovigilance for several COVID-19 trials and performed the submission management and publishing activities for one of the leading vaccines,” says Marty Boom. “We pride ourselves on offering our clients the perfect blend of clinical capability, technology expertise and regulatory services to run virtual trials in these unprecedented times.”